Page last updated: 2024-12-11

isavuconazole

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Description

isavuconazole : A 1,3-thiazole that is butan-2-ol which is substituted at positions 1, 2, and 3 by 1,2,4-triazol-1-yl, 2,5-difluorophenyl, and 4-(p-cyanophenyl)-1,3-thiazol-2-yl groups, respectively. It is an antifungal drug used for the treatment of invasive aspergillosis and invasive mucormycosis. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID6918485
CHEMBL ID409153
CHEBI ID85979
SCHEMBL ID939038
MeSH IDM0496090

Synonyms (59)

Synonym
ro-0094815
asp9766
4-[2-[(1r,2r)-2-(2,5-difluorophenyl)-2-hydroxy-1-methyl-3-(1,2,4-triazol-1-yl)propyl]thiazol-4-yl]benzonitrile
benzonitrile, 4-[2-[(1r,2r)-2-(2,5-difluorophenyl)-2-hydroxy-1-methyl-3-(1h-1,2,4-triazol-1-yl)propyl]-4-thiazolyl]-
isavuconazole
bal-4815
bal4815
bal-8557(pro-drug)
chebi:85979 ,
CHEMBL409153
4-[2-[(1r,2r)-2-(2,5-difluorophenyl)-2-hydroxy-1-methyl-3-(1h-1,2,4-triazol-1-yl)propyl]-4-thiazolyl]benzonitrile
4-[2-[(2r,3r)-3-(2,5-difluorophenyl)-3-hydroxy-4-(1,2,4-triazol-1-yl)butan-2-yl]-1,3-thiazol-4-yl]benzonitrile
241479-67-4
60uto373ke ,
ro 0094815
unii-60uto373ke
bal 4815
isavuconazole [inn]
S3722
4-(2-((2r,3r)-3-(2,5-difluorophenyl)-3-hydroxy-4-(1h-1,2,4-triazol-1-yl)butan-2-yl)-1,3-thiazol-4-yl)benzonitrile
isavuconazole [mi]
isavuconazole [who-dd]
4-{2-[(1r,2r)-2-(2,5-difluoro-phenyl)-2-hydroxy-1-methyl-3-[1,2,4]triazol-1-yl-propyl]-thiazol-4-yl }-benzonitrile
DDFOUSQFMYRUQK-RCDICMHDSA-N
4-{2-[(1r,2r)-2-(2,5-difluoro-phenyl)-2-hydroxy-1-methyl -3-[1,2,4]triazol-1-yl-propyl]-thiazol-4-yl}-benzonitrile
(2r,3r)-3-[4-(4-cyanophenyl)thiazol-2-yl]-1-(1h-1,2,4-triazol-1-yl)-2-(2,5-difluorophenyl)-butan-2-ol
CS-3492
DTXSID2058251 ,
SCHEMBL939038
4-{2-[(2r,3r)-3-(2,5-difluorophenyl)-3-hydroxy-4-(1h-1,2,4-triazol-1-yl)butan-2-yl]-1,3-thiazol-4-yl}benzonitrile
isavuconazol
isavuconazolum
4-(2-((2r,3r)-3-(2,5-difluorophenyl)-3-hydroxy-4-(1h-1,2,4-triazol-1-yl)butan-2-yl)thiazol-4-yl)benzonitrile
AC-31076
HY-14273
isavuconazole (inn)
D10750
AKOS027250772
1286730-05-9
mfcd06407745
J-015363
NCGC00390646-01
bal-4815;ro-0094815
bal-4815;bal4815;bal 4815;ro-0094815;ro0094815;ro 0094815
BCP07587
Q6079042
DB11633
AS-30128
CCG-269093
NCGC00390646-02
EX-A1785
isavuconazole; bal-4815; ro-0094815
4-(2-((2r,3r)-rel-3-(2,5-difluorophenyl)-3-hydroxy-4-(1h-1,2,4-triazol-1-yl)butan-2-yl)thiazol-4-yl)benzonitrile
A899541
bdbm50595118
j02ac05
dtxcid6032069
2r,3r)-3-[4-(4-cyanophenyl)thiazol-2-yl]-2-(2,5- difluorophenyl)-1-(1h-1,2,4-triazol-1-yl)butan-2-ol
EN300-7401534

Research Excerpts

Overview

Isavuconazole (BAL4815) is a promising novel broad-spectrum triazole in late-stage clinical development that has proven active in vitro against Aspergillus and Candida species. It is approved for the treatment of invasive aspergillosis and mucormycosis. IsavuConazole is a safe therapeutic option for IMD in SOT recipients with efficacy comparable to other patient groups.

