tedizolid phosphate profile

tedizolid phosphate: a prodrug of DA-7157; structure in first source [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

tedizolid phosphate : A phosphate monoester resulting from the formal condensation of equimolar amounts of phosphoric acid with the hydroxy group of tedizolid . It is a prodrug of tedizolid, used for the treatment of acute bacterial skin infections caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. [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]

ID Source	ID
PubMed CID	11476460
CHEMBL ID	2105669
CHEBI ID	83326
SCHEMBL ID	1557561
MeSH ID	M0548441

Synonym
torezolid phosphate
tedizolid phosphate
chebi:83326 ,
bdbm50017198
tr-701-fa
856867-55-5
D09686
tedizolid phosphate (jan/usan)
sivextro (tn)
unii-o7drj6r4dw
sivextro
tr-701 fa
tedizolid phosphate [usan]
2-oxazolidinone, 3-(3-fluoro-4-(6-(2-methyl-2h-tetrazol-5-yl)-3-pyridinyl)phenyl)-5- ((phosphonooxy)methyl)-, (5r)-
o7drj6r4dw ,
((5r)-3-(3-fluoro-4-(6-(2-methyl-2h-tetrazol-5-yl)pyridin-3-yl)phenyl)-2-oxooxazolidin-5- yl)methyl hydrogen phosphate
da7218
CHEMBL2105669
tr-701fa
S4641
tedizolid phosphate [orange book]
[(5r)-3-{3-fluoro-4-[6-(2-methyl-2h-tetrazol-5-yl)pyridin-3-yl]phenyl}-2-oxooxazolidin-5-yl]methyl hydrogen phosphate
da-7218 free acid
tedizolid phosphate [mi]
tedizolid phosphate [jan]
tedizolid phosphate [vandf]
tr-701 free acid phosphate
tedizolid phosphate [who-dd]
2-oxazolidinone, 3-(3-fluoro-4-(6-(2-methyl-2h-tetrazol-5-yl)-3-pyridinyl)phenyl)-5-((phosphonooxy)methyl)-, (5r)-
[(5r)-3-{3-fluoro-4-[6-(2-methyl-2h-tetrazol-5-yl)pyridin-3-yl]phenyl}-2-oxo-1,3-oxazolidin-5-yl]methyl dihydrogen phosphate
CS-5004
DTXSID30234977 ,
SCHEMBL1557561
(r)-(3-(3-fluoro-4-(6-(2-methyl-2h-tetrazol-5-yl)pyridin-3-yl)phenyl)-2-oxooxazolidin-5-yl)methyl dihydrogen phosphate
tedizolid (phosphate)
HY-14855B
DB09042
AKOS027250820
mfcd28098176
(5r)-3-[3-fluoro-4-[6-(2-methyl-2h-tetrazol-5-yl)-3-pyridinyl]phenyl]-5-[(phosphonooxy)methyl]-2-oxazolidinone; tr 701fa; tedizolid hydrogen phosphate; tedizolid phosphate
NCGC00482851-02
856867-55-5 (phosphate)
Q21011227
tr701-fa; tr-701-fa; tr 701-fa
BCP10960
EX-A5792
tedizolid-phosphate
AMY9256
CCG-269233
tedizolidphosphate
[(5r)-3-[3-fluoro-4-[6-(2-methyltetrazol-5-yl)pyridin-3-yl]phenyl]-2-oxo-1,3-oxazolidin-5-yl]methyl dihydrogen phosphate
AS-57141
A863474
EN300-7407866
{[(5r)-3-{3-fluoro-4-[6-(2-methyl-2h-1,2,3,4-tetrazol-5-yl)pyridin-3-yl]phenyl}-2-oxo-1,3-oxazolidin-5-yl]methoxy}phosphonic acid
tr701
((5r)-3-(3-fluoro-4-(6-(2-methyl-2h-tetrazol-5-yl)pyridin-3-yl)phenyl)-2-oxo-1,3-oxazolidin-5-yl)methyl dihydrogen phosphate
((5r)-3-(3-fluoro-4-(6-(2-methyl-2h-tetrazol-5-yl)pyridin-3-yl)phenyl)-2-oxooxazolidin-5-yl)methyl hydrogen phosphate
dtxcid60157468
(5r)-(3-(3-fluoro-4-(6-(2-methyl-2h-tetrazol-5-yl)pyridin-3-yl)phenyl)-2-oxooxazolidin-5-yl)methyl dihydrogen phosphate

Research Excerpts

Overview

Tedizolid phosphate is a novel antibacterial prodrug that is rapidly and extensively converted to its active moiety, tedizolid. It has improved potency against Gram-positive pathogens and pharmacokinetics, allowing once-daily administration.