ExcerptReferenceRelevance
"Isavuconazole (BAL4815) is a promising novel broad-spectrum triazole in late-stage clinical development that has proven active in vitro against Aspergillus and Candida species. "( In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
Bouza, E; Guinea, J; Peláez, T; Recio, S; Torres-Narbona, M, 2008
)
2.07
"Isavuconazole is a triazole with broad-spectrum activity against medically important fungal pathogens. "( Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
Denning, DW; Hope, WW; Majithiya, J; Parmar, A; Sharp, A; Warn, PA, 2009
)
2.04
"Isavuconazole is a triazole antifungal drug, approved for the treatment of invasive aspergillosis and mucormycosis. "( Interaction between flucloxacillin and azoles: Is isavuconazole next?
Debaveye, Y; Lagrou, K; Spriet, I; Van Daele, R; Vandenbriele, C; Vos, R; Wauters, J, 2021
)
2.32
"Isavuconazole (ISA) is an alternative treatment for Aspergillus spp. "( Safety and Effectiveness of Isavuconazole Treatment for Fungal Infections in Solid Organ Transplant Recipients (ISASOT Study).
Berastegui, C; Bravo, C; Campany-Herrero, D; Castells, L; Deu, M; Gavaldà, J; Len, O; Los-Arcos, I; Márquez-Algaba, E; Martín-Gómez, MT; Monforte, A; Moreso, F; Nuvials, X; Sacanell, J; Sempere, A, 2022
)
2.46
"Isavuconazole is a triazole antifungal drug that has shown good efficacy in human patients. "( Pharmacokinetics of isavuconazole in healthy cats after oral and intravenous administration.
Dear, JD; Wittenburg, LA; Woerde, DJ, 2022
)
2.49
"Isavuconazole is an antifungal drug used for treatment of invasive fungal infections. "( Isavuconazole plasma concentrations in critically ill patients during extracorporeal membrane oxygenation.
Eller, P; Gringschl, Y; Hatzl, S; Hoenigl, M; Krause, R; Kriegl, L; Meinitzer, A; Muhr, T; Prattes, J; Reisinger, AC; Schilcher, G; Zurl, C, 2022
)
3.61
"Isavuconazole is a convenient triazole antifungal agent with a broad antifungal spectrum. "( Efficacy and safety of isavuconazole against deep-seated mycoses: A phase 3, randomized, open-label study in Japan.
Akashi, K; Izumikawa, K; Kakeya, H; Kamei, K; Kanda, Y; Kimura, SI; Kishida, M; Kohno, S; Matsuda, M; Miyazaki, T; Miyazaki, Y; Mukae, H; Niki, Y; Ogawa, K; Okada, F; Suzuki, J; Takazono, T; Taniguchi, S; Tateda, K; Yoshida, M, 2023
)
2.66
"Isavuconazole is a safe therapeutic option for IMD in SOT recipients, with efficacy comparable to other patient groups."( Isavuconazole for the Treatment of Invasive Mold Disease in Solid Organ Transplant Recipients: A Multicenter Study on Efficacy and Safety in Real-life Clinical Practice.
Aguado, JM; Bodro, M; Carratalà, J; Cordero, E; Fariñas, MDC; Fernández-Ruiz, M; Fortún, J; Goikoetxea, J; Gutiérrez Martín, I; Illaro, A; López-Viñau, T; Moreno, A; Muñoz, P; Ramos-Martínez, A; Rodriguez-Álvarez, R; Ruiz-Ruigómez, M; Sabé, N; Salto-Alejandre, S; Valerio, M; Vidal, E, 2023
)
3.8
"Isavuconazole (ISA) is a new triazole antifungal agent that has shown promising efficacy in the prophylaxis and treatment of invasive fungal diseases."( Clinical research advances of isavuconazole in the treatment of invasive fungal diseases.
Feng, S; Shen, Y; Zhang, T, 2022
)
1.73
"Isavuconazole is a triazole with broad-spectrum antifungal activity. "( Post-hoc analysis of the safety and efficacy of isavuconazole in older patients with invasive fungal disease from the VITAL and SECURE studies.
Aram, JA; Engelhardt, M; Hamed, K; Huang, JJ; Kovanda, LL; Yan, J, 2023
)
2.61
"Isavuconazole is a novel triazole antifungal agent. "( A systematic review and meta-analysis of efficacy and safety of isavuconazole for the treatment and prophylaxis of invasive fungal infections.
Asai, N; Hagihara, M; Hirai, J; Iwamoto, T; Kato, H; Mikamo, H; Mori, N; Umemura, T; Yamagishi, Y, 2023
)
2.59
"Isavuconazole is an antifungal which has been approved to treat IFIs, but it has not been approved to prevent IFIs."( A plain language summary on preventing fungal infections with isavuconazole in people with blood-related conditions.
Aram, JA; Bellmann, C; Hongmei, J; Inês, M; Macmillan, T; Penack, O; Ping, Y; Webb, N, 2023
)
1.87
"Isavuconazole is a drug that remains largely unstudied, especially for fungal infections that develop at the site of a break in the skin, such as a wound. "(
Almeida-Paes, R; Almeida-Silva, F; Bernardes-Engemann, AR; Coelho, RA; Corrêa-Junior, D; Fichman, V; Frases, S; Freitas, DF; Galhardo, MC; Zancopé-Oliveira, RM, 2023
)
2.35
"Isavuconazole (ISA) is a newer antifungal used in patients with history of hematologic malignancies and hematopoietic transplant and cellular therapies (HM/TCT). "( Breakthrough invasive fungal infections on isavuconazole prophylaxis in hematologic malignancy & hematopoietic stem cell transplant patients.
Anderson, A; Camargo, JF; Chandhok, NS; Jabr, R; Khatri, AM; Komanduri, K; Morris, MI; Natori, A; Natori, Y; Raja, M; Shah, SA, 2023
)
2.62
"Isavuconazole is a broad-spectrum antifungal agent for the management of invasive fungal disease. "( Population Pharmacokinetics of Total and Unbound Isavuconazole in Critically Ill Patients: Implications for Adaptive Dosing Strategies.
Brüggemann, RJM; Debaveye, Y; Jansen, AME; Mertens, B; Schouten, J; Spriet, I; Ter Heine, R; Verweij, PE; Wauters, J, 2023
)
2.61
"Isavuconazole is a broad-spectrum azole that is FDA-approved for the treatment of aspergillosis and mucormycosis; data on the use of isavuconazole for the treatment and prevention of other invasive fungal infections are limited. "( Treatment Failure of Isavuconazole in a Patient with Cryptococcosis.
Gandhi, TN; Linder, KA; Miceli, MH, 2019
)
2.28
"Isavuconazole (ISV) is a recently approved azole with a promising interaction and safety profile."( Successful Treatment of Severe Aspergillosis with Isavuconazole Therapy after Allogeneic Stem Cell Transplantation.
Anguita, J; Bailén, R; Balsalobre, P; Buño, I; Diez-Martin, JL; Dorado, N; Guinea, J; Kwon, M; Machado, M; Oarbeascoa, G; Padilla, B; Pradillo, V; Sancho, M; Serrano, D, 2019
)
1.49
"Isavuconazole is a new azole approved for adults with invasive aspergillosis and mucormycosis, with a favorable hepatic tolerability reported in Phase III trials. "( Isavuconazole-induced Acute Liver Failure in a Pediatric Patient With Invasive Aspergillosis.
Brivio, E; Foresti, S; Migliorino, GM; Rovelli, A; Verna, M; Zucchini, N, 2019
)
3.4
"Isavuconazole is a novel triazole with broad-spectrum activity that has shown good blood-brain barrier penetration in animal models."( Isavuconazole for the treatment of patients with invasive fungal diseases involving the central nervous system.
Cornely, OA; Hamed, K; Heinz, WJ; Herbrecht, R; Maertens, J; Marty, FM; Rahav, G; Schwartz, S, 2020
)
2.72
"Isavuconazole is a broad-spectrum triazole approved for treatment of invasive fungal infections (IFIs). "( A Single-Center, Open-Label Trial of Isavuconazole Prophylaxis against Invasive Fungal Infection in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation.
Barker, J; Bogler, Y; Giralt, S; Gyurkocza, B; Lee, YJ; Papanicolaou, GA; Perales, MA; Seo, S; Shaffer, B; Stern, A; Su, Y; Tamari, R, 2020
)
2.27
"Isavuconazole (ISAV) is an extended spectrum mold-active triazole and has superior tolerability and fewer significant drug-drug interactions compared with other triazoles."( Isavuconazole as Primary Antifungal Prophylaxis in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome: An Open-label, Prospective, Phase 2 Study.
Bivins, CA; Borthakur, G; Bose, P; Daver, N; Estrov, Z; Huang, X; Kadia, TM; Kantarjian, HM; Konopleva, M; Kontoyiannis, DP; Marx, KR; Masarova, L; McCue, D; Naqvi, K; Pemmaraju, N; Pierce, SA; Qiao, W; Rausch, CR; Ravandi, F; Takahashi, K; Wiederhold, NP; Wurster, S; Yilmaz, M, 2021
)
2.79
"Isavuconazole is a new triazole that has shown efficacy in adults for primary and salvage treatment of mucormycosis."( Isavuconazole As Successful Salvage Therapy for Mucormycosis in Pediatric Patients.
Ashkenazi-Hoffnung, L; Ben-Ami, R; Bilavsky, E; Fischer, S; Grisaru, G; Levy, I; Nahum, E; Novikov, A; Sadot, E; Scheuerman, O, 2020
)
2.72
"Isavuconazole is a triazole antifungal available in IV and capsule formulation. "( Achievement of clinical isavuconazole blood concentrations in transplant recipients with isavuconazonium sulphate capsules administered via enteral feeding tube.
Anderson, AD; Andes, DR; Borlagdan, J; Davis, MR; Lepak, AJ; Marini, RV; McCreary, EK; Nguyen, MH; Rivosecchi, RM; Sacha, LM; Shields, RK; Silveira, FP, 2020
)
2.31
"Isavuconazole is a newer broad-spectrum antifungal agent with promising efficacy and safety."( Isavuconazole for the prophylaxis and treatment of invasive fungal disease: A single-center experience.
Jacobs, SE; Rana, MM; Saunders-Hao, P; Vu, CA, 2021
)
2.79
"Isavuconazole appears to be a promising alternative for prophylaxis and treatment of invasive fungal disease. "( Isavuconazole for the prophylaxis and treatment of invasive fungal disease: A single-center experience.
Jacobs, SE; Rana, MM; Saunders-Hao, P; Vu, CA, 2021
)
3.51
"Isavuconazole is a cost-effective treatment compared to voriconazole for patients with possible IA for a willingness to pay threshold of 25,000€ per additional QALY."( The cost-effectiveness of isavuconazole compared to voriconazole, the standard of care in the treatment of patients with invasive mould diseases, prior to differential pathogen diagnosis in Spain.
Azanza, JR; Grau, S; López-Gómez, V; López-Ibáñez de Aldecoa, A; Peral, C; Rebollo, P; Vázquez, L, 2021
)
2.36
"Isavuconazole (ISA) is a frequently used antifungal agent for the treatment of invasive fungal diseases (IFDs). "( Principal-agent theory-based cost and reimbursement structures of isavuconazole treatment in German hospitals.
Cornely, OA; Jeck, J; Kron, F; Lazzaro, C; Thielscher, C; Wingen-Heimann, SM, 2021
)
2.3
"Isavuconazole is a broad-spectrum triazole for the treatment of invasive fungal disease (IFD)."( Clinical experience with isavuconazole in healthy volunteers and patients with invasive aspergillosis in China, and the results from an exposure-response analysis.
Aram, JA; Cao, G; Cornely, OA; Desai, A; Fayyad, R; Guo, X; Hamed, K; Wu, D; Zhang, J; Zhang, Y, 2021
)
2.37
"Isavuconazole is a triazole antifungal drug, approved for the treatment of invasive aspergillosis and mucormycosis. "( Concomitant use of isavuconazole and CYP3A4/5 inducers: Where pharmacogenetics meets pharmacokinetics.
Brüggemann, RJ; Debaveye, Y; Dreesen, E; Elkayal, O; Guchelaar, HJ; Lagrou, K; Spriet, I; Van Bleyenbergh, P; Van Daele, R; Vermeersch, P; Vos, R, 2021
)
2.39
"Isavuconazole is a safe and reliable antifungal agent in complex hematological patients, with relatively low hepatotoxicity and QTc interval shortening properties."( Clinical Considerations of Isavuconazole Administration in High-Risk Hematological Patients: A Single-Center 5-Year Experience.
Chalandon, Y; Glampedakis, E; Kronig, I; Masouridi-Levrat, S; Neofytos, D; Van Delden, C; Vernaz, N, 2021
)
2.36
"Isavuconazole is a new triazole approved for the treatment of invasive aspergillosis. "( Isavuconazole susceptibility of clinical Aspergillus fumigatus isolates and feasibility of isavuconazole dose escalation to treat isolates with elevated MICs.
Brüggemann, RJM; Buil, JB; Meis, JF; Melchers, WJG; Mouton, JW; Verweij, PE; Wasmann, RE; Zoll, J, 2018
)
3.37
"Isavuconazole is a new triazole antifungal agent with official indications for the treatment of invasive fungal infections caused by Aspergillus and Mucormycosis."( A Review of the Clinical Pharmacokinetics and Pharmacodynamics of Isavuconazole.
Wilby, KJ, 2018
)
1.44
"Isavuconazole is a novel antifungal drug approved for the treatment of adults with invasive aspergillosis and mucormycosis. "( Isavuconazole shortens the QTc interval.
Bassetti, M; Cornely, OA; Dörfel, D; Hagel, S; Lehners, N; Mellinghoff, SC; Plis, A; Schalk, E; Vena, A, 2018
)
3.37
"Isavuconazole is a new drug that shows promise in the adult population for the treatment of IMIs."( Successful treatment of invasive mucormycosis with isavuconazole in pediatric patients.
Barg, AA; Bartuv, M; Greenberg, G; Keller, N; Malkiel, S; Toren, A, 2018
)
1.45
"Isavuconazole is a triazole antifungal agent for treatment of invasive aspergillosis and mucormycosis. "( Validation of an Isavuconazole High-Performance Liquid Chromatography Assay in Plasma for Routine Therapeutic Drug Monitoring Applications.
Karasch, I; Lakner, J; Mueller, SC; Wacke, R, 2018
)
2.26
"Isavuconazole is a triazole previously shown to have potent in vitro activity against Aspergillus spp., Mucorales and Candida spp. "( Isavuconazole is highly active in vitro against Candida species isolates but shows trailing effect.
Bouza, E; Escribano, P; Gómez, A; Guinea, J; Marcos-Zambrano, LJ; Muñoz, P; Sánchez-Carrillo, C, 2018
)
3.37
"Isavuconazole is a new triazole with an expanded-spectrum and potent activity against moulds and yeasts. "( Evaluation of isavuconazole MIC strips for susceptibility testing of Aspergillus and Scedosporium species.
Costanzo, CM; Oliveri, S; Palermo, CI; Scalia, G; Trovato, L, 2019
)
2.32
"Isavuconazole is a new antifungal prodrug for the treatment of invasive aspergillosis and mucormycosis. "( Isavuconazole Kinetic Exploration for Clinical Practice.
Concordet, D; Darnaud, L; Debard, A; Gandia, P; Godet, C; Lamoureux, F; Martins, P; Pontier, S; Venisse, N, 2018
)
3.37
"Isavuconazole (IVZ) is a newest generation triazole antifungal approved for the treatment of invasive aspergillosis (IA) in adult patients and for the treatment of invasive mucormycosis in adult patients for whom treatment with amphotericin B is inappropriate."( Isavuconazole: Case Report and Pharmacokinetic Considerations.
Girmenia, C; Goffredo, BM; Marchesi, F; Mengarelli, A; Menna, P; Minotti, G; Romano, A; Salvatorelli, E, 2018
)
2.64
"Isavuconazole is a new antifungal triazole agent with excellent oral bioavailability, predictable and linear pharmacokinetics, good tolerance and low adverse effects."( [Invasive aspergillosis in solid organ transplantation].
Aguado, JM; Silva, JT; Torre-Cisneros, J,
)
0.85
"Isavuconazole is a new azole, structurally related to fluconazole and voriconazole, that presents a very high oral absorption with no first-pass effect which is not interfered by the presence of food, gastric pH modifications, or mucositis. "( [Pharmacological profile of isavuconazole].
Azanza Perea, JR; Sádaba Díaz de Rada, B,
)
1.87
"Isavuconazole is a broad-spectrum azole antifungal for the treatment of aspergillosis and mucormycosis."( Therapeutic drug concentrations of isavuconazole following the administration of isavuconazonium sulfate capsules via gastro-jejunum tube: A case report.
Adamsick, ML; Elshaboury, RH; Gandhi, RG; Gift, T; Kotton, CN; Mansour, MK, 2019
)
1.51
"Isavuconazole is a recent extended-spectrum triazole with activity against yeasts. "( Isavuconazole MIC distribution of 29 yeast species responsible for invasive infections (2015-2017).
Boullié, A; Bretagne, S; Desnos-Ollivier, M; Dromer, F; Gautier, C; Lortholary, O, 2019
)
3.4
"Isavuconazole (ISA) is an attractive candidate for primary mold-active prophylaxis in high-risk patients with hematologic malignancies or hematopoietic cell transplant (HCT) recipients. "( Isavuconazole Prophylaxis in Patients With Hematologic Malignancies and Hematopoietic Cell Transplant Recipients.
Fontana, L; Hakki, M; Lewis, JS; Noble, BN; Perlin, DS; Strasfeld, L; Zhao, Y, 2020
)
3.44
"Isavuconazole is a new broad-spectrum triazole with a favorable pharmacokinetic and safety profile. "( In vitro activities of isavuconazole and comparator antifungal agents tested against a global collection of opportunistic yeasts and molds.
Castanheira, M; Jones, RN; Messer, SA; Pfaller, MA; Rhomberg, PR, 2013
)
2.14
"Isavuconazole is an extended-spectrum triazole with in vitro activity against a wide variety of fungal pathogens. "( Isavuconazole activity against Aspergillus lentulus, Neosartorya udagawae, and Cryptococcus gattii, emerging fungal pathogens with reduced azole susceptibility.
Byrnes, E; Datta, K; Garcia-Effron, G; Marr, KA; Perlin, DS; Rhee, P; Staab, JF, 2013
)
3.28
"Isavuconazole is a novel expanded-spectrum triazole, which has recently been approved by the FDA as an orphan drug to treat invasive aspergillosis and is currently being studied in phase III clinical trials for invasive candidiasis. "( Determination of isavuconazole susceptibility of Aspergillus and Candida species by the EUCAST method.
Arendrup, MC; Cuenca-Estrella, M; Gomez-Lopez, A; Howard, SJ; Lass-Flörl, C, 2013
)
2.17
"Isavuconazole is a novel, broad-spectrum antifungal developed for the treatment of opportunistic fungal infections."( A phase 2, randomized, double-blind, multicenter trial to evaluate the safety and efficacy of three dosing regimens of isavuconazole compared with fluconazole in patients with uncomplicated esophageal candidiasis.
Azie, N; Ghannoum, M; Schmitt-Hoffmann, AH; Viljoen, J, 2015
)
1.35
"Isavuconazole is a novel broad-spectrum triazole antifungal agent. "( Safety and pharmacokinetics of isavuconazole as antifungal prophylaxis in acute myeloid leukemia patients with neutropenia: results of a phase 2, dose escalation study.
Böhme, A; Cornely, OA; Schmitt-Hoffmann, A; Ullmann, AJ, 2015
)
2.15
"Isavuconazole (ISA) is a new generation, broad-spectrum triazole that has a favorable spectrum of efficacy and is available in both intravenous and oral forms."( The 'cephalosporin era' of triazole therapy: isavuconazole, a welcomed newcomer for the treatment of invasive fungal infections.
Chitasombat, MN; Kontoyiannis, DP, 2015
)
1.4
"Isavuconazole is a new extended-spectrum triazole with activity against yeasts, molds, and dimorphic fungi. "( Isavuconazole: A New Broad-Spectrum Triazole Antifungal Agent.
Kauffman, CA; Miceli, MH, 2015
)
3.3
"Isavuconazole is a novel, broad-spectrum, antifungal azole. "( Activity of Isavuconazole and Other Azoles against Candida Clinical Isolates and Yeast Model Systems with Known Azole Resistance Mechanisms.
Coste, AT; Sanglard, D, 2016
)
2.26
"Isavuconazole is a novel triazole with broad-spectrum antifungal activity. "( Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial.
Aoun, M; Baddley, JW; Bow, EJ; Cornely, OA; Giladi, M; Heinz, WJ; Herbrecht, R; Hope, W; Karthaus, M; Kontoyiannis, DP; Lee, DG; Lee, M; Lortholary, O; Maertens, JA; Maher, RM; Marr, KA; Morrison, VA; Neofytos, D; Oren, I; Patterson, TF; Raad, II; Rahav, G; Schmitt-Hoffmann, AH; Selleslag, D; Shoham, S; Thompson, GR; Ullmann, AJ; Zeiher, B, 2016
)
3.32
"Isavuconazole is a new azole antifungal drug with a broad antifungal spectrum that includes yeasts, molds and dimorphic fungi. "( Isavuconazonium sulfate for the treatment of fungal infection.
Temesgen, Z; Walker, RC; Zeuli, JD, 2016
)
1.88
"Isavuconazole is a triazole active in vitro and in animal models against moulds of the order Mucorales."( Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis.
Alangaden, GJ; Brown, JM; Chetchotisakd, P; Cornely, OA; Engelhardt, M; Fredricks, DN; Heinz, WJ; Herbrecht, R; Ito, M; Jaruratanasirikul, S; Kanj, SS; Kaufhold, A; Klimko, N; Klyasova, G; Lee, M; Maertens, JA; Maher, RM; Marty, FM; Melinkeri, SR; Mullane, KM; Oren, I; Ostrosky-Zeichner, L; Pappas, PG; Perfect, JR; Ráčil, Z; Rahav, G; Santos, R; Sasse, C; Schwartz, S; Thompson, GR; Vehreschild, JJ; Vehreschild, MJGT; Young, JH; Zeiher, B, 2016
)
2.6
"Isavuconazole (ISAV) is a novel, broad-spectrum, triazole antifungal agent (IV and by mouth [PO]) developed for the treatment of IFD."( Isavuconazole Treatment of Cryptococcosis and Dimorphic Mycoses.
Azie, N; Cornely, OA; Engelhardt, M; Kovanda, L; Lee, M; Maher, R; Ostrosky-Zeichner, L; Perfect, JR; Queiroz-Telles, F; Rendon, A; Ribeiro Dos Santos, R; Thompson, GR; Vazquez, JA, 2016
)
2.6
"Isavuconazole is a triazole currently approved not only for use in invasive aspergillosis and mucormycosis but also has demonstrable activity against Candida species and other common fungal pathogens. "( Isavuconazonium sulfate: a triazole prodrug for invasive fungal infections.
Bossaer, JB; Carico, R; Cluck, D; Harirforoosh, S; Murrell, D, 2017
)
1.9
"Isavuconazole is a new triazole with broad-spectrum antifungal activity including invasive aspergillosis and mucormycosis."( Isavuconazonium sulfate: a triazole prodrug for invasive fungal infections.
Bossaer, JB; Carico, R; Cluck, D; Harirforoosh, S; Murrell, D, 2017
)
1.9
"Isavuconazole is a second-generation triazole with activity against a broad spectrum of clinically important fungi. "( Isavuconazole: A Review in Invasive Aspergillosis and Mucormycosis.
Scott, LJ; Shirley, M, 2016
)
3.32
"Isavuconazole is a cost-effective option for the treatment of IA among hospitalized patients."( Cost-Effectiveness Analysis of Isavuconazole vs. Voriconazole as First-Line Treatment for Invasive Aspergillosis.
Azie, N; Harrington, R; Lee, E; Messali, A; Spalding, J; Wei, J; Wu, EQ; Yang, H, 2017
)
2.18
"Isavuconazole (ISAV) is a new mucormycosis treatment."( The cost of treating mucormycosis with isavuconazole compared with standard therapy in the UK.
Bagshaw, E; Blackney, M; Cornely, OA; Escrig, C; Heimann, SM; Kuessner, D; Posthumus, J, 2017
)
1.45
"Isavuconazole (BAL4815) is a promising novel broad-spectrum triazole in late-stage clinical development that has proven to be active in vitro against Aspergillus, Candida and Cryptococcus neoformans, the most common agents of IFIs."( Isavuconazole: a new and promising antifungal triazole for the treatment of invasive fungal infections.
Bouza, E; Guinea, J, 2008
)
2.51
"Isavuconazole is a welcome addition to the growing antifungal armamentarium with potent in vitro activity against emerging yeast pathogens. "( In vitro activity of isavuconazole against Trichosporon, Rhodotorula, Geotrichum, Saccharomyces and Pichia species.
Fothergill, A; Patterson, TF; Sutton, DA; Thompson, GR; Wiederhold, NP, 2009
)
2.11
"Isavuconazole is a novel, water soluble, broad-spectrum azole in clinical development for the treatment of invasive aspergillosis and candidiasis."( In vitro antifungal activity of isavuconazole against 345 mucorales isolates collected at study centers in eight countries.
Ghannoum, MA; González, GM; Guinea, J; Heep, M; Lass-Flörl, C; Verweij, PE; Warn, P; Wiedrhold, NP, 2009
)
1.36
"Isavuconazole is a promising new antifungal drug with favorable pharmacokinetic properties and excellent activity against a number of fungi. "( Effect of mild and moderate liver disease on the pharmacokinetics of isavuconazole after intravenous and oral administration of a single dose of the prodrug BAL8557.
Edwards, DJ; Heep, M; Peterfaí, E; Roos, B; Schmitt-Hoffmann, A; Spickermann, J; Stoeckel, K, 2009
)
2.03
"Isavuconazole is a new triazole currently undergoing phase III clinical trials. "( Isavuconazole: a comprehensive review of spectrum of activity of a new triazole.
Thompson, GR; Wiederhold, NP, 2010
)
3.25
"Isavuconazole is a novel second-generation triazole with broad-spectrum antifungal activity, and a favorable pharmacokinetic-pharmacodynamic profile."( Evaluation of the pharmacokinetics and clinical utility of isavuconazole for treatment of invasive fungal infections.
Hope, W; Livermore, J, 2012
)
1.34

Effects

Isavuconazole has a favorable pharmacokinetic and safety profile compared to other azole antifungal agents. Its high protein binding and lipophilicity raise concerns about drug sequestration in the VV-ECMO circuit.

ExcerptReferenceRelevance
"Isavuconazole has a favorable pharmacokinetic and safety profile compared to other azole antifungal agents, but its high protein binding and lipophilicity raise concerns about drug sequestration in the VV-ECMO circuit."( Decreased isavuconazole trough concentrations in the treatment of invasive aspergillosis in an adult patient receiving extracorporeal membrane oxygenation support.
Kludjian, G; Miller, M; Mohrien, K; Morita, K, 2022
)
1.85
"Isavuconazole (ISA) has a similar broad spectrum of activity to PCZ; however, real-world data regarding the tolerability of ISA after PCZ toxicity are lacking."( Tolerability of isavuconazole after posaconazole toxicity in leukaemia patients.
DiPippo, AJ; Kontoyiannis, DP; Rausch, CR, 2019
)
1.58
"Isavuconazole has a broad spectrum of activity and favorable pharmacokinetic properties, providing an advantage over other currently available broad-spectrum azole antifungals and a clinically useful alternative to voriconazole for the treatment of invasive aspergillosis. "( Isavuconazole: A New Option for the Management of Invasive Fungal Infections.
Carver, PL; Pettit, NN, 2015
)
3.3

Actions

ExcerptReferenceRelevance
"Isavuconazole displays broad anti-mould activity. "( Revision of EUCAST breakpoints: consequences for susceptibility of contemporary Danish mould isolates to isavuconazole and comparators.
Arendrup, MC; Guinea, J; Hare, RK; Jørgensen, KM; Meletiadis, J, 2020
)
2.21

Treatment

Isavuconazole treatment was initiated with the standard maintenance dose of 200 mg daily. Survival and tissue fungal burden serving as primary and secondary endpoints.

ExcerptReferenceRelevance
"Isavuconazole treatment was initiated with the standard maintenance dose of 200 mg daily."( Successful and Safe Real-Time TDM-Guided Treatment of Invasive Pulmonary and Cerebral Aspergillosis Using Low-Dose Isavuconazole in a Patient with Primary Biliary Cirrhosis: Grand Round/A Case Study.
Cojutti, PG; Giannella, M; Pea, F; Rinaldi, M; Viale, P, 2023
)
1.84
"Isavuconazole-treated subjects received 372 mg of isavuconazonium sulphate (corresponding to 200 mg of isavuconazole) three times daily for 2 days, then once daily. "( Variability and exposure-response relationships of isavuconazole plasma concentrations in the Phase 3 SECURE trial of patients with invasive mould diseases.
Andes, D; Engelhardt, M; Groll, AH; Kaindl, T; Larger, P; Saulay, M, 2019
)
2.21
"Treatment with isavuconazole (orally), micafungin (intraperitoneally), a combination of both or LAmB (intravenously) was compared, with survival and tissue fungal burden serving as primary and secondary endpoints, respectively."( Monotherapy or combination therapy of isavuconazole and micafungin for treating murine mucormycosis.
Alqarihi, A; Azie, N; Edwards, JE; Gebremariam, T; Ibrahim, AS; Uppuluri, P; Wiederhold, NP, 2017
)
1.07

Toxicity

Isavuconazole was not inferior to other antifungal agents for the treatment and prophylaxis of IFIs, with substantially fewer drug-associated adverse events and discontinuations. Adverse events were significantly higher in CPA patients commenced on voriconazole.

ExcerptReferenceRelevance
" All doses were well tolerated, and no severe or serious adverse events occurred."( Single-ascending-dose pharmacokinetics and safety of the novel broad-spectrum antifungal triazole BAL4815 after intravenous infusions (50, 100, and 200 milligrams) and oral administrations (100, 200, and 400 milligrams) of its prodrug, BAL8557, in healthy
Beglinger, C; Brown, T; Heep, M; Roehrle, M; Roos, B; Schleimer, M; Schmitt-Hoffmann, A; Weidekamm, E, 2006
)
0.33
" All adverse events reported were mild or moderate, except one severe rhinitis event which was not related to trial medication."( Multiple-dose pharmacokinetics and safety of the new antifungal triazole BAL4815 after intravenous infusion and oral administration of its prodrug, BAL8557, in healthy volunteers.
Brown, T; Heep, M; Maares, J; Roehrle, M; Roos, B; Schmitt-Hoffmann, A; Spickerman, J; Weidekamm, E, 2006
)
0.33
" The frequency of adverse events was similar in arm A (n = 22; 55%), arm B (n = 18; 45%), and arm D (n = 22; 58%), but higher in arm C (n = 29; 71%)."( A phase 2, randomized, double-blind, multicenter trial to evaluate the safety and efficacy of three dosing regimens of isavuconazole compared with fluconazole in patients with uncomplicated esophageal candidiasis.
Azie, N; Ghannoum, M; Schmitt-Hoffmann, AH; Viljoen, J, 2015
)
0.63
" The adverse events in five patients in the low-dose cohort and in eight patients in the high-dose cohort were considered to be drug related."( Safety and pharmacokinetics of isavuconazole as antifungal prophylaxis in acute myeloid leukemia patients with neutropenia: results of a phase 2, dose escalation study.
Böhme, A; Cornely, OA; Schmitt-Hoffmann, A; Ullmann, AJ, 2015
)
0.7
" Improvement in the management of IFDs have been achieved with the availability of new effective and safe antifungal drugs, however, many of these newer treatments have some limitations in their variable toxicity and unique predisposition for pharmacokinetic drug-drug interactions."( An update on the safety and interactions of antifungal drugs in stem cell transplant recipients.
Girmenia, C; Iori, AP, 2017
)
0.46
" All of these can cause significant adverse drug reactions."( Isavuconazole and voriconazole for the treatment of chronic pulmonary aspergillosis: A retrospective comparison of rates of adverse events.
Bongomin, F; Felton, T; Maguire, N; Moore, CB; Rautemaa-Richardson, R, 2019
)
1.96
" Adverse events were seen in 18 of 21 (86%) the patients in the voriconazole group and 12 of 20 (60%) in the isavuconazole group (P = 0."( Isavuconazole and voriconazole for the treatment of chronic pulmonary aspergillosis: A retrospective comparison of rates of adverse events.
Bongomin, F; Felton, T; Maguire, N; Moore, CB; Rautemaa-Richardson, R, 2019
)
2.17
"Compared with isavuconazole, adverse events were significantly higher in CPA patients commenced on voriconazole."( Isavuconazole and voriconazole for the treatment of chronic pulmonary aspergillosis: A retrospective comparison of rates of adverse events.
Bongomin, F; Felton, T; Maguire, N; Moore, CB; Rautemaa-Richardson, R, 2019
)
2.32
"ISA is safe in pediatric patients for the treatment of IFI."( Safety of Isavuconazonium Sulfate in Pediatrics Patients With Hematologic Malignancies and Hematopoietic Cell Transplantation With Invasive Fungal Infections: A Real World Experience.
Chen, J; Dadwal, S; Karras, NA; Pawlowska, A; Rosenthal, J; Ross, JA; Sun, W; Tegtmeier, B; Yamada, C; Zaia, J, 2020
)
0.56
"Voriconazole is frequently discontinued prematurely as primary antifungal prophylaxis (AFP) in allogeneic hematopoietic cell transplant (HCT) recipients due to adverse events."( Efficacy and safety of isavuconazole compared with voriconazole as primary antifungal prophylaxis in allogeneic hematopoietic cell transplant recipients.
Bogler, Y; Lee, YJ; Neofytos, D; Papanicolaou, GA; Perales, MA; Seo, SK; Shaffer, B; Stern, A; Su, Y, 2021
)
0.93
" Antifungal management is challenging due to diagnostic delay, adverse drug reactions, drug-drug interactions, narrow therapeutic window, and the emergence of resistance."( Efficacy and safety of Isavuconazole for the treatment of invasive
Chandrasekar, PH; Sivasubramanian, G, 2022
)
1.03
" It offers several advantages over other antifungal agents, including having a better adverse event profile with respect to hepatotoxicity, neuro-visual toxicity, QTc prolongation, as well as a stable pharmacokinetic profile obviating the need for therapeutic drug monitoring."( Efficacy and safety of Isavuconazole for the treatment of invasive
Chandrasekar, PH; Sivasubramanian, G, 2022
)
1.03
" Mild gamma-glutamyltransferase elevation was the most frequent adverse event (34%)."( Safety and Effectiveness of Isavuconazole Treatment for Fungal Infections in Solid Organ Transplant Recipients (ISASOT Study).
Berastegui, C; Bravo, C; Campany-Herrero, D; Castells, L; Deu, M; Gavaldà, J; Len, O; Los-Arcos, I; Márquez-Algaba, E; Martín-Gómez, MT; Monforte, A; Moreso, F; Nuvials, X; Sacanell, J; Sempere, A, 2022
)
1.02
" There were no serious adverse events, and all reported treatment-emergent adverse events were of mild intensity."( Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Isavuconazonium Sulfate in Healthy Adult Japanese Subjects.
Kumagai, Y; Ose, A; Shirae, S, 2022
)
0.72
" In the safety evaluation, the incidence of adverse events in participants with chronic pulmonary aspergillosis was similar in both groups."( Efficacy and safety of isavuconazole against deep-seated mycoses: A phase 3, randomized, open-label study in Japan.
Akashi, K; Izumikawa, K; Kakeya, H; Kamei, K; Kanda, Y; Kimura, SI; Kishida, M; Kohno, S; Matsuda, M; Miyazaki, T; Miyazaki, Y; Mukae, H; Niki, Y; Ogawa, K; Okada, F; Suzuki, J; Takazono, T; Taniguchi, S; Tateda, K; Yoshida, M, 2023
)
1.22
" Safety outcomes included the rates of treatment-emergent adverse events and premature isavuconazole discontinuation."( Isavuconazole for the Treatment of Invasive Mold Disease in Solid Organ Transplant Recipients: A Multicenter Study on Efficacy and Safety in Real-life Clinical Practice.
Aguado, JM; Bodro, M; Carratalà, J; Cordero, E; Fariñas, MDC; Fernández-Ruiz, M; Fortún, J; Goikoetxea, J; Gutiérrez Martín, I; Illaro, A; López-Viñau, T; Moreno, A; Muñoz, P; Ramos-Martínez, A; Rodriguez-Álvarez, R; Ruiz-Ruigómez, M; Sabé, N; Salto-Alejandre, S; Valerio, M; Vidal, E, 2023
)
2.58
" At least 1 treatment-emergent adverse event occurred in 17."( Isavuconazole for the Treatment of Invasive Mold Disease in Solid Organ Transplant Recipients: A Multicenter Study on Efficacy and Safety in Real-life Clinical Practice.
Aguado, JM; Bodro, M; Carratalà, J; Cordero, E; Fariñas, MDC; Fernández-Ruiz, M; Fortún, J; Goikoetxea, J; Gutiérrez Martín, I; Illaro, A; López-Viñau, T; Moreno, A; Muñoz, P; Ramos-Martínez, A; Rodriguez-Álvarez, R; Ruiz-Ruigómez, M; Sabé, N; Salto-Alejandre, S; Valerio, M; Vidal, E, 2023
)
2.35
"Isavuconazole is a safe therapeutic option for IMD in SOT recipients, with efficacy comparable to other patient groups."( Isavuconazole for the Treatment of Invasive Mold Disease in Solid Organ Transplant Recipients: A Multicenter Study on Efficacy and Safety in Real-life Clinical Practice.
Aguado, JM; Bodro, M; Carratalà, J; Cordero, E; Fariñas, MDC; Fernández-Ruiz, M; Fortún, J; Goikoetxea, J; Gutiérrez Martín, I; Illaro, A; López-Viñau, T; Moreno, A; Muñoz, P; Ramos-Martínez, A; Rodriguez-Álvarez, R; Ruiz-Ruigómez, M; Sabé, N; Salto-Alejandre, S; Valerio, M; Vidal, E, 2023
)
3.8
"TDM-guided clinical pharmacological advice was essential for the successful and safe management of isavuconazole treatment in this patient with moderate liver dysfunction."( Successful and Safe Real-Time TDM-Guided Treatment of Invasive Pulmonary and Cerebral Aspergillosis Using Low-Dose Isavuconazole in a Patient with Primary Biliary Cirrhosis: Grand Round/A Case Study.
Cojutti, PG; Giannella, M; Pea, F; Rinaldi, M; Viale, P, 2023
)
1.34
" Adverse events (AEs); all-cause mortality; and overall, clinical, mycological, and radiological response were assessed."( Post-hoc analysis of the safety and efficacy of isavuconazole in older patients with invasive fungal disease from the VITAL and SECURE studies.
Aram, JA; Engelhardt, M; Hamed, K; Huang, JJ; Kovanda, LL; Yan, J, 2023
)
1.17
" The discontinuation rate was defined as the percentage of therapy discontinuations due to adverse events."( A systematic review and meta-analysis of efficacy and safety of isavuconazole for the treatment and prophylaxis of invasive fungal infections.
Asai, N; Hagihara, M; Hirai, J; Iwamoto, T; Kato, H; Mikamo, H; Mori, N; Umemura, T; Yamagishi, Y, 2023
)
1.15
"Our meta-analysis revealed that isavuconazole was not inferior to other antifungal agents for the treatment and prophylaxis of IFIs, with substantially fewer drug-associated adverse events and discontinuations."( A systematic review and meta-analysis of efficacy and safety of isavuconazole for the treatment and prophylaxis of invasive fungal infections.
Asai, N; Hagihara, M; Hirai, J; Iwamoto, T; Kato, H; Mikamo, H; Mori, N; Umemura, T; Yamagishi, Y, 2023
)
1.43

Pharmacokinetics

This report summarizes phase 1 studies that evaluated pharmacokinetic interactions between the novel triazole antifungal agent isavuconazole and the immunosuppressants cyclosporine, mycophenolic acid, prednisolone, sirolimus, and tacrolimus in healthy adults. The objective of this analysis was to develop a population pharmacokinetics (PPK) model.

ExcerptReferenceRelevance
" AUC values reflected a fourfold to fivefold accumulation of active drug in plasma during once-daily dosing, which is in line with the long elimination half-life of BAL4815 determined after the last administration (mean, 84."( Multiple-dose pharmacokinetics and safety of the new antifungal triazole BAL4815 after intravenous infusion and oral administration of its prodrug, BAL8557, in healthy volunteers.
Brown, T; Heep, M; Maares, J; Roehrle, M; Roos, B; Schmitt-Hoffmann, A; Spickerman, J; Weidekamm, E, 2006
)
0.33
" The pharmacodynamic parameter that optimally links drug exposure with the antifungal effect was determined using dose fractionation studies."( Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
Denning, DW; Hope, WW; Majithiya, J; Parmar, A; Sharp, A; Warn, PA, 2009
)
0.6
"Isavuconazole is a promising new antifungal drug with favorable pharmacokinetic properties and excellent activity against a number of fungi."( Effect of mild and moderate liver disease on the pharmacokinetics of isavuconazole after intravenous and oral administration of a single dose of the prodrug BAL8557.
Edwards, DJ; Heep, M; Peterfaí, E; Roos, B; Schmitt-Hoffmann, A; Spickermann, J; Stoeckel, K, 2009
)
2.03
"Isavuconazole has the potential to become an important agent for the treatment of invasive fungal infections, principally because of its relatively broad and potent in vitro antifungal activity, and its favorable pharmacokinetic profile."( Evaluation of the pharmacokinetics and clinical utility of isavuconazole for treatment of invasive fungal infections.
Hope, W; Livermore, J, 2012
)
2.06
" They have consistently shown that the pharmacodynamic index most closely correlated with efficacy is the ratio of the 24-h area under the concentration-time curve (AUC) to the MIC, and a target 24-h free-drug AUC/MIC ratio near 25 is associated with 50% of maximal microbiologic efficacy."( Isavuconazole pharmacodynamic target determination for Candida species in an in vivo murine disseminated candidiasis model.
Andes, DR; Diekema, D; Lepak, AJ; Marchillo, K; VanHecker, J, 2013
)
1.83
" One strategy used to optimize outcomes is antifungal pharmacodynamic (PD) examination."( Isavuconazole (BAL4815) pharmacodynamic target determination in an in vivo murine model of invasive pulmonary aspergillosis against wild-type and cyp51 mutant isolates of Aspergillus fumigatus.
Andes, DR; Lepak, AJ; Marchillo, K; Vanhecker, J, 2013
)
1.83
" Although previously available second-generation triazole antifungals have significantly expanded the spectrum of the triazole antifungal class, these agents are laden with shortcomings in their safety profiles as well as formulation and pharmacokinetic challenges."( Isavuconazole: Pharmacology, Pharmacodynamics, and Current Clinical Experience with a New Triazole Antifungal Agent.
Marx, KR; Nishimoto, AT; Rogers, PD; Rybak, JM, 2015
)
1.86
" Bridging to humans using population pharmacokinetic (PK) data from a clinical trial in invasive aspergillosis was performed using Monte Carlo simulations."( Pharmacodynamics of isavuconazole in experimental invasive pulmonary aspergillosis: implications for clinical breakpoints.
Bonate, P; Desai, A; Hope, WW; Kovanda, LL; Petraitiene, R; Petraitis, V; Walsh, TJ, 2016
)
0.76
" A population pharmacokinetic (PPK) model was constructed using nonparametric estimation to compare the pharmacokinetic (PK) behaviors of isavuconazole in patients treated in the phase 3 VITAL open-label clinical trial, which evaluated the efficacy and safety of the drug for treatment of renally impaired IA patients and patients with invasive fungal disease (IFD) caused by emerging molds, yeasts, and dimorphic fungi."( Isavuconazole Population Pharmacokinetic Analysis Using Nonparametric Estimation in Patients with Invasive Fungal Disease (Results from the VITAL Study).
Akhtar, S; Bonate, P; Desai, AV; Hope, WW; Kovanda, LL; Lu, Q; Townsend, RW, 2016
)
2.08
"This report summarizes phase 1 studies that evaluated pharmacokinetic interactions between the novel triazole antifungal agent isavuconazole and the immunosuppressants cyclosporine, mycophenolic acid, prednisolone, sirolimus, and tacrolimus in healthy adults."( Pharmacokinetic Assessment of Drug-Drug Interactions of Isavuconazole With the Immunosuppressants Cyclosporine, Mycophenolic Acid, Prednisolone, Sirolimus, and Tacrolimus in Healthy Adults.
Akhtar, S; Desai, A; Groll, AH; Han, D; Howieson, C; Kato, K; Kowalski, D; Lademacher, C; Lewis, W; Mandarino, D; Pearlman, H; Townsend, R; Yamazaki, T, 2017
)
0.91
"This phase 1 trial evaluated pharmacokinetic and pharmacodynamic interactions between the novel triazole antifungal agent isavuconazole and warfarin in healthy adults."( Pharmacokinetic and Pharmacodynamic Evaluation of the Drug-Drug Interaction Between Isavuconazole and Warfarin in Healthy Subjects.
Akhtar, S; Desai, A; Dietz, AJ; Kowalski, D; Lademacher, C; Pearlman, H; Townsend, R; Yamazaki, T, 2017
)
0.89
" The objective of this analysis was to develop a population pharmacokinetic (PPK) model to identify covariates that affect isavuconazole pharmacokinetics and to determine the probability of target attainment (PTA) for invasive aspergillosis patients."( Population Pharmacokinetics of Isavuconazole from Phase 1 and Phase 3 (SECURE) Trials in Adults and Target Attainment in Patients with Invasive Infections Due to Aspergillus and Other Filamentous Fungi.
Bonate, PL; Desai, A; Kovanda, L; Kowalski, D; Lu, Q; Townsend, R, 2016
)
0.93
"Therapeutic drug monitoring (TDM) may be required to achieve optimal clinical outcomes in the setting of significant pharmacokinetic variability, a situation that applies to a number of anti-mould therapies."( Therapeutic drug monitoring for invasive mould infections and disease: pharmacokinetic and pharmacodynamic considerations.
Hope, WW; Stott, KE, 2017
)
0.46
" This review aims to summarize and evaluate the published literature reporting clinical pharmacokinetic and pharmacodynamic outcome data of isavuconazole in humans."( A Review of the Clinical Pharmacokinetics and Pharmacodynamics of Isavuconazole.
Wilby, KJ, 2018
)
0.92
" Data regarding the pharmacokinetic profile of isavuconazole in patients with CF undergoing lung transplantation are currently not available."( Isavuconazole pharmacokinetics in a patient with cystic fibrosis following bilateral orthotopic lung transplantation.
Kabulski, GM; MacVane, SH, 2018
)
2.18
" Monte Carlo simulations were conducted using pharmacokinetic (PK) parameters and pharmacodynamics (PD) data to determine the probabilities of target attainment and cumulative fractions of response in terms of area under the concentration curve/minimum inhibition concentration (AUC/MIC) targets of isavuconazole."( Pharmacokinetic/Pharmacodynamic Analysis of Isavuconazole Against Aspergillus spp. and Candida spp. in Healthy Subjects and Patients With Hepatic or Renal Impairment by Monte Carlo Simulation.
Ding, H; Fang, L; Huang, P; Sun, J; Tong, Y; Xu, G; Zhang, Y; Zheng, X; Zhu, L, 2018
)
0.92
" However, VCZ and PCZ are liable for drug-drug interactions and show a pharmacokinetic variability that requires therapeutic drug monitoring (TDM)."( Isavuconazole: Case Report and Pharmacokinetic Considerations.
Girmenia, C; Goffredo, BM; Marchesi, F; Mengarelli, A; Menna, P; Minotti, G; Romano, A; Salvatorelli, E, 2018
)
1.92
" Pharmacokinetic (PK) samples were collected predose through day 21."( Pharmacokinetics and Bioequivalence of Isavuconazole Administered as Isavuconazonium Sulfate Intravenous Solution via Nasogastric Tube or Orally in Healthy Subjects.
Desai, A; Goldwater, R; Helmick, M; Heo, N; Martin, N; Moy, S; Stanhope, S, 2021
)
0.89
"8 hours after PO administration with an elimination rate half-life of 66."( Pharmacokinetics of isavuconazole in healthy cats after oral and intravenous administration.
Dear, JD; Wittenburg, LA; Woerde, DJ, 2022
)
1.04
"Maximum a posteriori Bayesian estimation (MAP-BE) based on a limited sampling strategy and a population pharmacokinetic (POPPK) model is used to estimate individual pharmacokinetic parameters."( A Hybrid Algorithm Combining Population Pharmacokinetic and Machine Learning for Isavuconazole Exposure Prediction.
Destere, A; Drici, MD; Labriffe, M; Marquet, P; Woillard, JB, 2023
)
1.14
" This study aims to investigate the potential pharmacokinetic interactions between lenvatinib and various azoles (ketoconazole, voriconazole, isavuconazole and posaconazole) when orally administered to rats."( Evaluation of the inhibitory effect of azoles on pharmacokinetics of lenvatinib in rats both in vivo and in vitro by UPLC-MS/MS.
Geng, P; Han, A; Lu, Z; Song, X; Wang, S; Wang, Y; Wu, Q; Xia, M; Zhou, Q; Zhou, Y, 2023
)
1.11
" Total and unbound isavuconazole pharmacokinetics were analysed by means of population pharmacokinetic modelling using NONMEM."( Population Pharmacokinetics of Total and Unbound Isavuconazole in Critically Ill Patients: Implications for Adaptive Dosing Strategies.
Brüggemann, RJM; Debaveye, Y; Jansen, AME; Mertens, B; Schouten, J; Spriet, I; Ter Heine, R; Verweij, PE; Wauters, J, 2023
)
1.49
" This highly variable protein binding asks for re-evaluation of current pharmacokinetic and pharmacodynamic targets for isavuconazole."( High Variability in Isavuconazole Unbound Fraction in Clinical Practice: A Call to Reconsider Pharmacokinetic/Pharmacodynamic Targets and Breakpoints.
Brüggemann, RJM; Jansen, AME; Ter Heine, R; Verweij, PE, 2023
)
1.44
" At least one pharmacokinetic curve was assessed."( Pharmacokinetic investigations of isavuconazole in paediatric cancer patients show reduced exposure of isavuconazole after opening capsules for administration via a nasogastric tube.
Brüggemann, RJM; Bury, D; Muilwijk, EW; Ter Heine, R; Tissing, WJE; van der Elst, KCM; Wolfs, TFW, 2023
)
1.19