Excerpt	Reference	Relevance
"Tedizolid phosphate is an antibiotic prodrug that is metabolized into tedizolid which is used against various resistant bacterial strains. "	( Stability-Indicating Determination of Tedizolid Phosphate in the Presence of its Active Form and Possible Degradants. Abdel-Moety, EM; Fayed, AS; Moaaz, EM; Rezk, MR, 2022)	2.44
"Tedizolid phosphate is a novel oxazolidinone in development for the treatment of ABSSSIs."	( Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections: the ESTABLISH-1 randomized trial. Das, A; De Anda, C; Fang, E; Mehra, P; Prokocimer, P, 2013)	2.55
"Tedizolid phosphate is a novel oxazolidinone prodrug whose active moiety, tedizolid, has improved potency against Gram-positive pathogens and pharmacokinetics, allowing once-daily administration. "	( In vitro, in vivo, and clinical studies of tedizolid to assess the potential for peripheral or central monoamine oxidase interactions. Bartizal, K; Fang, E; Flanagan, S; Minassian, SL; Prokocimer, P, 2013)	1.83
"Tedizolid phosphate is a novel antibacterial prodrug with potent activity against Gram-positive pathogens. "	( Absorption, distribution, metabolism, and excretion of the novel antibacterial prodrug tedizolid phosphate. Bartizal, K; Dreskin, HJ; Fang, E; Flanagan, S; Locke, JB; Ong, V; Prokocimer, P, 2014)	2.07
"Tedizolid phosphate is a novel antibacterial under investigation for the treatment of gram-positive infections. "	( Single- and multiple-dose pharmacokinetics and absolute bioavailability of tedizolid. Fang, E; Flanagan, S; Minassian, SL; Muñoz, KA; Prokocimer, PG, 2014)	1.85
"Tedizolid phosphate is a novel antibacterial prodrug that is rapidly and extensively converted to its active moiety, tedizolid. "	( Tedizolid population pharmacokinetics, exposure response, and target attainment. Fiedler-Kelly, J; Flanagan, S; Lu, Q; Ludwig, E; Passarell, J; Prokocimer, P, 2014)	1.85
"Tedizolid phosphate is a novel oxazolidinone prodrug whose active moiety is tedizolid."	( Tedizolid phosphate for the treatment of acute bacterial skin and skin structure infections. Gras, J, 2014)	2.57
"Tedizolid phosphate is a novel oxazolidinone prodrug (converted to the active form tedizolid by phosphatases in vivo) that has been developed and recently approved (June 2014) by the United States FDA for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). "	( Tedizolid: a novel oxazolidinone with potent activity against multidrug-resistant gram-positive pathogens. Adam, H; Gilmour, M; Gin, AS; Golden, A; Gorityala, B; Hoban, DJ; Karlowsky, JA; Lagacé-Wiens, PR; Love, R; Lynch, JP; Rubinstein, E; Schweizer, F; Walkty, A; Zelenitsky, S; Zhanel, GG, 2015)	1.86
"Tedizolid phosphate is a second-generation oxazolidinone prodrug that is potential activity against a wide range of Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus, penicillin-resistant streptococci, and vancomycin-resistant enterococci. "	( In vitro activity of Tedizolid phosphate against multidrug-resistant Streptococcus pneumoniae isolates from Asian countries. Baek, JY; Chung, DR; Hsueh, PR; Kang, CI; Kim, SH; Ko, KS; Lee, NY; Peck, KR; So, TM; Song, JH; Thamlikitkul, V, 2016)	2.2
"Tedizolid phosphate is a new antibacterial agent under investigation for the treatment of Gram-positive infections in China. "	( Pharmacokinetics and Safety of Tedizolid after Single and Multiple Intravenous/Oral Sequential Administrations in Healthy Chinese Subjects. Chang, X; Chen, R; Hu, P; Li, L; Shen, K; Tanaka, T, 2016)	1.88
"Tedizolid phosphate (TR-701) is a novel oxazolidinone prodrug (converted to the active form tedizolid [TR-700]) with potent Staphylococcus aureus activity. "	( Comparative pharmacodynamics of the new oxazolidinone tedizolid phosphate and linezolid in a neutropenic murine Staphylococcus aureus pneumonia model. Andes, DR; Craig, WA; Lepak, AJ; Marchillo, K; Pichereau, S, 2012)	2.07

Effects

Excerpt	Reference	Relevance
"Tedizolid phosphate has been approved by the U.S."	( Tedizolid phosphate for the treatment of acute bacterial skin and skin structure infections. Gras, J, 2014)	2.57