Compound-Compound Interactions

ExcerptReferenceRelevance
"A paucity of data currently exists regarding drug-drug interaction (DDI) with tacrolimus and isavuconazole coadministration."( Drug-Drug Interaction Between Isavuconazole and Tacrolimus: Is Empiric Dose Adjustment Necessary?
Alexander, MD; Armistead, PM; Daniels, LM; Kufel, WD; Ptachcinski, JR; Shaw, JR, 2020
)
1.07

Bioavailability

The most relevant pharmacokinetics features are water-solubility of the prodrug. The absolute bioavailability of isavuconazole was 41. It has an extensive penetration into most tissues.

ExcerptReferenceRelevance
" Based on the exposure data, oral bioavailability of BAL4815 is assumed to be very high."( Single-ascending-dose pharmacokinetics and safety of the novel broad-spectrum antifungal triazole BAL4815 after intravenous infusions (50, 100, and 200 milligrams) and oral administrations (100, 200, and 400 milligrams) of its prodrug, BAL8557, in healthy
Beglinger, C; Brown, T; Heep, M; Roehrle, M; Roos, B; Schleimer, M; Schmitt-Hoffmann, A; Weidekamm, E, 2006
)
0.33
" Based on AUC values after oral and intravenous administration, an excellent oral bioavailability can be predicted for BAL4815."( Multiple-dose pharmacokinetics and safety of the new antifungal triazole BAL4815 after intravenous infusion and oral administration of its prodrug, BAL8557, in healthy volunteers.
Brown, T; Heep, M; Maares, J; Roehrle, M; Roos, B; Schmitt-Hoffmann, A; Spickerman, J; Weidekamm, E, 2006
)
0.33
" Reduced toxicity, enhancement of bioavailability and counteraction of resistance are features desired by clinicians."( Newer antifungal agents.
Türel, O, 2011
)
0.37
" Characteristics include linear dose-proportional pharmacokinetics, intravenous and oral formulations allowing therapeutic streamlining, once daily dosing, absence of nephrotoxic solubilizing agents and excellent oral bioavailability independent of prandial status and gastric acidity."( Isavuconazole: a new extended spectrum triazole for invasive mold diseases.
Ananda-Rajah, MR; Kontoyiannis, D, 2015
)
1.86
" Advantages of this triazole include the availability of a water-soluble intravenous formulation, excellent bioavailability of the oral formulation, and predictable pharmacokinetics in adults."( Isavuconazole: A New Broad-Spectrum Triazole Antifungal Agent.
Kauffman, CA; Miceli, MH, 2015
)
1.86
" These characteristics, in an agent available in both a highly bioavailable oral and a β-cyclodextrin-free intravenous formulation, will likely make isavuconazole a welcome addition to the triazole class of antifungals."( Isavuconazole: Pharmacology, Pharmacodynamics, and Current Clinical Experience with a New Triazole Antifungal Agent.
Marx, KR; Nishimoto, AT; Rogers, PD; Rybak, JM, 2015
)
2.06
"Two openlabel, single-dose, randomized crossover studies and one open-label, multiple-dose, parallel group study in healthy volunteers were conducted with the prodrug, isavuconazonium sulfate, to determine absolute bioavailability of the active triazole, isavuconazole (EudraCT 2007-004949-15; n = 14), and the effect of food (EudraCT 2007- 004940-63; n = 26), and pH (NCT02128893; n = 24) on the absorption of isavuconazole."( Isavuconazole absorption following oral administration in healthy subjects is comparable to intravenous dosing, and is not affected by food, or drugs that alter stomach pH.
Desai, A; Kowalski, D; Pearlman, H; Schmitt-Hoffmann, A; Townsend, R; Yamazaki, T, 2016
)
2.06
" Mucositis was reported by site investigators and its impact on oral bioavailability was assessed."( Impact of Mucositis on Absorption and Systemic Drug Exposure of Isavuconazole.
Desai, AV; Engelhardt, M; Hope, WW; Kovanda, LL; Lademacher, C; Lu, Q; Maertens, J; Marty, FM, 2017
)
0.69
" The most relevant pharmacokinetics features are water-solubility of the prodrug, rapid cleavage of the prodrug into active moiety and cleavage product by plasmatic esterases, high oral bioavailability of isavuconazole with an extensive penetration into most tissues and a good safety profile even in case of renal impairment."( Isavuconazole: A new broad-spectrum azole. Part 2: pharmacokinetics and clinical activity.
Denis, J; Herbrecht, R; Ledoux, MP; Nivoix, Y, 2018
)
2.11
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" Oral bioavailability was estimated to be approximately 88%."( Pharmacokinetics of isavuconazole in healthy cats after oral and intravenous administration.
Dear, JD; Wittenburg, LA; Woerde, DJ, 2022
)
1.04
" The absolute bioavailability of isavuconazole was 41."( Pharmacokinetic investigations of isavuconazole in paediatric cancer patients show reduced exposure of isavuconazole after opening capsules for administration via a nasogastric tube.
Brüggemann, RJM; Bury, D; Muilwijk, EW; Ter Heine, R; Tissing, WJE; van der Elst, KCM; Wolfs, TFW, 2023
)
1.47
"This study revealed low bioavailability after nasogastric tube administration with opened capsules."( Pharmacokinetic investigations of isavuconazole in paediatric cancer patients show reduced exposure of isavuconazole after opening capsules for administration via a nasogastric tube.
Brüggemann, RJM; Bury, D; Muilwijk, EW; Ter Heine, R; Tissing, WJE; van der Elst, KCM; Wolfs, TFW, 2023
)
1.19

Dosage Studied

We aimed to describe the total and unbound isavuconazole pharmacokinetics and subsequently propose a dosage optimisation strategy. The objectives of this analysis were to develop a population PK model for Japanese patients with deep-seated mycoses and healthy subjects.

ExcerptRelevanceReference
" Once-daily oral dosing of 50- or 100-mg equivalents of BAL8557 were recently demonstrated to be efficacious in a phase 2 study conducted with patients with esophageal candidiasis."( Multiple-dose pharmacokinetics and safety of the new antifungal triazole BAL4815 after intravenous infusion and oral administration of its prodrug, BAL8557, in healthy volunteers.
Brown, T; Heep, M; Maares, J; Roehrle, M; Roos, B; Schmitt-Hoffmann, A; Spickerman, J; Weidekamm, E, 2006
)
0.33
"The aim of this study was to assess the dose-response of isavuconazole, voriconazole and fluconazole in disseminated Candida tropicalis and Candida krusei infections."( Efficacy of isavuconazole, voriconazole and fluconazole in temporarily neutropenic murine models of disseminated Candida tropicalis and Candida krusei.
Denning, DW; Majithiya, J; Parmar, A; Sharp, A; Warn, PA, 2009
)
0.98
" This phase 2 trial compared the efficacy and safety of three oral dosing regimens of isavuconazole with an oral fluconazole regimen in the primary treatment of uncomplicated esophageal candidiasis."( A phase 2, randomized, double-blind, multicenter trial to evaluate the safety and efficacy of three dosing regimens of isavuconazole compared with fluconazole in patients with uncomplicated esophageal candidiasis.
Azie, N; Ghannoum, M; Schmitt-Hoffmann, AH; Viljoen, J, 2015
)
0.85
" The patients in the low-dose cohort (n = 11) received isavuconazole loading doses on day 1 (400/200/200 mg, 6 h apart) and day 2 (200/200 mg, 12 h apart), followed by once-daily maintenance dosing (200 mg) on days 3 to 28."( Safety and pharmacokinetics of isavuconazole as antifungal prophylaxis in acute myeloid leukemia patients with neutropenia: results of a phase 2, dose escalation study.
Böhme, A; Cornely, OA; Schmitt-Hoffmann, A; Ullmann, AJ, 2015
)
0.95
" Based on currently available data, some antifungals should be dosed based on total body weight (i."( Dosing of antifungal agents in obese people.
Hall, RG; Payne, KD, 2016
)
0.43
" It is available in both oral and intravenous formulations for once-a-day dosing and has favorable safety profile and drug interaction potential in comparison to voriconazole."( Isavuconazonium sulfate for the treatment of fungal infection.
Temesgen, Z; Walker, RC; Zeuli, JD, 2016
)
0.43
" Simulations were performed to describe the MICs covered by the clinical dosing regimen."( Isavuconazole Population Pharmacokinetic Analysis Using Nonparametric Estimation in Patients with Invasive Fungal Disease (Results from the VITAL Study).
Akhtar, S; Bonate, P; Desai, AV; Hope, WW; Kovanda, LL; Lu, Q; Townsend, RW, 2016
)
1.88
") for 2 days, followed by a single daily oral dose for 3 days, in the presence of steady state esomeprazole dosed orally at 40 mg/day."( Isavuconazole absorption following oral administration in healthy subjects is comparable to intravenous dosing, and is not affected by food, or drugs that alter stomach pH.
Desai, A; Kowalski, D; Pearlman, H; Schmitt-Hoffmann, A; Townsend, R; Yamazaki, T, 2016
)
1.88
" The delivery of TDM as a future standard of care will require real-time measurement of drug concentrations at the bedside and algorithms for dosage adjustment."( Therapeutic drug monitoring for invasive mould infections and disease: pharmacokinetic and pharmacodynamic considerations.
Hope, WW; Stott, KE, 2017
)
0.46
" Two hundred thirty-one patients who received the clinical dosing regimen and had exposure parameters were included in the analysis."( Exposure-Response Relationships for Isavuconazole in Patients with Invasive Aspergillosis and Other Filamentous Fungi.
Andes, D; Bonate, PL; Desai, AV; Hope, WW; Kovanda, LL; Kowalski, DL; Mouton, JW; Mujais, S; Townsend, RW, 2017
)
0.73
" Using an in vivo estimation of the pharmacodynamic target and a previously published pharmacokinetic model, the probability of target attainment (PTA) was determined for a range of isavuconazole MICs using three dosing regimens (I, 200 mg once daily; II, 300 mg once daily; and III, 400 mg once daily)."( Isavuconazole susceptibility of clinical Aspergillus fumigatus isolates and feasibility of isavuconazole dose escalation to treat isolates with elevated MICs.
Brüggemann, RJM; Buil, JB; Meis, JF; Melchers, WJG; Mouton, JW; Verweij, PE; Wasmann, RE; Zoll, J, 2018
)
2.12
" The PTA for isolates with an isavuconazole MIC of 1 mg/L was 92%-99% for 90% effective concentration (EC90) for the three dosing regimens."( Isavuconazole susceptibility of clinical Aspergillus fumigatus isolates and feasibility of isavuconazole dose escalation to treat isolates with elevated MICs.
Brüggemann, RJM; Buil, JB; Meis, JF; Melchers, WJG; Mouton, JW; Verweij, PE; Wasmann, RE; Zoll, J, 2018
)
2.21
" Data from diseased patients confirmed these findings and also consistently demonstrated that regular dosing of isavuconazole results in achievement of concentrations and exposures that meet pharmacodynamic targets for therapeutic efficacy."( A Review of the Clinical Pharmacokinetics and Pharmacodynamics of Isavuconazole.
Wilby, KJ, 2018
)
0.93
"The aim of this pharmacokinetic/pharmacodynamic (PK/PD) study is to evaluate the efficacy of various isavuconazole dosing regimens for healthy individuals and patients with hepatic or renal impairment against Aspergillus spp."( Pharmacokinetic/Pharmacodynamic Analysis of Isavuconazole Against Aspergillus spp. and Candida spp. in Healthy Subjects and Patients With Hepatic or Renal Impairment by Monte Carlo Simulation.
Ding, H; Fang, L; Huang, P; Sun, J; Tong, Y; Xu, G; Zhang, Y; Zheng, X; Zhu, L, 2018
)
0.96
" For two of them, a drug dosage adjustment was proposed and applied by clinicians, together with a check for a new pharmacokinetic profile a few days later."( Isavuconazole Kinetic Exploration for Clinical Practice.
Concordet, D; Darnaud, L; Debard, A; Gandia, P; Godet, C; Lamoureux, F; Martins, P; Pontier, S; Venisse, N, 2018
)
1.92
"We determined isavuconazole serum concentrations for 150 UK patients receiving standard isavuconazole dosing regimens, including serial therapeutic drug monitoring for several patients on prolonged therapy."( Lessons from isavuconazole therapeutic drug monitoring at a United Kingdom Reference Center.
Borman, AM; Fraser, M; Hughes, JM; Johnson, EM; Noel, AR; Oliver, D; Sunderland, J, 2020
)
1.29
"Limited evidence concerning optimal azole dosing regimens currently exists for antifungal prophylaxis in hemato-oncological pediatric patients."( Real-World Comparison of Isavuconazole and Voriconazole in Terms of the Need for Dosage Adjustments Guided by Clinical Pharmacological Advice During Primary Prophylaxis of Invasive Fungal Infections in Pediatric Patients with Hemato-Oncological Malignanci
Belotti, T; Campoli, C; Cojutti, PG; Gatti, M; Masetti, R; Pea, F; Pession, A; Viale, P, 2022
)
1.02
" CPAs for isavuconazole and voriconazole and the number of dosage adjustments were collected."( Real-World Comparison of Isavuconazole and Voriconazole in Terms of the Need for Dosage Adjustments Guided by Clinical Pharmacological Advice During Primary Prophylaxis of Invasive Fungal Infections in Pediatric Patients with Hemato-Oncological Malignanci
Belotti, T; Campoli, C; Cojutti, PG; Gatti, M; Masetti, R; Pea, F; Pession, A; Viale, P, 2022
)
1.43
"Our findings suggest that there is limited variability in isavuconazole exposure in hemato-oncological pediatric patients receiving azole prophylaxis , resulting in a low need for CPA-guided dosage adjustments."( Real-World Comparison of Isavuconazole and Voriconazole in Terms of the Need for Dosage Adjustments Guided by Clinical Pharmacological Advice During Primary Prophylaxis of Invasive Fungal Infections in Pediatric Patients with Hemato-Oncological Malignanci
Belotti, T; Campoli, C; Cojutti, PG; Gatti, M; Masetti, R; Pea, F; Pession, A; Viale, P, 2022
)
1.27
"VV-ECMO is an increasingly utilized life support therapy for patients with cardiac and/or respiratory failure, but its impact on medication dosing is poorly understood."( Decreased isavuconazole trough concentrations in the treatment of invasive aspergillosis in an adult patient receiving extracorporeal membrane oxygenation support.
Kludjian, G; Miller, M; Mohrien, K; Morita, K, 2022
)
1.12
" The objectives of this analysis were to (1) develop a population PK model for Japanese patients with deep-seated mycoses and healthy subjects, and to identify significant covariates; (2) determine the probability of PK-pharmacodynamic (PK-PD) target attainment in Japanese patients by a clinical dosing regimen; and (3) evaluate the exposure-safety relationship of isavuconazole in Japanese patients."( Population Pharmacokinetics, Exposure-Safety, and Probability of Target Attainment Analyses for Isavuconazole in Japanese Patients With Deep-Seated Mycoses.
Kozaki, T; Mizuhata, J; Ose, A; Shirae, S; Tsuruya, Y, 2023
)
1.3
" Once assessed, the predictive performance of the model using simulations of different dosing and fungal susceptibility scenarios were conducted."( PK/PD modeling and simulation of the in vitro activity of the combinations of isavuconazole with echinocandins against Candida auris.
Caballero, U; Eraso, E; Jauregizar, N; Quindós, G; Schmidt, S; Vozmediano, V, 2023
)
1.14
" We aimed to describe the total and unbound isavuconazole pharmacokinetics and subsequently propose a dosage optimisation strategy."( Population Pharmacokinetics of Total and Unbound Isavuconazole in Critically Ill Patients: Implications for Adaptive Dosing Strategies.
Brüggemann, RJM; Debaveye, Y; Jansen, AME; Mertens, B; Schouten, J; Spriet, I; Ter Heine, R; Verweij, PE; Wauters, J, 2023
)
1.43
" Blood samples were collected on eight timepoints over one dosing interval between days 3-7 of treatment and optionally on one timepoint after discontinuation."( Population Pharmacokinetics of Total and Unbound Isavuconazole in Critically Ill Patients: Implications for Adaptive Dosing Strategies.
Brüggemann, RJM; Debaveye, Y; Jansen, AME; Mertens, B; Schouten, J; Spriet, I; Ter Heine, R; Verweij, PE; Wauters, J, 2023
)
1.16
" The proposed adaptive dosing strategy resulted in an increase to 62."( Population Pharmacokinetics of Total and Unbound Isavuconazole in Critically Ill Patients: Implications for Adaptive Dosing Strategies.
Brüggemann, RJM; Debaveye, Y; Jansen, AME; Mertens, B; Schouten, J; Spriet, I; Ter Heine, R; Verweij, PE; Wauters, J, 2023
)
1.16
" We proposed an adaptive dosing approach to enhance early treatment optimisation in this high-risk population."( Population Pharmacokinetics of Total and Unbound Isavuconazole in Critically Ill Patients: Implications for Adaptive Dosing Strategies.
Brüggemann, RJM; Debaveye, Y; Jansen, AME; Mertens, B; Schouten, J; Spriet, I; Ter Heine, R; Verweij, PE; Wauters, J, 2023
)
1.16
"Seven of 15 patients (47%) received standard isavuconazole loading dosage with 200 mg as the first dose, 3/15 (20%) received 300 mg, and 5/15 (33%) received 400 mg isavuconazole as the first dose, followed by subsequent standard dosing in all patients."( Early attainment of isavuconazole target concentration using an increased loading dose in critically ill patients with extracorporeal membrane oxygenation.
Eller, P; Grinschgl, Y; Hatzl, S; Hoenigl, M; Krause, R; Kriegl, L; Meinitzer, A; Muhr, T; Posch, F; Reisinger, A; Schilcher, G, 2023
)
1.49
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
ergosterol biosynthesis inhibitorAny compound that inhibits one or more steps in the pathway leading to the synthesis of ergosterol.
EC 1.14.13.70 (sterol 14alpha-demethylase) inhibitorAn EC 1.14.13.* (oxidoreductase acting on paired donors, incorporating 1 atom of oxygen, with NADH or NADPH as one donor) inhibitor that interferes with the action of EC 1.14.13.70 (sterol 14alpha-demethylase).
orphan drugAny drug that has been developed specifically for treatment of a rare medical condition, the condition itself being known as an orphan disease.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (6)

ClassDescription
1,3-thiazoles
nitrileA compound having the structure RC#N; thus a C-substituted derivative of hydrocyanic acid, HC#N. In systematic nomenclature, the suffix nitrile denotes the triply bound #N atom, not the carbon atom attached to it.
difluorobenzeneAny member of the class of fluorobenzenes containing a mono- or poly-substituted benzene ring carrying two fluorine atoms.
tertiary alcoholA tertiary alcohol is a compound in which a hydroxy group, -OH, is attached to a saturated carbon atom which has three other carbon atoms attached to it.
triazole antifungal drugAny triazole antifungal agent that has been used for the treatment of fungal infections in humans or animals.
conazole antifungal drugAny conazole antifungal agent that has been used for the treatment of fungal infections in animals or humans.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (9)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency1.89990.01237.983543.2770AID1645841
GVesicular stomatitis virusPotency6.00810.01238.964839.8107AID1645842
cytochrome P450 2D6Homo sapiens (human)Potency18.99910.00108.379861.1304AID1645840
Interferon betaHomo sapiens (human)Potency6.00810.00339.158239.8107AID1645842
HLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)Potency6.00810.01238.964839.8107AID1645842
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency31.97980.009610.525035.4813AID1479145; AID1479148
Inositol hexakisphosphate kinase 1Homo sapiens (human)Potency6.00810.01238.964839.8107AID1645842
cytochrome P450 2C9, partialHomo sapiens (human)Potency6.00810.01238.964839.8107AID1645842
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Broad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)IC50 (µMol)11.00000.00401.966610.0000AID1873196
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (59)

Processvia Protein(s)Taxonomy
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
positive regulation of T cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
adaptive immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class I via ER pathway, TAP-independentHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of T cell anergyHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
defense responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
detection of bacteriumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-12 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-6 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protection from natural killer cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
innate immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of dendritic cell differentiationHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class IbHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
inositol phosphate metabolic processInositol hexakisphosphate kinase 1Homo sapiens (human)
phosphatidylinositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
negative regulation of cold-induced thermogenesisInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
lipid transportBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
organic anion transportBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
urate transportBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
biotin transportBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
sphingolipid biosynthetic processBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
riboflavin transportBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
urate metabolic processBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
transmembrane transportBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
transepithelial transportBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
renal urate salt excretionBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
export across plasma membraneBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
transport across blood-brain barrierBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
cellular detoxificationBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
xenobiotic transport across blood-brain barrierBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (30)

Processvia Protein(s)Taxonomy
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
signaling receptor bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
peptide antigen bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein-folding chaperone bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
inositol-1,3,4,5,6-pentakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol heptakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
ATP bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 1-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 3-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol 5-diphosphate pentakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol diphosphate tetrakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
ATP bindingBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
organic anion transmembrane transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
ABC-type xenobiotic transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
urate transmembrane transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
biotin transmembrane transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
efflux transmembrane transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
ATP hydrolysis activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
riboflavin transmembrane transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
ATPase-coupled transmembrane transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
identical protein bindingBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
protein homodimerization activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
xenobiotic transmembrane transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
sphingolipid transporter activityBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (28)

Processvia Protein(s)Taxonomy
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
Golgi membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
endoplasmic reticulumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
Golgi apparatusHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
cell surfaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
ER to Golgi transport vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
secretory granule membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
phagocytic vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
early endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
recycling endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular exosomeHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
lumenal side of endoplasmic reticulum membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
MHC class I protein complexHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular spaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
external side of plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
fibrillar centerInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
cytosolInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleusInositol hexakisphosphate kinase 1Homo sapiens (human)
cytoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleoplasmBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
plasma membraneBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
apical plasma membraneBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
brush border membraneBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
mitochondrial membraneBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
membrane raftBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
external side of apical plasma membraneBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
plasma membraneBroad substrate specificity ATP-binding cassette transporter ABCG2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (158)

Assay IDTitleYearJournalArticle
AID1347159Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347160Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID519513Antifungal activity against Candida tropicalis isolates after 48 hrs by CLSI M27-A2 procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID567444Antifungal activity against Trichosporon asahii after 48 hrs by Etest2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID567435Antifungal activity against Trichosporon mucoides after 48 hrs by broth microdilution method2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID519491Antifungal activity against Aspergillus fumigatus isolates after 48 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519517Antifungal activity against Aspergillus flavus isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID557631Fungicidal activity against Rhizopus2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID519528Antifungal activity against Candida albicans isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID567429Antifungal activity against Dipodascus capitatus after 48 hrs by broth microdilution method2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID519516Antifungal activity against Aspergillus fumigatus isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519465Antimicrobial activity against Cryptococcus neoformans var. grubii clinical isolate by broth microdilution method2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In Vitro activity of the new azole isavuconazole (BAL4815) compared with six other antifungal agents against 162 Cryptococcus neoformans isolates from Cuba.
AID557627Fungicidal activity against Aspergillus flavus2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID559002Ratio of AUC to MIC in mouse infected with Candida albicans FA/6862 at 6.74 mg/kg, sc BID2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID567431Antifungal activity against Rhodotorula mucilaginosa after 48 hrs by broth microdilution method2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID558990Terminal half life in mouse at 1.6 to 13 mg/kg, sc2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID557608Antifungal activity against amphotericin B-resistant Aspergillus terreus by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID557614Antifungal activity against Mucor by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID519515Antifungal activity against Candida krusei isolates after 48 hrs by CLSI M27-A2 procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519527Antifungal activity against Scedosporium prolificans isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID567434Antifungal activity against Saccharomyces cerevisiae after 48 hrs by Etest2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID519468Antimicrobial activity against Cryptococcus gattii by broth microdilution method2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In Vitro activity of the new azole isavuconazole (BAL4815) compared with six other antifungal agents against 162 Cryptococcus neoformans isolates from Cuba.
AID567445Antifungal activity against Trichosporon mucoides assessed as percent susceptible isolates after 48 hrs by broth microdilution method2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID558995Ratio of AUC to MIC in mouse infected with Candida albicans FA/6862 at 5.35 mg/kg, sc administered as single dose2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID519535Antifungal activity against Fusarium sp. isolates assessed as lowest compound concentration that produced complete inhibition of microbial growth after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID557633Fungicidal activity against Cunninghamella2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID557613Antifungal activity against Rhizopus by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID519497Antifungal activity against Candida albicans isolates after 48 hrs by CLSI M27-A2 procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID567440Antifungal activity against Trichosporon jirovecii after 48 hrs by Etest2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID519498Antifungal activity against Mucor isolates assessed as lowest compound concentration that produced complete inhibition of microbial growth after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519500Antifungal activity against Rhizopus isolates assessed as lowest compound concentration that produced complete inhibition of microbial growth after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519492Antifungal activity against Aspergillus flavus isolates after 48 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID557617Antifungal activity against amphotericin B-resistant Aspergillus terreus hyphae by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID558991Antifungal activity against Candida albicans FA/6862 infected in mouse assessed as fungal load per gram of kidney at 1.6 to 13 mg/kg, sc measured after 29 hrs postinfection2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID519504Antifungal activity against Cunninghamella isolates assessed as lowest compound concentration that produced complete inhibition of microbial growth after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519531Antifungal activity against Candida tropicalis isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519467Antimicrobial activity against Cryptococcus neoformans var. grubii obtained from non-AIDS patient by broth microdilution method2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In Vitro activity of the new azole isavuconazole (BAL4815) compared with six other antifungal agents against 162 Cryptococcus neoformans isolates from Cuba.
AID525544Antimicrobial activity against Fonsecaea nubica isolates after 72 hrs by CLSI M38-A2 protocol method2010Antimicrobial agents and chemotherapy, Apr, Volume: 54, Issue:4
In vitro activities of eight antifungal drugs against 55 clinical isolates of Fonsecaea spp.
AID323595Antifungal activity against Candida glabrata bloodstream isolates by broth microdilution method2007Antimicrobial agents and chemotherapy, May, Volume: 51, Issue:5
In vitro activities of isavuconazole and other antifungal agents against Candida bloodstream isolates.
AID525542Antimicrobial activity against Fonsecaea pedrosoi isolates after 72 hrs by CLSI M38-A2 protocol method2010Antimicrobial agents and chemotherapy, Apr, Volume: 54, Issue:4
In vitro activities of eight antifungal drugs against 55 clinical isolates of Fonsecaea spp.
AID519512Antifungal activity against Candida glabrata isolates after 48 hrs by CLSI M27-A2 procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519521Antifungal activity against Mucor isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID557629Fungicidal activity against Rhizomucor2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID567437Antifungal activity against Trichosporon inkin after 48 hrs by broth microdilution method2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID323594Antifungal activity against Candida albicans bloodstream isolates by broth microdilution method2007Antimicrobial agents and chemotherapy, May, Volume: 51, Issue:5
In vitro activities of isavuconazole and other antifungal agents against Candida bloodstream isolates.
AID519493Antifungal activity against Aspergillus niger isolates after 48 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID557628Fungicidal activity against Aspergillus niger2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID519532Antifungal activity against Candida sp. isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID557637Antifungal activity against Aspergillus niger by broth microdilution method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID567426Antifungal activity against Rhodotorula mucilaginosa after 7 days by broth microdilution method2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID557626Fungicidal activity against amphotericin B-resistant Aspergillus terreus2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID567439Antifungal activity against Trichosporon jirovecii after 48 hrs by broth microdilution method2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID519510Antifungal activity against Scedosporium prolificans isolates assessed as lowest compound concentration that produced complete inhibition of microbial growth after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519464Antimicrobial activity against Cryptococcus neoformans var. grubii by broth microdilution method2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In Vitro activity of the new azole isavuconazole (BAL4815) compared with six other antifungal agents against 162 Cryptococcus neoformans isolates from Cuba.
AID519508Antifungal activity against Scedosporium apiospermum isolates assessed as lowest compound concentration that produced complete inhibition of microbial growth after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID535684Antibacterial activity against Cryptococcus gattii after 72 hrs by broth microdilution method2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Antifungal susceptibilities among different serotypes of Cryptococcus gattii and Cryptococcus neoformans.
AID567442Antifungal activity against Trichosporon domesticum after 48 hrs by Etest2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID519534Antifungal activity against Fusarium sp. isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID567443Antifungal activity against Trichosporon asahii after 48 hrs by broth microdilution method2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID519501Antifungal activity against Rhizopus isolates assessed as lowest compound concentration that produced slight growth or approximately 25% of that of growth control after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID558998Ratio of AUC to MIC in mouse infected with Candida albicans FA/6862 at 8.12 mg/kg, sc administered as single dose2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID567438Antifungal activity against Trichosporon inkin after 48 hrs by Etest2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID558987Antifungal activity against Candida albicans FA/6862 assessed as postantifungal effect at =< 1 time MIC by CLSI M27-A2 method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID323597Antifungal activity against Candida parapsilosis bloodstream isolates by broth microdilution method2007Antimicrobial agents and chemotherapy, May, Volume: 51, Issue:5
In vitro activities of isavuconazole and other antifungal agents against Candida bloodstream isolates.
AID519502Antifungal activity against Absidia isolates assessed as lowest compound concentration that produced complete inhibition of microbial growth after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID557636Antifungal activity against amphotericin B-resistant Aspergillus terreus by broth microdilution method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID567430Antifungal activity against Dipodascus capitatus after 48 hrs by Etest2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID567446Antifungal activity against Trichosporon mucoides assessed as percent susceptible/dose-dependent isolates after 48 hrs by broth microdilution method2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID557618Antifungal activity against Aspergillus flavus hyphae by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID323599Antifungal activity against Candida sp. bloodstream isolates by broth microdilution method2007Antimicrobial agents and chemotherapy, May, Volume: 51, Issue:5
In vitro activities of isavuconazole and other antifungal agents against Candida bloodstream isolates.
AID558986Antifungal activity against Candida albicans FA/6862 by CLSI M27-A2 method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID557621Antifungal activity against Absidia hyphae by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID519466Antimicrobial activity against Cryptococcus neoformans var. grubii obtained from AIDS patient by broth microdilution method2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In Vitro activity of the new azole isavuconazole (BAL4815) compared with six other antifungal agents against 162 Cryptococcus neoformans isolates from Cuba.
AID535689Antibacterial activity against Cryptococcus gattii serotype B after 72 hrs by broth microdilution method2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Antifungal susceptibilities among different serotypes of Cryptococcus gattii and Cryptococcus neoformans.
AID1817568Antifungal activity against pan-azole resistant Aspergillus fumigatus SR47013 harbouring Cyp51A Y121F mutant assessed as inhibition of fungal growth incubated for 24 hrs by broth microdilution method2021Journal of medicinal chemistry, 07-22, Volume: 64, Issue:14
Identification of Thiazoyl Guanidine Derivatives as Novel Antifungal Agents Inhibiting Ergosterol Biosynthesis for Treatment of Invasive Fungal Infections.
AID519533Antifungal activity against Candida krusei isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID557607Antifungal activity against Aspergillus fumigatus by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID535687Antibacterial activity against Cryptococcus neoformans serotype D after 72 hrs by broth microdilution method2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Antifungal susceptibilities among different serotypes of Cryptococcus gattii and Cryptococcus neoformans.
AID535686Antibacterial activity against Cryptococcus neoformans serotype A after 72 hrs by broth microdilution method2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Antifungal susceptibilities among different serotypes of Cryptococcus gattii and Cryptococcus neoformans.
AID519496Antifungal activity against Candida parapsilosis isolates after 48 hrs by CLSI M27-A2 procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519581Antifungal activity against Aspergillus terreus isolates after 48 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID557609Antifungal activity against Aspergillus flavus by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID567436Antifungal activity against Trichosporon mucoides after 48 hrs by Etest2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID567432Antifungal activity against Rhodotorula mucilaginosa after 48 hrs by Etest2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID557611Antifungal activity against Rhizomucor by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID519470Antimicrobial activity against Cryptococcus albidosimilis by broth microdilution method2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In Vitro activity of the new azole isavuconazole (BAL4815) compared with six other antifungal agents against 162 Cryptococcus neoformans isolates from Cuba.
AID567441Antifungal activity against Trichosporon domesticum after 48 hrs by broth microdilution method2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID559000Ratio of AUC to MIC in mouse infected with Candida albicans FA/6862 at 2.03 mg/kg, sc QID2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID519514Antifungal activity against Candida sp. isolates after 48 hrs by CLSI M27-A2 procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID557632Fungicidal activity against Mucor2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID519506Antifungal activity against Syncephalastrum isolates assessed as lowest compound concentration that produced complete inhibition of microbial growth after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519469Antimicrobial activity against Cryptococcus albidus by broth microdilution method2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In Vitro activity of the new azole isavuconazole (BAL4815) compared with six other antifungal agents against 162 Cryptococcus neoformans isolates from Cuba.
AID525190Antimicrobial activity against Cryptococcus neoformans by Etest method2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Evaluation of Etest method for determining isavuconazole MICs against Cryptococcus gattii and Cryptococcus neoformans.
AID519519Antifungal activity against Aspergillus terreus isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID557616Antifungal activity against Aspergillus fumigatus hyphae by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID519523Antifungal activity against Absidia isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519511Antifungal activity against Scedosporium prolificans isolates assessed as lowest compound concentration that produced slight growth or approximately 25% of that of growth control after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519509Antifungal activity against Scedosporium apiospermum isolates assessed as lowest compound concentration that produced slight growth or approximately 25% of that of growth control after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519525Antifungal activity against Syncephalastrum isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID557619Antifungal activity against Aspergillus niger hyphae by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID567333Antifungal activity against Saccharomyces cerevisiae after 5 days by broth microdilution method2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID519529Antifungal activity against Candida parapsilosis isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID559003Ratio of AUC to MIC in mouse infected with Candida albicans FA/6862 at 13.37 mg/kg, sc QID2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID557620Antifungal activity against Rhizomucor hyphae by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID535688Antibacterial activity against Cryptococcus neoformans serotype AD after 72 hrs by broth microdilution method2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Antifungal susceptibilities among different serotypes of Cryptococcus gattii and Cryptococcus neoformans.
AID567433Antifungal activity against Saccharomyces cerevisiae after 48 hrs by broth microdilution method2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID519518Antifungal activity against Aspergillus niger isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519520Antifungal activity against Aspergillus sp. isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519505Antifungal activity against Cunninghamella isolates assessed as lowest compound concentration that produced slight growth or approximately 25% of that of growth control after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID567425Antifungal activity against Rhodotorula mucilaginosa after 7 days by Etest2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID557625Fungicidal activity against Aspergillus fumigatus2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID519530Antifungal activity against Candida glabrata isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519522Antifungal activity against Rhizopus isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID557612Antifungal activity against Absidia by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID519536Antifungal activity against Fusarium sp. isolates assessed as lowest compound concentration that produced slight growth or approximately 25% of that of growth control after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519499Antifungal activity against Mucor isolates assessed as lowest compound concentration that produced slight growth or approximately 25% of that of growth control after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID1873196Inhibition of ABCG2 (unknown origin) expressed in human HEK293 cells membrane vesicles assessed inhibition of BCRP- mediated transport of 3[H]-E1S for 1 mins using [3H]-estrone sulfate as substrate by liquid scintillation counter analysis2022European journal of medicinal chemistry, Jul-05, Volume: 237Targeting breast cancer resistance protein (BCRP/ABCG2): Functional inhibitors and expression modulators.
AID323598Antifungal activity against Candida tropicalis bloodstream isolates by broth microdilution method2007Antimicrobial agents and chemotherapy, May, Volume: 51, Issue:5
In vitro activities of isavuconazole and other antifungal agents against Candida bloodstream isolates.
AID525543Antimicrobial activity against Fonsecaea monophora isolates after 72 hrs by CLSI M38-A2 protocol method2010Antimicrobial agents and chemotherapy, Apr, Volume: 54, Issue:4
In vitro activities of eight antifungal drugs against 55 clinical isolates of Fonsecaea spp.
AID557610Antifungal activity against Aspergillus niger by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID557622Antifungal activity against Rhizopus hyphae by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID567447Antifungal activity against Trichosporon sp. after 3 days by broth microdilution method2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID535685Antibacterial activity against Cryptococcus neoformans after 72 hrs by broth microdilution method2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Antifungal susceptibilities among different serotypes of Cryptococcus gattii and Cryptococcus neoformans.
AID525188Antimicrobial activity against Cryptococcus gattii by Etest method2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Evaluation of Etest method for determining isavuconazole MICs against Cryptococcus gattii and Cryptococcus neoformans.
AID323596Antifungal activity against Candida krusei bloodstream isolates by broth microdilution method2007Antimicrobial agents and chemotherapy, May, Volume: 51, Issue:5
In vitro activities of isavuconazole and other antifungal agents against Candida bloodstream isolates.
AID519495Antifungal activity against Aspergillus sp. isolates after 48 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID525187Antimicrobial activity against Cryptococcus gattii by broth microdilution method2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Evaluation of Etest method for determining isavuconazole MICs against Cryptococcus gattii and Cryptococcus neoformans.
AID567427Antifungal activity against Dipodascus capitatus after 3 days by broth microdilution method2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID558994Ratio of AUC to MIC in mouse infected with Candida albicans FA/6862 at 0.82 mg/kg, sc QID2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID557615Antifungal activity against Cunninghamella by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID535690Antibacterial activity against Cryptococcus gattii serotype C after 72 hrs by broth microdilution method2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Antifungal susceptibilities among different serotypes of Cryptococcus gattii and Cryptococcus neoformans.
AID525189Antimicrobial activity against Cryptococcus neoformans by broth microdilution method2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Evaluation of Etest method for determining isavuconazole MICs against Cryptococcus gattii and Cryptococcus neoformans.
AID557630Fungicidal activity against Absidia2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID558996Ratio of AUC to MIC in mouse infected with Candida albicans FA/6862 at 2.67 mg/kg, sc BID2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID525541Antimicrobial activity against Fonsecaea isolates after 72 hrs by CLSI M38-A2 protocol method2010Antimicrobial agents and chemotherapy, Apr, Volume: 54, Issue:4
In vitro activities of eight antifungal drugs against 55 clinical isolates of Fonsecaea spp.
AID557634Antifungal activity against Aspergillus fumigatus by broth microdilution method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID567428Antifungal activity against Dipodascus capitatus after 4 days by Etest2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID519503Antifungal activity against Absidia isolates assessed as lowest compound concentration that produced slight growth or approximately 25% of that of growth control after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID567448Antifungal activity against Trichosporon sp. after 4 days by Etest2010Antimicrobial agents and chemotherapy, Sep, Volume: 54, Issue:9
In vitro antifungal activities of isavuconazole and comparators against rare yeast pathogens.
AID559001Ratio of AUC to MIC in mouse infected with Candida albicans FA/6862 at 13.48 mg/kg, sc administered as single dose2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID557624Antifungal activity against Cunninghamella hyphae by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID558989Antifungal activity against Candida albicans FA/6862 assessed as postantifungal effect at 5 to 100 times MIC by CLSI M27-A2 method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID558992Ratio of AUC to MIC in mouse infected with Candida albicans FA/6862 at 3.27 mg/kg, sc administered as single dose2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID557623Antifungal activity against Mucor hyphae by EUCAST method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID1872531Oral bioavailability in monkey relative to control2022European journal of medicinal chemistry, Mar-05, Volume: 231Synthetic approaches and structural diversity of triazolylbutanols derived from voriconazole in the antifungal drug development.
AID519524Antifungal activity against Cunninghamella isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID519507Antifungal activity against Syncephalastrum isolates assessed as lowest compound concentration that produced slight growth or approximately 25% of that of growth control after 24 hrs by CLSI M38-A procedure based assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID558988Antifungal activity against Candida albicans FA/6862 assessed as postantifungal effect at 2 times MIC by CLSI M27-A2 method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID557635Antifungal activity against Aspergillus flavus by broth microdilution method2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID1817557Antifungal activity against Aspergillus fumigatus ATCC 204305 assessed as inhibition of fungal growth incubated for 24 hrs by broth microdilution method2021Journal of medicinal chemistry, 07-22, Volume: 64, Issue:14
Identification of Thiazoyl Guanidine Derivatives as Novel Antifungal Agents Inhibiting Ergosterol Biosynthesis for Treatment of Invasive Fungal Infections.
AID558997Ratio of AUC to MIC in mouse infected with Candida albicans FA/6862 at 1.34 mg/kg, sc QID2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID557638Plasma concentration in human2009Antimicrobial agents and chemotherapy, Apr, Volume: 53, Issue:4
In vitro activity of Isavuconazole against Aspergillus species and zygomycetes according to the methodology of the European Committee on Antimicrobial Susceptibility Testing.
AID558993Ratio of AUC to MIC in mouse infected with Candida albicans FA/6862 at 1.63 mg/kg, sc BID2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
AID519526Antifungal activity against Scedosporium apiospermum isolates by Etest2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
In vitro antifungal activities of isavuconazole (BAL4815), voriconazole, and fluconazole against 1,007 isolates of zygomycete, Candida, Aspergillus, Fusarium, and Scedosporium species.
AID558999Ratio of AUC to MIC in mouse infected with Candida albicans FA/6862 at 4.06 mg/kg, sc BID2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (366)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's20 (5.46)29.6817
2010's202 (55.19)24.3611
2020's144 (39.34)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 62.66