Treatment

Excerpt	Reference	Relevance
"Tedizolid phosphate treatment was well tolerated by Latino patients in the safety population with lower abnormal platelet counts at end-of-therapy (tedizolid: 3.4% vs linezolid: 11.3%, p=0.0120) and lower incidence of gastrointestinal adverse events (tedizolid: 16.5% vs linezolid: 23.5%)."	( Efficacy, safety, tolerability and population pharmacokinetics of tedizolid, a novel antibiotic, in Latino patients with acute bacterial skin and skin structure infections. Cabré-Márquez, JF; Fang, E; Fiedler-Kelly, J; Flanagan, SD; Nannini, EC; Ortiz-Covarrubias, A; Passarell, J; Prokocimer, PG; Tanaka, T; Zhu, X, )	0.85

Toxicity

Both treatments were well tolerated; overall treatment-emergent adverse events (TEAEs) in tedizolid phosphate (79.5%) were low. In an effort to improve efficacy and safety, the adverse event profile and safety aspects have been evaluated in several preclinical animal models and through ongoing clinical trials.

Excerpt	Reference	Relevance
" TP was safe and well tolerated at all dose levels."	( Phase 2, randomized, double-blind, dose-ranging study evaluating the safety, tolerability, population pharmacokinetics, and efficacy of oral torezolid phosphate in patients with complicated skin and skin structure infections. Bien, P; Bulitta, JB; Corey, GR; DeAnda, C; Mehra, P; Prokocimer, P; Surber, J, 2011)	0.37
" In an effort to improve efficacy and safety, the adverse event profile and safety aspects of tedizolid phosphate have been evaluated in several preclinical animal models and through ongoing clinical trials."	( Tedizolid phosphate for the management of acute bacterial skin and skin structure infections: safety summary. Das, D; Fang, E; Mehra, P; Prokocimer, P; Tulkens, PM, 2014)	2.06
" Myelosuppression and monoamine oxidase inhibition (MAOI) are key independent causes for limiting adverse effects in therapy with the sole approved drug of this class, linezolid."	( New potent antibacterial oxazolidinone (MRX-I) with an improved class safety profile. Gordeev, MF; Yuan, ZY, 2014)	0.4
"Oxazolidinone pharmacology including structure-activity relationships, mode of action, pharmacokinetics, drug-drug interactions, and adverse drug reactions is reviewed."	( Drug-drug interactions and safety of linezolid, tedizolid, and other oxazolidinones. Douros, A; Grabowski, K; Stahlmann, R, 2015)	0.42
"0120) and lower incidence of gastrointestinal adverse events (tedizolid: 16."	( Efficacy, safety, tolerability and population pharmacokinetics of tedizolid, a novel antibiotic, in Latino patients with acute bacterial skin and skin structure infections. Cabré-Márquez, JF; Fang, E; Fiedler-Kelly, J; Flanagan, SD; Nannini, EC; Ortiz-Covarrubias, A; Passarell, J; Prokocimer, PG; Tanaka, T; Zhu, X, )	0.13
" Adverse events (AEs) were recorded throughout the entire study."	( Pharmacokinetics and Safety of Tedizolid after Single and Multiple Intravenous/Oral Sequential Administrations in Healthy Chinese Subjects. Chang, X; Chen, R; Hu, P; Li, L; Shen, K; Tanaka, T, 2016)	0.43
"In these 2 studies in healthy subjects, tedizolid administered for up to 21 days was not associated with drug-related ophthalmologic or neurologic adverse events."	( Characterization of Neurologic and Ophthalmologic Safety of Oral Administration of Tedizolid for Up to 21 Days in Healthy Volunteers. Fang, E; Muñoz, KA; Prokocimer, P, )	0.13
"Clinical adverse event (AE) and laboratory data were pooled across completed clinical studies (13 phase 1, two phase 2, and two phase 3), for all participants who received ≥1 dose of tedizolid 200 mg, linezolid 600 mg (phase 3 only), or placebo (phase 1 only)."	( Clinical safety and tolerability of tedizolid phosphate in the treatment of acute bacterial skin and skin structure infections. Anuskiewicz, S; Bidell, M; De Anda, C; Flanagan, S; Hardalo, C; Lodise, TP; Prokocimer, P, 2018)	0.76
" Both treatments were well tolerated; overall treatment-emergent adverse events (TEAEs) in tedizolid phosphate (79."	( Efficacy, safety and pharmacokinetics of tedizolid versus linezolid in patients with skin and soft tissue infections in Japan - Results of a randomised, multicentre phase 3 study. Iwamoto, Y; Kato, M; Kohno, S; Mikamo, H; Takesue, Y; Tanigawa, T; Tanimura, Y, 2018)	0.7

Pharmacokinetics

The absolute oral bioavailability of tedizolid after a single 200-mg dose was 91%; pharmacokinetic parameters of tedzolid were similar with oral and IV administration. The Cmax and AUC of tedZolid (the active moiety of tedziolid phosphate) were 3.