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index62.66 (24.57)
Research Supply Index6.03 (2.92)
Research Growth Index5.64 (4.65)
Search Engine Demand Index104.85 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (62.66)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials37 (9.84%)5.53%
Reviews66 (17.55%)6.00%
Case Studies60 (15.96%)4.05%
Observational3 (0.80%)0.25%
Other210 (55.85%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (45)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Single Center, Open-label Trial of Isavuconazole Prophylaxis Against Invasive Fungal Infection in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT) [NCT03149055]Phase 299 participants (Actual)Interventional2017-05-04Completed
A Phase 1, Open-Label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Digoxin in Healthy Adult Subjects [NCT01582412]Phase 124 participants (Actual)Interventional2012-03-31Completed
A SINGLE ARM, PROSPECTIVE, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF ISAVUCONAZOLE FOR PRIMARY TREATMENT OF CHINESE PATIENTS WITH INVASIVE FUNGAL DISEASE (IFD) CAUSED BY ASPERGILLUS SPECIES OR OTHER FILAMENTOUS FUNGI [NCT05630976]Phase 456 participants (Anticipated)Interventional2023-02-07Recruiting
A Phase 1, Open-label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients [NCT03241550]Phase 149 participants (Actual)Interventional2017-10-02Completed
A Phase 1 Open-Label Mass Balance Study to Evaluate the Pharmacokinetics of BAL8728 After A Single Intravenous Dose of 14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects [NCT02059590]Phase 16 participants (Actual)Interventional2013-04-30Completed
A Phase 1 Randomized Open Label, Parallel Group Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole [NCT02128893]Phase 124 participants (Actual)Interventional2014-01-31Completed
Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, Rituximab (TEDDI-R) in Primary CNS Lymphoma [NCT02203526]Phase 193 participants (Anticipated)Interventional2014-08-14Recruiting
Isavuconazole for the Prevention of SARS-CoV-2-associated Invasive Aspergillosis in Critically-Ill Patients [NCT04707703]Phase 38 participants (Actual)Interventional2021-03-16Terminated(stopped due to Participant enrollment challenges)
A Phase 1 Open Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Repaglinide and Caffeine [NCT02128321]Phase 124 participants (Actual)Interventional2014-01-31Completed
A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections [NCT00413218]Phase 3450 participants (Actual)Interventional2007-03-08Completed
A Phase 1, Open-Label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Methadone in Healthy Adult Subjects [NCT01582425]Phase 124 participants (Actual)Interventional2012-04-30Completed
Patterns of Real-World Isavuconazole Use, Effectiveness, Safety, and Healthcare Resource Utilization-a Retrospective Chart Review Study of Patients With Mucormycosis or Invasive Aspergillosis (PRISMA) [NCT04550936]600 participants (Anticipated)Observational2021-03-10Recruiting
A Phase 1, Randomized, Double Blind, Placebo and Active Controlled, Parallel Study to Evaluate the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization in Healthy Adult Subjects [NCT01565720]Phase 1161 participants (Actual)Interventional2012-03-31Completed
A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi. [NCT00412893]Phase 3527 participants (Actual)Interventional2007-03-07Completed
A Phase 1, Open-Label, Drug Interaction Study of the Pharmacokinetics of Isavuconazole and Midazolam After Separate and Concomitant Administration to Healthy Adult Subjects [NCT01406171]Phase 124 participants (Actual)Interventional2011-05-31Completed
A Phase 1 Crossover Study to Assess the Bioequivalence of Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Subjects [NCT04096157]Phase 117 participants (Actual)Interventional2019-09-24Completed
A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin [NCT01884558]Phase 124 participants (Actual)Interventional2013-02-28Completed
A Phase 1, Open- Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Methotrexate [NCT01884636]Phase 124 participants (Actual)Interventional2013-02-28Completed
A Phase 2, Open-Label, Non-Comparative, Multicenter Study to Evaluate the Safety and Tolerability, Efficacy and Pharmacokinetics of Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Subject [NCT03816176]Phase 231 participants (Actual)Interventional2019-08-22Completed
Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Cyclosporine: A Phase 1, Open-Label, Sequential Study in Healthy Adult Subjects [NCT01494597]Phase 124 participants (Actual)Interventional2011-11-30Completed
A Study of Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS) [NCT03964090]Phase 265 participants (Anticipated)Interventional2019-06-27Recruiting
Translational PKPD Modeling of Anti-infective Drugs in Children Treated in Pediatric Units on the Example of Selected Antibiotics and Antifungals. [NCT05426499]150 participants (Anticipated)Observational2021-10-01Active, not recruiting
A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Atorvastatin [NCT01635946]Phase 124 participants (Actual)Interventional2012-08-31Completed
Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi [NCT00634049]Phase 3149 participants (Actual)Interventional2008-04-22Completed
LCCC1841: A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas [NCT04548648]Phase 216 participants (Anticipated)Interventional2020-10-15Recruiting
Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Tacrolimus: A Phase 1, Open Label, Sequential Study in Healthy Adult Subjects [NCT01535547]Phase 124 participants (Actual)Interventional2011-12-31Completed
A Phase 1 Open Label, 2 Part, Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole [NCT01555866]Phase 149 participants (Actual)Interventional2012-03-31Completed
A Phase I, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Isavuconazole in Healthy Chinese Volunteers [NCT01555918]Phase 136 participants (Actual)Interventional2012-08-31Completed
An Open-Label, Fixed Sequence Study in Healthy Subjects to Assess the Pharmacokinetics of Acalabrutinib and Its Active Metabolite, ACP-5862, When Administered Alone and in Combination With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole [NCT05140096]Phase 130 participants (Actual)Interventional2020-01-03Completed
A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Bupropion [NCT01635972]Phase 124 participants (Actual)Interventional2012-06-30Completed
A Phase 1, Open-Label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Dextromethorphan in Healthy Adult Subjects [NCT01651325]Phase 124 participants (Actual)Interventional2012-05-31Completed
A Phase 1, Open-Label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Warfarin in Healthy Male Subjects [NCT01657825]Phase 120 participants (Actual)Interventional2012-06-30Completed
A Phase 1, Randomized, Open-Label, Two-Arm, Parallel Group Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects [NCT01657838]Phase 124 participants (Actual)Interventional2012-05-31Completed
A Phase 1, Open Label, Parallel Group, Single Dose Study to Evaluate the Pharmacokinetics of Isavuconazole in Healthy Non-Elderly and Elderly Male and Female Subjects [NCT01657890]Phase 128 participants (Actual)Interventional2012-06-30Completed
A Phase 1, Open-Label, Parallel Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Multiple Doses of Lopinavir/Ritonavir and the Effects of Lopinavir/Ritonavir on the Pharmacokinetics of Multiple Doses of Isavuconaz [NCT01660477]Phase 168 participants (Actual)Interventional2012-06-30Completed
A Phase 1, Open-Label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Mycophenolate Mofetil in Healthy Adult Subjects [NCT01711489]Phase 124 participants (Actual)Interventional2012-03-31Completed
A Phase 1, Open-label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Adult Subjects [NCT01711827]Phase 121 participants (Actual)Interventional2012-02-29Completed
Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Sirolimus: A Phase 1, Open-Label, Sequential Study in Healthy Adult Subjects [NCT01809860]Phase 122 participants (Actual)Interventional2011-11-30Completed
A Phase 1 Open-Label Mass Balance Study to Evaluate the Pharmacokinetics of Isavuconazole After a Single Oral Dose of 14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects [NCT01813461]Phase 18 participants (Actual)Interventional2012-10-31Completed
A Phase II Study of Isavuconazole Prophylaxis in Adult Patients With AML/MDS and Neutropenia [NCT03019939]Phase 265 participants (Actual)Interventional2017-03-28Completed
Open Label, Multi-center, Sequential Group Clinical Study to Determine the Safety and Efficacy of Escalating Dosing Regimens of Intravenous BAL8557 in the Prophylaxis of Patients Undergoing Chemotherapy for Acute Myeloid Leukemia [NCT00413439]Phase 2/Phase 318 participants (Actual)Interventional2006-05-31Completed
Azole-echinocandin Combination Therapy for Invasive Aspergillosis A Randomized Pragmatic Superiority Trial [NCT04876716]Phase 3650 participants (Anticipated)Interventional2021-05-11Recruiting
A Phase 1, Open Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone [NCT01597986]Phase 124 participants (Actual)Interventional2012-04-30Completed
Observational Disease Registry of Patients Treated With Systemic Mold-Active Triazoles [NCT03066011]2,015 participants (Actual)Observational2017-03-16Completed
A Phase 2 Study of VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis in Adults With Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, or Allogeneic Hematopoietic Cell Transplant Recipients [NCT03327727]Phase 24 participants (Actual)Interventional2018-02-20Terminated(stopped due to Business decision)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00412893 (10) [back to overview]Percentage of Participants With a Clinical Response Assessed by the DRC
NCT00412893 (10) [back to overview]All-cause Mortality Through Day 42
NCT00412893 (10) [back to overview]All-cause Mortality Through Day 84
NCT00412893 (10) [back to overview]Number of Participants With Adverse Events, Reported by System Organ Class
NCT00412893 (10) [back to overview]Percentage of Participants With a Clinical Response Assessed by the Investigator
NCT00412893 (10) [back to overview]Percentage of Participants With a Mycological Response Assessed by the DRC
NCT00412893 (10) [back to overview]Percentage of Participants With a Mycological Response Assessed by the Investigator
NCT00412893 (10) [back to overview]Percentage of Participants With a Radiological Response Assessed by the DRC
NCT00412893 (10) [back to overview]Percentage of Participants With a Radiological Response Assessed by the Investigator
NCT00412893 (10) [back to overview]Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC)
NCT00413218 (9) [back to overview]Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use
NCT00413218 (9) [back to overview]Time to First Confirmed Negative Culture
NCT00413218 (9) [back to overview]All-Cause Mortality (ACM) at Day 14 and Day 56
NCT00413218 (9) [back to overview]Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator
NCT00413218 (9) [back to overview]Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)
NCT00413218 (9) [back to overview]Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)
NCT00413218 (9) [back to overview]Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)
NCT00413218 (9) [back to overview]Percentage of Participants With Overall Response of Success at EOT and Follow Up Visit 2 (FU2) as Determined by the DRC Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use at EOT and FU2
NCT00413218 (9) [back to overview]Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator
NCT00634049 (9) [back to overview]Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
NCT00634049 (9) [back to overview]Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).
NCT00634049 (9) [back to overview]Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
NCT00634049 (9) [back to overview]Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
NCT00634049 (9) [back to overview]Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
NCT00634049 (9) [back to overview]All-cause Mortality Through Day 42 and Day 84
NCT00634049 (9) [back to overview]Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
NCT00634049 (9) [back to overview]Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
NCT00634049 (9) [back to overview]Safety - Overall Number of TEAEs
NCT03019939 (11) [back to overview]Number of Participants With Other Invasive Fungal Infections (IFIs)
NCT03019939 (11) [back to overview]Invasive Fungal Infections (IFIs)-Free Survival
NCT03019939 (11) [back to overview]Number of Participants Who Failed Treatment
NCT03019939 (11) [back to overview]Number of Participants With Death Related to Invasive Fungal Infections (IFIs)
NCT03019939 (11) [back to overview]Number of Participants With Invasive Aspergillosis
NCT03019939 (11) [back to overview]Number of Participants With Proven or Probable Invasive Fungal Infections (IFIs)
NCT03019939 (11) [back to overview]Number of Participants With Treatment Success
NCT03019939 (11) [back to overview]Overall Survival (OS)
NCT03019939 (11) [back to overview]Time to Death From Any Cause
NCT03019939 (11) [back to overview]Time to Diagnosis of Proven or Probable Invasive Fungal Infections (IFIs)
NCT03019939 (11) [back to overview]Time to Initiation of Empiric Anti-fungal Therapy
NCT03816176 (11) [back to overview]Pharmacokinetics of Isavuconazonium Sulphate in Plasma: Trough Concentration (Ctrough)
NCT03816176 (11) [back to overview]Percentage of Participants With Mycological Response: AC Assessment
NCT03816176 (11) [back to overview]Percentage of Participants With Overall Response: Adjudication Committee (AC) Assessment
NCT03816176 (11) [back to overview]Percentage of Participants With Clinical Response: Investigator Assessment
NCT03816176 (11) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs)
NCT03816176 (11) [back to overview]Percentage of Participants With Clinical Response: AC Assessment
NCT03816176 (11) [back to overview]Percentage of Participants With All - Cause Mortality
NCT03816176 (11) [back to overview]Percentage of Participants With All - Cause Mortality Through Day 42
NCT03816176 (11) [back to overview]Percentage of Participants With Radiological Response: AC Assessment
NCT03816176 (11) [back to overview]Percentage of Participants With Radiological Response: Investigator Assessment
NCT03816176 (11) [back to overview]Percentage of Participats With Mycological Response: Investigator Assessment

Percentage of Participants With a Clinical Response Assessed by the DRC

"Blinded assessments of clinical symptoms and physical findings of invasive fungal disease were performed by the independent DRC.~Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening. Participants with no attributable signs and symptoms present at Baseline and no symptoms attributable to invasive fungal disease (IFD) developed post-baseline were classified as Not Applicable. End of treatment is the last day of study drug administration." (NCT00412893)
Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

,
Interventionpercentage of participants (Number)
Day 42 (n=139, 120)Day 84 (n=141, 124)End of Treatment (n=137, 121)
Isavuconazole64.046.162.0
Voriconazole57.544.460.3

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All-cause Mortality Through Day 42

All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 42 from any cause. Participants with unknown survival status through Day 42 were included as deaths in the calculation. (NCT00412893)
Timeframe: Through Day 42

Interventionpercentage of participants (Number)
Isavuconazole18.6
Voriconazole20.2

[back to top]

All-cause Mortality Through Day 84

All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 84 from any cause. Participants with unknown survival status through Day 84 were included as deaths in the calculation. (NCT00412893)
Timeframe: Through Day 84

Interventionpercentage of participants (Number)
Isavuconazole29.1
Voriconazole31.0

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Number of Participants With Adverse Events, Reported by System Organ Class

(NCT00412893)
Timeframe: From the first study drug administration until 28 days after the last dose of study drug. The median duration of study drug administration was 45 days.

,
Interventionparticipants (Number)
Patients with ≥ 1 TEAEGastrointestinal DisordersInfections and InfestationsGeneral Disorders / Administration Site ConditionsRespiratory, Thoracic and Mediastinal DisordersMetabolism and Nutrition DisordersNervous System DisordersSkin and Subcutaneous Tissue DisordersInvestigationsBlood and Lymphatic System DisordersPsychiatric DisordersMusculoskeletal and Connective Tissue DisordersVascular DisordersRenal and Urinary DisordersCardiac DisordersEye DisordersInjury, Poisoning and Procedural ComplicationsHepatobiliary DisordersImmune System DisordersNeoplasms benign, malignant and unspecifiedEar and Labyrinth DisordersReproductive System and Breast DisordersEndocrine DisordersCongenital, Familial and Genetic DisordersSocial Circumstances
Isavuconazole2471741521481431089586857770696755433933232019148530
Voriconazole255180158144147121891109682867777585769394225311313321

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Percentage of Participants With a Clinical Response Assessed by the Investigator

"Assessment of clinical symptoms and physical findings of invasive fungal disease were performed by the investigator.~Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening, or if results were unavailable or the participant was unevaluable. Participants with no attributable signs and symptoms present at Baseline were classified as Not Applicable. End of treatment is the last day of study drug administration." (NCT00412893)
Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

,
Interventionpercentage of participants (Number)
Day 42 (n=137, 120)Day 84 (n=140, 122)End of Treatment (n=137, 121)
Isavuconazole64.241.462.0
Voriconazole61.744.364.5

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Percentage of Participants With a Mycological Response Assessed by the DRC

"Blinded mycological assessments of the participant's invasive fungal disease status were performed by the independent DRC using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site.~Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline were classified as Not Applicable.~End of treatment is the last day of study drug administration." (NCT00412893)
Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

,
Interventionpercentage of participants (Number)
Day 42Day 84End of Treatment
Isavuconazole39.928.037.8
Voriconazole39.536.441.1

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Percentage of Participants With a Mycological Response Assessed by the Investigator

"Mycological assessments of the participant's invasive fungal disease status were performed by the investigator using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site.~Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline, or no mycological follow-up results available or indeterminate results were classified as Not Applicable.~End of treatment is the last day of study drug administration." (NCT00412893)
Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

,
Interventionpercentage of participants (Number)
Day 42 (n=109, 100)Day 84 (n=126, 117)End of Treatment (n=107, 100)
Isavuconazole52.335.750.5
Voriconazole50.037.655.0

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Percentage of Participants With a Radiological Response Assessed by the DRC

"Independent reviews of radiology assessments were completed by radiology experts which were provided to the independent, blinded DRC. Blinded radiological assessments were performed by the DRC.~Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Participants without any radiology at Baseline were considered Not Applicable. End of Treatment is the last day of study drug administration." (NCT00412893)
Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

,
Interventionpercentage of participants (Number)
Day 42 (n=141, 128)Day 84 (n=141, 128)End of Treatment (n=141, 127)
Isavuconazole28.422.029.1
Voriconazole34.429.733.1

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Percentage of Participants With a Radiological Response Assessed by the Investigator

"Radiological assessments were performed by the investigator. Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Failure is defined as a < 25% improvement at any time or results not available. Participants with no signs on radiological images at Baseline were considered Not Applicable. End of Treatment is the last day of study drug administration." (NCT00412893)
Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

,
Interventionpercentage of participants (Number)
Day 42 (n=142, 128)Day 84 (n=141, 128)End of Treatment (n=141, 128)
Isavuconazole45.138.343.3
Voriconazole51.641.447.7

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Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC)

"The DRC was an independent, blinded committee consisting of experts in the field of infectious disease who assessed patients' outcomes. The overall response was based on the DRC-assessed clinical, mycological and radiological responses.~Success was defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings, the eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline and a > 50% improvement in radiological response from Baseline (or improvement of at least 25% from Baseline for the Day 42 analysis or End of Treatment if it occurred prior to Day 42).~End of treatment (EOT) is the last day of study drug administration. For the Day 42 and Day 84 analyses, any visits that the DRC assessed as Not Done were considered a failure for that visit. A death before Day 42 was also considered a failure, even if the DRC assessed the participant to be a success prior to death." (NCT00412893)
Timeframe: Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.

,
Interventionpercentage of participants (Number)
Day 42Day 84End of Treatment
Isavuconazole35.725.235.0
Voriconazole35.732.636.4

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Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use

A Data Review Committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication) without the use of alternative systemic antifungal therapy (AFT) within 48 hours after the last dose of IV study medication. (NCT00413218)
Timeframe: End of Intravenous Treatment (EOIV) (Days 11-56)

InterventionPercentage of Participants (Number)
Isavuconazole (ISA)60.3
Caspofungin (CAS)/Voriconazole71.1

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Time to First Confirmed Negative Culture

The first confirmed negative blood culture was defined as the first negative blood culture on or after first dose followed by a second negative blood culture at least 24 hours apart without any positive blood cultures in between. A participant without a confirmed negative blood culture was censored on the participant's last visit day. This endpoint was analyzed for mITT participants with candidemia only using the Kaplan-Meier method. Only participants with at least one positive blood culture on or prior to first dose and the culture not resolved prior to first dose were included in this analysis (NCT00413218)
Timeframe: Day 1 up to FU1 (2 weeks after EOT (Day 56))

InterventionDays (Median)
Isavuconazole (ISA)4.0
Caspofungin (CAS)/Voriconazole3.0

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All-Cause Mortality (ACM) at Day 14 and Day 56

All-cause mortality is represented as the percentage of participants who died on or before the analysis day. Participants who were lost to follow-up (i.e., unknown survival status) before the analysis day were counted as death. All-cause mortality was examined on Day 14 and Day 56. (NCT00413218)
Timeframe: Day 14 and Day 56

,
InterventionPercentage of Participants (Number)
Day 14 All-cause MortalityDay 56 All-cause Mortality
Caspofungin (CAS)/Voriconazole12.429.9
Isavuconazole (ISA)14.630.7

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Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator

Investigators defined clinical response as success if participants exhibited complete or partial clinical response after evaluation of clinical signs and symptoms. (NCT00413218)
Timeframe: Day 7 and EOT (Day 56)

,
InterventionPercentage of Participants (Number)
Day 7EOT
Caspofungin (CAS)/Voriconazole64.778.6
Isavuconazole (ISA)54.370.9

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Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)

A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial). (NCT00413218)
Timeframe: EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)

,
InterventionPercentage of Participants (Number)
Success- End of Intravenous Treatment (EOIV)Success- End of Treatment (EOT)Success- Follow-up Visit 1 (FU1)Success- Follow-up Visit 2 (FU2)
Caspofungin (CAS)/Voriconazole84.184.667.758.2
Isavuconazole (ISA)76.476.467.852.8

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Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)

A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic AFT within 48 hours after the last dose of IV study medication. (NCT00413218)
Timeframe: End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment)

InterventionPercentage of Participants (Number)
Isavuconazole (ISA)54.8
Caspofungin (CAS)/Voriconazole57.2

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Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)

A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as mycological response (Eradication or Presumed Eradication). (NCT00413218)
Timeframe: EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)

,
InterventionPercentage of Participants (Number)
Success-EOIVSuccess-EOTSuccess-FU1Success-FU2
Caspofungin (CAS)/Voriconazole85.687.665.756.7
Isavuconazole (ISA)70.971.966.851.8

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Percentage of Participants With Overall Response of Success at EOT and Follow Up Visit 2 (FU2) as Determined by the DRC Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use at EOT and FU2

A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic antifungal therapy AFT within 48 hours after the last dose of IV study medication (for EOT analysis) or for continued treatment of the primary infection, or for recurrent or emergent infection by FU2, with no recurrent or emergent infection by FU2 (for FU2 analysis). (NCT00413218)
Timeframe: EOT (Day 56) and FU2 (6 weeks after end of treatment)

,
InterventionPercentage of Participants (Number)
EOT (Day 56)FU2 (6 weeks after end of treatment)
Caspofungin (CAS)/Voriconazole72.148.3
Isavuconazole (ISA)61.343.2

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Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator

Success was defined as mycological response (eradication or presumed eradication). (NCT00413218)
Timeframe: Day 7 and EOT (Day 56)

,
InterventionPercentage of Participants (Number)
Day 7EOT
Caspofungin (CAS)/Voriconazole72.181.1
Isavuconazole (ISA)61.372.9

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Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT

"The DRC evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings and Partial resolution of attributable clinical symptoms and physical findings].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days." (NCT00634049)
Timeframe: Day 42, 84 and End of Treatment (EOT [Day 180])

,,,,,,,,,
Interventionpercentage of participants (Number)
Day 42- Success RateDay 84 - Success RateEnd of Treatment (EOT) - Success Rate
mITT - Aspergillus [Not Renally Impaired]75.025.066.7
mITT - Aspergillus [Renally Impaired]55.045.055.0
mITT - Mucorales (Intolerant)50.050.050.0
mITT - Mucorales (Primary Therapy)50.040.055.6
mITT - Mucorales (Refractory)33.322.222.2
mITT- Other Dimorphic Fungi79.382.882.1
mITT- Other Mould Species Only71.442.985.7
mITT- Other Non-Candida Yeast70.070.070.0
mITT-Other Filamentous Fungi68.862.581.3
mITT-Other Mixed Infection42.935.738.5

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Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).