Excerpt	Reference	Relevance
" The pharmacokinetic parameters of DA-7218 and DA-7157 were evaluated after intravenous (5, 10 and 20 mg kg(-1)) and oral (20, 50 and 100 mg kg(-1)) administration of DA-7218 to rats."	( Pharmacokinetics of DA-7218, a new oxazolidinone, and its active metabolite, DA-7157, after intravenous and oral administration of DA-7218 and DA-7157 to rats. Bae, SK; Lee, MG; Rhee, JK; Shin, KN; Yang, SH; Yoo, M, 2007)	0.34
" Single-dose pharmacokinetic studies were conducted in mice for TR-701/700."	( In vivo pharmacodynamics of torezolid phosphate (TR-701), a new oxazolidinone antibiotic, against methicillin-susceptible and methicillin-resistant Staphylococcus aureus strains in a mouse thigh infection model. Drusano, GL; Kulawy, R; Liu, W; Louie, A, 2011)	0.37
" Tedizolid half-life values were approximately 2-fold greater compared with linezolid."	( Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Bien, PA; Flanagan, SD; Minassian, SL; Muñoz, KA; Prokocimer, PG, 2014)	0.4
"Overall, tedizolid has a favorable PK profile, a half-life that supports once daily administration, and no nonlinearities at steady state."	( Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Bien, PA; Flanagan, SD; Minassian, SL; Muñoz, KA; Prokocimer, PG, 2014)	0.4
"In the Staphylococcus aureus neutropenic murine thigh-infection model, the ratio of the free area under the 24-hour concentration-time curve to the minimum inhibitory concentration (fAUC/MIC) was found to be the pharmacodynamic index most closely linked to bacterial effect, with a ratio of approximately 50 producing a static effect."	( Use of pharmacokinetic/pharmacodynamic systems analyses to inform dose selection of tedizolid phosphate. Drusano, GL; Lodise, TP, 2014)	0.63
" The absolute oral bioavailability of tedizolid after a single 200-mg dose of tedizolid phosphate was 91%; pharmacokinetic parameters of tedizolid were similar with oral and IV administration."	( Single- and multiple-dose pharmacokinetics and absolute bioavailability of tedizolid. Fang, E; Flanagan, S; Minassian, SL; Muñoz, KA; Prokocimer, PG, 2014)	0.63
" Preclinical and early clinical studies have reported positive results, demonstrating a favorable pharmacokinetic profile in combination with key potential safety advantages."	( Early experience with tedizolid: clinical efficacy, pharmacodynamics, and resistance. Martin, CA; Marx, K; Rybak, JM, 2014)	0.4
" Population pharmacokinetic analysis suggested that estimated tedizolid exposure measures in Latino patients vs non-Latino patients were similar."	( Efficacy, safety, tolerability and population pharmacokinetics of tedizolid, a novel antibiotic, in Latino patients with acute bacterial skin and skin structure infections. Cabré-Márquez, JF; Fang, E; Fiedler-Kelly, J; Flanagan, SD; Nannini, EC; Ortiz-Covarrubias, A; Passarell, J; Prokocimer, PG; Tanaka, T; Zhu, X, )	0.13
" This study was conducted to assess the pharmacokinetic (PK) properties, oral bioavailability, and safety of once daily tedizolid phosphate 200 mg in Chinese subjects to support its further clinical development in China."	( Pharmacokinetics and Safety of Tedizolid after Single and Multiple Intravenous/Oral Sequential Administrations in Healthy Chinese Subjects. Chang, X; Chen, R; Hu, P; Li, L; Shen, K; Tanaka, T, 2016)	0.64
" The pharmacokinetic parameters of tedizolid after a single dose were similar in both age groups."	( Pharmacokinetics, Safety, and Tolerability of Tedizolid Phosphate in Elderly Subjects. Flanagan, SD; Minassian, SL; Prokocimer, P, 2018)	0.74
" The tedizolid mean terminal half-life was 5-6 hours and 6-7 hours for the intravenous and oral administration groups, respectively."	( Pharmacokinetics and Safety of Single-dose Tedizolid Phosphate in Children 2 to <12 Years of Age. Ang, JY; Arrieta, AC; Bradley, JS; Chou, MZ; De Anda, CS; Espinosa, C; Fofanov, O; Kim, JY; Li, D; Sabato, P; Sears, PS; Tøndel, C, 2021)	0.88

Compound-Compound Interactions

Excerpt	Reference	Relevance
"Oxazolidinone pharmacology including structure-activity relationships, mode of action, pharmacokinetics, drug-drug interactions, and adverse drug reactions is reviewed."	( Drug-drug interactions and safety of linezolid, tedizolid, and other oxazolidinones. Douros, A; Grabowski, K; Stahlmann, R, 2015)	0.42

Bioavailability

Study TR701-108 was a relative bioavailability study in 12 subjects. The absolute oral bioavailability of tedizolid after a single 200-mg dose was 91%. pharmacokinetic parameters of tedzolid were similar with oral and IV administration.