"The DRC assessed overall response based on individual clinical, mycological and radiological response assessments. Overall response outcomes were described as Success (complete or partial). Complete success was defined as a resolution of all clinical symptoms and physical findings associated with IFD. Partial success was defined as a resolution of at least some clinical symptoms and physical findings associated with IFD~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days." (NCT00634049)
Timeframe: Day 42, 84 and End of Treatment (EOT [Day 180])

,,,,,,,,,
Interventionpercentage of participants (Number)
Day 42- Success RateDay 84 - Success RateEnd of Treatment (EOT) - Success Rate
mITT - Aspergillus [Not Renally Impaired]50.025.066.7
mITT - Aspergillus [Renally Impaired]25.030.030.0
mITT - Mucorales (Intolerant)020.020.0
mITT - Mucorales (Primary Therapy)14.39.531.6
mITT - Mucorales (Refractory)9.136.436.4
mITT- Other Dimorphic Fungi41.444.864.3
mITT- Other Filamentous Fungi47.141.264.7
mITT- Other Mould Species Only28.628.628.6
mITT- Other Non-Candida Yeast36.436.472.7
mITT-Other Mixed Infection13.313.314.3

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Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT

"The Investigator evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication,Presumed eradication].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days." (NCT00634049)
Timeframe: Day 42, Day 84 and End of Treatment (EOT [Day 180])

,,,,,,,,,
Interventionpercentage of participants (Number)
Day 42Day 84End of Treatment (EOT)
mITT - Aspergillus [Not Renally Impaired]66.750.066.7
mITT - Aspergillus [Renally Impaired]46.744.450.0
mITT - Mucorales (Intolerant)25.020.066.7
mITT - Mucorales (Primary Therapy)50.021.442.9
mITT - Mucorales (Refractory)28.625.028.6
mITT- Other Dimorphic Fungi70.680.076.9
mITT- Other Filamentous Fungi69.264.378.6
mITT- Other Mould Species Only83.342.966.7
mITT- Other Non-Candida Yeast50.025.050.0
mITT-Other Mixed Infection18.233.325.0

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Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT

"The DRC evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication and Presumed eradication].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days." (NCT00634049)
Timeframe: Day 42, 84 and End of Treatment (EOT [Day 180])

,,,,,,,,,
Interventionpercentage of participants (Number)
Day 42- Success RateDay 84 - Success RateEnd of Treatment (EOT) - Success Rate
mITT - Aspergillus [Not Renally Impaired]50.025.066.7
mITT - Aspergillus [Renally Impaired]30.035.035.0
mITT - Mucorales (Intolerant)040.040.0
mITT - Mucorales (Primary Therapy)4.89.531.6
mITT - Mucorales (Refractory)027.336.4
mITT- Other Dimorphic Fungi27.627.653.6
mITT- Other Mould Species Only28.628.628.6
mITT- Other Non-Candida Yeast45.545.581.8
mITT-Other Filamentous Fungi29.435.370.6
mITT-Other Mixed Infection13.313.314.3

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Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT

"The Investigator evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings] and [Resolution of some attributable clinical symptoms and physical findings].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days." (NCT00634049)
Timeframe: Day 42, Day 84 and End of Treatment (EOT [Day 180])

,,,,,,,,,
Interventionpercentage of participants (Number)
Day 42Day 84End of Treatment (EOT)
mITT - Aspergillus [Not Renally Impaired]75.055.075.0
mITT - Aspergillus [Renally Impaired]60.055.060.0
mITT - Mucorales (Intolerant)25.020.066.7
mITT - Mucorales (Primary Therapy)50.021.442.9
mITT - Mucorales (Refractory)28.625.028.6
mITT- Other Dimorphic Fungi75.982.279.3
mITT- Other Filamentous Fungi81.362.581.3
mITT- Other Mould Species Only85.742.971.4
mITT- Other Non-Candida Yeast70.070.070.0
mITT-Other Mixed Infection50.035.742.9

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All-cause Mortality Through Day 42 and Day 84

"All-cause Mortality was assessed through Day 42 and Day 84 and summarized for ITT population~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days." (NCT00634049)
Timeframe: Baseline to End of Treatment (EOT [Day 180])

,
Interventionpercentage of participants (Number)
All-cause Mortality Through Day 42All-cause Mortality Through Day 84
Not Renally Impaired16.120.7
Renally Impaired22.030.5

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Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT

"The DRC evaluated radiological response to treatment at at day 42, day 84 and EOT. Radiological response outcomes were described as Success [Improvement of at least 25% from baseline for invasive aspergillosis and other filamentous mold infections], [Improvement of at least 50% from baseline for invasive aspergillosis and other filamentous mold infections]; and [Improvement of at least 25% from baseline if EOT occurs prior to day 42 and at least 50% improvement from baseline if EOT occurs after day 42 for invasive aspergillosis and other filamentous mold infections].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days." (NCT00634049)
Timeframe: Day 42, 84 and End of Treatment (EOT [Day 180])

,,,,,,,,,
Interventionpercentage of participants (Number)
Day 42- Success RateDay 84 - Success RateEnd of Treatment (EOT) - Success Rate
mITT - Aspergillus [Not Renally Impaired]25.025.066.7
mITT - Aspergillus [Renally Impaired]30.020.015.0
mITT - Mucorales (Intolerant)020.020.0
mITT - Mucorales (Primary Therapy)04.816.7
mITT - Mucorales (Refractory)10.020.020.0
mITT- Other Dimorphic Fungi21.428.633.3
mITT- Other Mould Species Only16.700
mITT- Other Non-Candida Yeast010.010.0
mITT-Other Filamentous Fungi25.06.350.0
mITT-Other Mixed Infection7.114.37.7

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Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT

"The Investigator evaluated radiological response to treatment at day 42, day 84 and EOT. Radiological response outcomes were described as Success [≥ 90% improvement,≥ 50% to < 90% improvement and ≥ 25% to < 50% improvement (for day 42 and EOT, if EOT occurs prior to day 42)].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days." (NCT00634049)
Timeframe: Day 42, Day 84 and End of Treatment (EOT [Day 180])

,,,,,,,,,
Interventionpercentage of participants (Number)
Day 42Day 84End of Treatment (EOT)
mITT - Aspergillus [Not Renally Impaired]75.050.050.0
mITT - Aspergillus [Renally Impaired]35.040.035.0
mITT - Mucorales (Intolerant)40.040.020.0
mITT - Mucorales (Primary Therapy)40.025.030.0
mITT - Mucorales (Refractory)011.122.2
mITT- Other Dimorphic Fungi32.137.055.6
mITT- Other Filamentous Fungi46.740.033.3
mITT- Other Mould Species Only20.020.040.0
mITT- Other Non-Candida Yeast9.1010.0
mITT-Other Mixed Infection28.67.114.3

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Safety - Overall Number of TEAEs

A Treatment Emergent Adverse Events (TEAE) is any adverse event that starts after the first administration of study drug until 28 days after the last dose of study drug. (NCT00634049)
Timeframe: From the first study drug administration until 28 days after the last dose of study drug

Interventionparticipants (Number)
TEAEsStudy Drug-Related TEAEsSerious TEAEsStudy Drug-Related Serious TEAEsTEAEs Leading to Permanent Discontinuation of StudStudy Drug TEAEs Leading to Perm DiscontinuationTEAEs Leading to DeathStudy Drug-Related TEAEs Leading to DeathDeathsDeaths Through 28 Days after Last Dose Study Drug
Isavuconazole1396089131974414742

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Number of Participants With Other Invasive Fungal Infections (IFIs)

Participants with other IFIs will be measured. (NCT03019939)
Timeframe: Up to 100 days from prophylaxis initiation

InterventionParticipants (Count of Participants)
Prevention (Isavuconazole)2

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Invasive Fungal Infections (IFIs)-Free Survival

Time measured in days from start of treatment to IFI or off study date (NCT03019939)
Timeframe: Up to 3 years

InterventionDays (Median)
Prevention (Isavuconazole)86

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Number of Participants Who Failed Treatment

Will evaluate versus success. Success is defined as Participants with proven or probable IFI, receipt of any other systemic antifungal agent for +/- 4 days for suspected IFI, occurrence of an adverse events possibly or probably related to the study drug resulting in discontinuation of treatment, or withdrawal from the study with no additional follow-up). (NCT03019939)
Timeframe: Up to 3 years

InterventionParticipants (Count of Participants)
Prevention (Isavuconazole)19

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Number of Participants With Invasive Aspergillosis

Participants with invasive aspergillosissured. (NCT03019939)
Timeframe: Up to 100 days from prophylaxis initiation

InterventionParticipants (Count of Participants)
Prevention (Isavuconazole)2

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Number of Participants With Proven or Probable Invasive Fungal Infections (IFIs)

Participants with proven or possible invasive fungal infections. (NCT03019939)
Timeframe: Up to 100 days from prophylaxis initiation

InterventionParticipants (Count of Participants)
Prevention (Isavuconazole)4

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Number of Participants With Treatment Success

Will evaluate versus (vs.) failure (defined as Participants with proven or probable IFI, receipt of any other systemic antifungal agent for +/- 4 days for suspected IFI, occurrence of an adverse events possibly or probably related to the study drug resulting in discontinuation of treatment, or withdrawal from the study with no additional follow-up). (NCT03019939)
Timeframe: Up to 3 years

InterventionParticipants (Count of Participants)
Prevention (Isavuconazole)46

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Overall Survival (OS)

Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT03019939)
Timeframe: Up to 3 years

InterventionMonths (Median)
Prevention (Isavuconazole)19.9

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Time to Death From Any Cause

Time to death from any cause will be measured. (NCT03019939)
Timeframe: Up to 3 years

InterventionMonths (Median)
Prevention (Isavuconazole)4

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Time to Diagnosis of Proven or Probable Invasive Fungal Infections (IFIs)

Time measured in days from start of treatment to invasive fungal infections (NCT03019939)
Timeframe: Up to 3 years

InterventionDays (Median)
Prevention (Isavuconazole)24

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Time to Initiation of Empiric Anti-fungal Therapy

Time days from start of empiric anti-fungal therapy. (NCT03019939)
Timeframe: Up to 3 years

InterventionDays (Median)
Prevention (Isavuconazole)22

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Pharmacokinetics of Isavuconazonium Sulphate in Plasma: Trough Concentration (Ctrough)

Ctrough was defined as the predose concentration at the end of dosing interval. (NCT03816176)
Timeframe: Predose on days 7, and 14

InterventionNanograms/milliter (ng/mL) (Mean)
Age group 1 to <6 Day 7Age group 1 to <6 Day 14Age group 6 to <12 Day 7Age group 6 to <12 Day 14Age group 12 to <18 Day 7Age group 12 to <18 Day 14
Isavuconazonium Sulfate2965.02286.73732.73623.33862.24380.0

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Percentage of Participants With Mycological Response: AC Assessment

"AC assessed mycological response was defined as follows:~Success: Eradicated (no growth of the original [at baseline] causative organism on culture or identified by histology/cytology on post baseline [after day 7] cultures and/or histology/cytology); Presumed Eradicated (missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding)~Failure: Persistence (persistence of the original causative organism cultured or identified by histological /cytology at baseline); Presumed Persistence (missing post baseline documentation of the persistence of the original causative organism at baseline PLUS no resolution or worsening of any clinical symptoms/physical findings)~Not Evaluable - no mycological evidence~No assessment: Those participants that do not fall under any of the above criteria" (NCT03816176)
Timeframe: Baseline up to days 42, 84 and EOT (180 days)

InterventionPercentage of participants (Number)
Day 42 SuccessDay 42 FailureDay 42 Not EvaluableDay 42 No AssessmentDay 84 SuccessDay 84 FailureDay 84 Not EvaluableDay 84 No AssessmentEOT SuccessEOT FailureEOT Not EvaluableEOT No Assessment
Isavuconazonium Sulfate19.353.2335.4841.9419.35016.1364.5235.4812.9051.610

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Percentage of Participants With Overall Response: Adjudication Committee (AC) Assessment

"Overall response was based on a composite of clinical, mycological, and radiological responses with success criteria assessed. Success criteria as assessed by AC in:~Clinical response:~Complete: Resolution of all attributable clinical symptoms and physical findings~Partial: Resolution of at Least some of the clinical symptoms and physical findings associated with IFD~Mycological response:~Eradication: No growth of the original (at baseline) causative organism on culture or identified by histology/cytology on post baseline (after day 7) cultures and/or histology/cytology~Presumed eradication: Missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding~Radiological response:~Complete: ≥ 90% improvement~Partial: At least < 25% response at day 42 and at least 50% by Day 84" (NCT03816176)
Timeframe: Baseline up to days 42, 84 and EOT (180 days)

InterventionPercentage of partticipants (Number)
Day 42Day 84EOT
Isavuconazonium Sulfate29.025.854.8

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Percentage of Participants With Clinical Response: Investigator Assessment

"Investigator-assessed Clinical Response was defined as follows:~Success: if resolution of all attributable signs and symptoms or resolution of attributable clinical symptoms and physical findings~Failure: if no resolution of any attributable signs and symptoms or no resolution of any attributable signs and symptoms (no change) or worsening of any attributable signs and symptoms~Not Evaluable: if results not available /participant unevaluable or if no attributable signs and symptoms~No assessment: Those participants that do not fall under any of the above criteria" (NCT03816176)
Timeframe: Baseline up to days 42, 84 and EOT (180 days)

InterventionPercentage of participants (Number)
Day 42 SuccessDay 42 FailureDay 42 Not EvaluableDay 42 No AssessmentDay 84 SuccessDay 84 FailureDay 84 Not EvaluableDay 84 No AssessmentEOT SuccessEOT FailureEOT Not EvaluableEOT No Assessment
Isavuconazonium Sulfate41.99.7048.432.30067.761.329.03.26.5

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Number of Participants With Treatment Emergent Adverse Events (TEAEs)

"An AE is any untoward medical occurrence in a participant administered a study drug, which does not have to have a causal relationship with this treatment. It can be any unfavorable sign, symptom, or disease temporally associated with the use of a medicinal product.~TEAE is defined as an AE observed after starting administration of the study drug through 30 days after the last dose." (NCT03816176)
Timeframe: From first dose to 30 days after the last dose (maximum 210 Days)

InterventionParticipants (Number)
Isavuconazonium Sulfate29

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Percentage of Participants With Clinical Response: AC Assessment

"AC Assessed Clinical response was defined as follows:~Success: Complete (if resolution of all attributable clinical symptoms and physical findings occurs); Partial (if resolution of at least some of the clinical symptoms and physical findings associated with IFD)~Failure: Stable (if minor of no change in clinical symptoms and physical findings associated with IFD); Progression (if worsening or new clinical symptoms and physical findings associated with IFD, or if alternative systemic antifungal treatment is required)~Not Evaluable: If not assessed or no clinical signs or symptoms at baseline~No assessment: Those participants that do not fall under any of the above criteria" (NCT03816176)
Timeframe: Baseline up to days 42, 84 and EOT (180 days)

InterventionPercentage of participants (Number)
Day 42 SuccessDay 42 FailureDay 42 Not EvaluableDay 42 No AssessmentDay 84 SuccessDay 84 FailureDay 84 Not EvaluableDay 84 No AssessmentEOT SuccessEOT FailureEOT Not EvaluableEOT No Assessment
Isavuconazonium Sulfate0058.0641.940035.4864.526.459.6883.870

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Percentage of Participants With All - Cause Mortality

"EOT was defined as anytime from day 1 to a maximum of day 180. Data reported in the table below for each category, i.e., Day 84 represented data between Day 1 and Day 84 and for EOT, data represented between Day 1 to the EOT day for each individual. Participants who died after EOT assessment but before reaching Day 84 were included in the data for Day 84 category. Only those deaths that occurred after Day 84 would be included in EOT category if the death occurred during the treatment period (i.e. prior to the EOT)." (NCT03816176)
Timeframe: Baseline up to day 84 and end of treatment (EOT) (up to a maximum of 180 days) (Average duration of treatment: 57.7 days)

InterventionPercentage of participants (Number)
Day 84EOT
Isavuconazonium Sulfate9.70.00

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Percentage of Participants With All - Cause Mortality Through Day 42

All - Cause Mortality Through Day 42 (NCT03816176)
Timeframe: Baseline up to 42 days

InterventionPercentage of participants (Number)
Isavuconazonium Sulfate6.5

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Percentage of Participants With Radiological Response: AC Assessment

"AC-assessed Radiological Response was defined as follows:~Success: Complete (if ≥ 90% improvement); Partial (if at least < 25% response at day 42 and at least 50% response by Day 84)~Failure: Stable (if minor or no change in radiographic abnormalities associated with IFD, but no signs of progression); Progression (if worsening or new radiological abnormalities associated with IRD)~Not Evaluable: if no post baseline radiology available with baseline evidence of radiolical disease Or Radiology not applicable at baseline~No assessment: Those participants that do not fall under any of the above criteria" (NCT03816176)
Timeframe: Baseline up to days 42, 84 and EOT (180 days)

InterventionPercentage of participants (Number)
Day 42 SuccessDay 42 FailureDay 42 Not EvaluableDay 42 No AssessmentDay 84 SuccessDay 84 FailureDay 84 Not EvaluableDay 84 No AssessmentEOT SuccessEOT FailureEOT Not EvaluableEOT No Assessment
Isavuconazonium Sulfate29.036.4522.5841.9425.8109.6864.5251.6116.1332.260

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Percentage of Participants With Radiological Response: Investigator Assessment

"Investigator's assessed radiological response was defined as follows:~Success: if ≥ 90% improvement, ≥ 50% to < 90% improvement, ≥ 25% to 50% improvement (for Day 42 only)~Failure if < 25% improvement at any time or no signs or radiological Images~Not Evaluable if results not evaluable or no radiological data available~No assessment: Those participants that do not fall under any of the above criteria" (NCT03816176)
Timeframe: Baseline up to days 42, 84 and EOT (180 days)

InterventionPercentage of participants (Number)
Day 42 SuccessDay 42 FailureDay 42 Not EvaluableDay 42 No AssessmentDay 84 SuccessDay 84 FailureDay 84 Not EvaluableDay 84 No AssessmentEOT SuccessEOT FailureEOT Not EvaluableEOT No Assessment
Isavuconazonium Sulfate25.83.212.958.119.409.771.048.416.129.06.5

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Percentage of Participats With Mycological Response: Investigator Assessment

"Investigator's assessed mycological response was defined as follows:~Success: Eradicated (no growth of the original [at baseline] causative organism on culture or identified by histology/cytology on post baseline [after day 7] cultures and/or histology/cytology); Presumed Eradicated (missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding)~Failure: Persistence (persistence of the original causative organism cultured or identified by histological /cytology at baseline); Presumed Persistence (missing post baseline documentation of the persistence of the original causative organism at baseline PLUS no resolution or worsening of any clinical symptoms/physical findings)~Not Evaluable: Indeterminate/no mycological follow-up or results available~No assessment: Those participants that do not fall under any of the above criteria" (NCT03816176)
Timeframe: Baseline up to days 42, 84 and EOT (180 days)

InterventionPercentage of Participants (Number)
Day 42 SuccessDay 42 FailureDay 42 Not EvaluableDay 42 No AssessmentDay 84 SuccessDay 84 FailureDay 84 Not EvaluableDay 84 No AssessmentEOT SuccessEOT FailureEOT Not EvaluableEOT No Assessment
Isavuconazonium Sulfate22.66.522.648.425.803.271.045.212.935.56.5

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