Excerpt	Reference	Relevance
" The relative bioavailability of TPD to the free acid tedizolid phosphate was determined to bridge the results of these and other studies to the solid form of the prodrug selected for further development."	( Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Bien, PA; Flanagan, SD; Minassian, SL; Muñoz, KA; Prokocimer, PG, 2014)	0.65
"Randomized placebo-controlled, double-blind single- and multiple-ascending dose studies and randomized open-label, crossover food effect and relative bioavailability studies."	( Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Bien, PA; Flanagan, SD; Minassian, SL; Muñoz, KA; Prokocimer, PG, 2014)	0.4
" Study TR701-108 was a relative bioavailability study in 12 subjects administered 150-mg tedizolid equivalents as TPD or tedizolid phosphate."	( Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Bien, PA; Flanagan, SD; Minassian, SL; Muñoz, KA; Prokocimer, PG, 2014)	0.61
" This study was conducted to assess the pharmacokinetics, safety, and tolerability of intravenous tedizolid phosphate as well as the oral bioavailability of tedizolid phosphate."	( Single- and multiple-dose pharmacokinetics and absolute bioavailability of tedizolid. Fang, E; Flanagan, S; Minassian, SL; Muñoz, KA; Prokocimer, PG, 2014)	0.62
" The absolute oral bioavailability of tedizolid after a single 200-mg dose of tedizolid phosphate was 91%; pharmacokinetic parameters of tedizolid were similar with oral and IV administration."	( Single- and multiple-dose pharmacokinetics and absolute bioavailability of tedizolid. Fang, E; Flanagan, S; Minassian, SL; Muñoz, KA; Prokocimer, PG, 2014)	0.63
"4% coefficient of variation), and absolute bioavailability was high (86%)."	( Tedizolid population pharmacokinetics, exposure response, and target attainment. Fiedler-Kelly, J; Flanagan, S; Lu, Q; Ludwig, E; Passarell, J; Prokocimer, P, 2014)	0.4
" It demonstrates linear pharmacokinetics, has a high oral bioavailability of approximately 90 %, and is primarily excreted by the liver as an inactive, non-circulating sulphate conjugate."	( Tedizolid: a novel oxazolidinone with potent activity against multidrug-resistant gram-positive pathogens. Adam, H; Gilmour, M; Gin, AS; Golden, A; Gorityala, B; Hoban, DJ; Karlowsky, JA; Lagacé-Wiens, PR; Love, R; Lynch, JP; Rubinstein, E; Schweizer, F; Walkty, A; Zelenitsky, S; Zhanel, GG, 2015)	0.42
" Absolute oral bioavailability of tedizolid (90% confidence interval) was 88."	( Pharmacokinetics, Safety and Tolerability of Single Oral or Intravenous Administration of 200 mg Tedizolid Phosphate in Adolescents. Arrieta, AC; Bradley, JS; Capparelli, E; Flanagan, SD; Jacobs, R; Prokocimer, P, 2016)	0.65
"Overall pharmacokinetics of tedizolid was similar after administration of a single oral or IV 200 mg dose, and bioavailability was high."	( Pharmacokinetics, Safety and Tolerability of Single Oral or Intravenous Administration of 200 mg Tedizolid Phosphate in Adolescents. Arrieta, AC; Bradley, JS; Capparelli, E; Flanagan, SD; Jacobs, R; Prokocimer, P, 2016)	0.65
" The oral bioavailability of tedizolid was 85."	( Pharmacokinetics and Safety of Tedizolid after Single and Multiple Intravenous/Oral Sequential Administrations in Healthy Chinese Subjects. Chang, X; Chen, R; Hu, P; Li, L; Shen, K; Tanaka, T, 2016)	0.43
"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
" The increased bioavailability and reduced drug resistance of antibiotics are crucial to obtain a more effective treatment response in these infections."	( Radiolabeled Tedizolid Phosphate Liposomes for Topical Application: Design, Characterization, and Evaluation of Cellular Binding Capacity. Atlihan-Gundogdu, E; Demir, ES; Karpuz, M; Senyigit, Z, 2021)	0.99
" The oral tedizolid phosphate suspension demonstrated high bioavailability comparable to that of the parenteral administration."	( Pharmacokinetics and Safety of Single-dose Tedizolid Phosphate in Children 2 to <12 Years of Age. Ang, JY; Arrieta, AC; Bradley, JS; Chou, MZ; De Anda, CS; Espinosa, C; Fofanov, O; Kim, JY; Li, D; Sabato, P; Sears, PS; Tøndel, C, 2021)	1.29
"Many lead compounds fail to reach clinical trials despite being potent because of low bioavailability attributed to their insufficient solubility making solubility a primary and crucial factor in early phase drug discovery."	( Structural modification aimed for improving solubility of lead compounds in early phase drug discovery. Baidya, ATK; Das, B; Kumar, R; Mathew, AT; Yadav, AK, 2022)	0.72

Dosage Studied

The results of this Phase I study conducted in Chinese male subjects indicate that no dosage adjustment would be required when switching administration routes. Preclinical and phase 1 trials have shown that 200-mg once-daily tedizolid phosphate dosing achieves the appropriate pharmacokinetic goals for optimal antimicrobial effect.

Excerpt	Relevance	Reference
" Dose fractionation studies showed that AUC/MIC was the pharmacodynamic index linked with efficacy, indicating that once-daily dosing in humans is feasible."	( In vivo pharmacodynamics of torezolid phosphate (TR-701), a new oxazolidinone antibiotic, against methicillin-susceptible and methicillin-resistant Staphylococcus aureus strains in a mouse thigh infection model. Drusano, GL; Kulawy, R; Liu, W; Louie, A, 2011)	0.37
" Given that the clinical and microbiological efficacy are similar for the 200, 300, and 400 mg doses, the lowest effective dose of 200 mg once daily for 6 days was selected for Phase III studies in acute bacterial skin and skin-structure infections, providing a safe dosing regimen with low potential for development of myelosuppression."	( Potential role of tedizolid phosphate in the treatment of acute bacterial skin infections. Espona, M; Ferrández, I; Ferrández, O; Grau, S; Salas, E; Urbina, O, 2013)	0.72
" The observations from these studies support once daily dosing of tedizolid phosphate and highlight important metabolism and excretion features that differentiate tedizolid phosphate from linezolid."	( Absorption, distribution, metabolism, and excretion of the novel antibacterial prodrug tedizolid phosphate. Bartizal, K; Dreskin, HJ; Fang, E; Flanagan, S; Locke, JB; Ong, V; Prokocimer, P, 2014)	0.86
"These results from a population of healthy volunteers support once/day dosing of tedizolid phosphate 200 mg with both the oral and IV formulations, without the need for dose adjustment when switching administration routes."	( Single- and multiple-dose pharmacokinetics and absolute bioavailability of tedizolid. Fang, E; Flanagan, S; Minassian, SL; Muñoz, KA; Prokocimer, PG, 2014)	0.63
" With its half-life of approximately 12 h, tedizolid is dosed once daily."	( Tedizolid: a novel oxazolidinone with potent activity against multidrug-resistant gram-positive pathogens. Adam, H; Gilmour, M; Gin, AS; Golden, A; Gorityala, B; Hoban, DJ; Karlowsky, JA; Lagacé-Wiens, PR; Love, R; Lynch, JP; Rubinstein, E; Schweizer, F; Walkty, A; Zelenitsky, S; Zhanel, GG, 2015)	0.42
"Tedizolid phosphate is the second commercially available oxazolidinone antibiotic, although the first one in class that is dosed once daily."	( Tedizolid: The First Once-Daily Oxazolidinone Class Antibiotic. Burdette, SD; Trotman, R, 2015)	1.86
" Peak plasma concentration of tedizolid is obtained within 3 h of oral dosing (PO), with high bioavailability."	( Tedizolid for treatment of acute bacterial skin and skin structure infections. Hui, Y; Xiaoju, L, 2015)	0.42
" Dalbavancin and oritavancin have a long half-life and can be dosed less frequently."	( Current and future trends in antibiotic therapy of acute bacterial skin and skin-structure infections. Bassetti, M; Concia, E; Cristini, F; De Rosa, FG; Esposito, S; Menichetti, F; Petrosillo, N; Russo, A; Tumbarello, M; Venditti, M; Viale, P; Viscoli, C, 2016)	0.43
" Blood samples were collected for up to 72 hours after single dosing and for up to 2 hours on Day 3 and 72 hours on Day 7 of multiple dosing to determine PK parameters."	( Pharmacokinetics and Safety of Tedizolid after Single and Multiple Intravenous/Oral Sequential Administrations in Healthy Chinese Subjects. Chang, X; Chen, R; Hu, P; Li, L; Shen, K; Tanaka, T, 2016)	0.43
"The results of this Phase I study conducted in Chinese male subjects indicate that no dosage adjustment of tedizolid phosphate 200 mg would be required when switching administration routes in this population."	( Pharmacokinetics and Safety of Tedizolid after Single and Multiple Intravenous/Oral Sequential Administrations in Healthy Chinese Subjects. Chang, X; Chen, R; Hu, P; Li, L; Shen, K; Tanaka, T, 2016)	0.65
" We evaluated the pharmacokinetics of tedizolid in elderly subjects to guide dosing recommendations."	( Pharmacokinetics, Safety, and Tolerability of Tedizolid Phosphate in Elderly Subjects. Flanagan, SD; Minassian, SL; Prokocimer, P, 2018)	0.74

[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Role	Description
antimicrobial agent	A substance that kills or slows the growth of microorganisms, including bacteria, viruses, fungi and protozoans.
protein synthesis inhibitor	A compound, usually an anti-bacterial agent or a toxin, which inhibits the synthesis of a protein.
prodrug	A compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
[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]

Class	Description
carbamate ester	Any ester of carbamic acid or its N-substituted derivatives.
organofluorine compound	An organofluorine compound is a compound containing at least one carbon-fluorine bond.
oxazolidinone	An oxazolidine containing one or more oxo groups.
pyridines	Any organonitrogen heterocyclic compound based on a pyridine skeleton and its substituted derivatives.
tetrazoles	An azole in which the five-membered heterocyclic aromatic skeleton contains four N atoms and one C atom.
phosphate monoester	An organic phosphate that is phosphoric acid in which one of the hydrogens is replaced by an organyl group.
[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]

Assay ID	Title	Year	Journal	Article
AID1346987	P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen	2019	Molecular pharmacology, 11, Volume: 96, Issue:5	A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1296008	Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening	2020	SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1	Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986	P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen	2019	Molecular pharmacology, 11, Volume: 96, Issue:5	A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347160	Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors	2020	Proceedings 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.
AID1347159	Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay	2020	Proceedings 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.
AID1151709	Myelosuppression activity against human CD34-positive blood stem/progenitor cells assessed as growth inhibition after 9 to 10 days by CellTiter-Glo luminescent assay	2014	Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11	New potent antibacterial oxazolidinone (MRX-I) with an improved class safety profile.
AID1151706	Inhibition of human recombinant MAO-A expressed in yeast after 1 hr by luciferin-based luminescence assay	2014	Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11	New potent antibacterial oxazolidinone (MRX-I) with an improved class safety profile.
AID1866020	Thermodynamic aqueous solubility of the compound	2022	Bioorganic & medicinal chemistry, 02-15, Volume: 56	Structural modification aimed for improving solubility of lead compounds in early phase drug discovery.
AID1288436	Half life in patient at 200 mg, po or iv administered once daily	2016	Bioorganic & medicinal chemistry, May-01, Volume: 24, Issue:9	Synthetic approaches to the 2014 new drugs.
AID1151710	Antibacterial activity against methicillin-resistant Staphylococcus aureus	2014	Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11	New potent antibacterial oxazolidinone (MRX-I) with an improved class safety profile.
AID1288435	Oral bioavailability in patient at 200 mg administered once daily	2016	Bioorganic & medicinal chemistry, May-01, Volume: 24, Issue:9	Synthetic approaches to the 2014 new drugs.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	4 (3.57)	29.6817
2010's	98 (87.50)	24.3611
2020's	10 (8.93)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	24 (20.87%)	5.53%
Reviews	24 (20.87%)	6.00%
Case Studies	1 (0.87%)	4.05%
Observational	0 (0.00%)	0.25%
Other	66 (57.39%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (28)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase 1, Open-Label, Multi-Center, Two-Part, Single-Dose, Parallel Design, Safety, Tolerance, and Pharmacokinetic Study of Orally and Intravenously Administered TR-701 FA in 12 to 17 Year Old Adolescent Patients [NCT01156077]	Phase 1	20 participants (Actual)	Interventional	2010-06-02	Completed
English Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal [NCT03746327]	Phase 4	20 participants (Anticipated)	Interventional	2020-03-01	Not yet recruiting
A Phase III Randomized, Active-comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator, in Subjects From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infectio [NCT03176134]	Phase 3	100 participants (Actual)	Interventional	2019-01-20	Completed
An Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Sequence, Crossover, Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of TR-701 (Torezolid Phosphate) in Normal Healthy Adults [NCT00876655]	Phase 1	12 participants (Actual)	Interventional	2009-02-28	Completed
A Phase 1, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to <12 Years Old [NCT02750761]	Phase 1	32 participants (Actual)	Interventional	2016-05-02	Completed
A Block-randomized, Double-blind, Placebo-controlled, Single-dose, Phase I Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of DA-7218 in Healthy Male Volunteers [NCT02097043]	Phase 1	31 participants (Actual)	Interventional	2014-05-31	Completed
A Double-Blind, Placebo-Controlled, Single & Multiple Ascending Dose, Safety, Tolerability, & PK Study of an IV Form of TR-701 Free Acid & an Open-Label, Crossover Absolute BA Determination of a TR-701 FA Tablet in Normal Healthy Adults [NCT00983255]	Phase 1	90 participants (Actual)	Interventional	2009-09-30	Completed
A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of 6-Day Oral TR-701 Free Acid and 10-Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections [NCT01170221]	Phase 3	667 participants (Actual)	Interventional	2010-08-15	Completed
An Open Label, Single Dose, Microdialysis and Pharmacokinetic Study of TR-701 in Normal Healthy Adults [NCT00666601]	Phase 1	15 participants (Actual)	Interventional	2008-04-04	Completed
An Open-Label, Single-Dose, Two-Treatment, Randomized, Two-Way Crossover, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults in the Fed and Fasted State [NCT00671359]	Phase 1	12 participants (Actual)	Interventional	2008-03-10	Completed
A Phase 2 Multi-Center, Randomized, Double-Blind, Non-Controlled Study Comparing the Safety, Tolerance, and Efficacy of TR-701 in Patients With Complicated Skin and Skin Structure Infections [NCT00761215]	Phase 2	192 participants (Actual)	Interventional	2008-09-17	Completed
Tolerability, Safety, and Efficacy of Tedizolid as Oral Treatment for Bone and Joint Infections [NCT03009045]	Phase 2	44 participants (Actual)	Interventional	2017-02-06	Completed
Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis [NCT05534750]	Phase 2	60 participants (Anticipated)	Interventional	2023-04-20	Recruiting
A Phase 1 Open-Label Study With Oral TR-701 FA to Assess Pharmacokinetics and Safety in Subjects With Moderate or Severe Hepatic Impairment [NCT01431833]	Phase 1	32 participants (Actual)	Interventional	2011-08-31	Completed
A Phase 1, Single- and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old [NCT03217565]	Phase 1	47 participants (Actual)	Interventional	2019-02-06	Completed
A Phase 1, Blinded, Placebo-Controlled, Crossover TR-701 FA Study of Blood Pressure Response Post-Tyramine Challenge [NCT01539473]	Phase 1	30 participants (Actual)	Interventional	2012-02-29	Completed
"DART: Sivextro® in Acute Bacterial Skin anD Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global ObseRvational STudy." [NCT02991131]		108 participants (Actual)	Observational	2016-12-17	Terminated(stopped due to Company decision)
A Phase 1 Open-Label Study With Oral TR-701 Free Acid to Assess Pharmacokinetics, Safety, and Tolerability in Elderly Subjects [NCT01496677]	Phase 1	28 participants (Actual)	Interventional	2012-01-17	Completed
Phase 1, Open-Label, Ophthalmology and Neurology Safety Study of Oral 200 mg TR-701 FA Once Daily for 10 Days in Healthy Adults [NCT01623401]	Phase 1	72 participants (Actual)	Interventional	2012-05-17	Completed
Single Dose Pharmacokinetics of Intravenous Tedizolid Phosphate in Morbidly Obese and Age-, Sex-, and Ideal Body Weight-Matched Non-Obese Adults [NCT02342418]	Phase 4	19 participants (Actual)	Interventional	2015-03-31	Completed
A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram [NCT01461460]	Phase 1	48 participants (Actual)	Interventional	2011-11-28	Completed
A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA [NCT01577459]	Phase 1	18 participants (Actual)	Interventional	2012-04-23	Completed
A Phase I Open-Label Study With 200 mg Intravenous TR-701 Free Acid to Assess Safety and Pharmacokinetics in Advanced Renal Impairment Subjects [NCT01452828]	Phase 1	24 participants (Actual)	Interventional	2011-10-31	Completed
A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia [NCT02019420]	Phase 3	726 participants (Actual)	Interventional	2014-01-06	Completed
Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg TR-701 Free Acid in Healthy Volunteers [NCT01271998]	Phase 1	20 participants (Actual)	Interventional	2010-12-08	Completed
A Prospective, Randomized, Open-label, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of BAY 1192631 in Japanese Patients With MRSA Infections (Skin and Soft Tissue Infection [SSTI] and SSTI-related Bacteremia) [NCT01967225]	Phase 3	125 participants (Actual)	Interventional	2013-11-23	Completed
A Multiple-Dose Study to Evaluate the Effects of Steady-State Tedizolid Phosphate Administration on the Pharmacokinetics and Safety of a Single Dose of Midazolam and Rosuvastatin [NCT02477514]	Phase 1	18 participants (Actual)	Interventional	2015-06-30	Completed
Prospective Cohort Study on Patients With Tedizolid Prolonged Therapy for Orthopedic Device Infections [NCT03378427]		35 participants (Actual)	Interventional	2018-08-28	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00761215 (6) [back to overview]	Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set
NCT00761215 (6) [back to overview]	Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set
NCT00761215 (6) [back to overview]	Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set
NCT00761215 (6) [back to overview]	Response Rate at End of Therapy
NCT00761215 (6) [back to overview]	Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set
NCT00761215 (6) [back to overview]	Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set
NCT01170221 (8) [back to overview]	Investigator's Assessment of Clinical Response at the 48-72 Hour Visit
NCT01170221 (8) [back to overview]	Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit
NCT01170221 (8) [back to overview]	To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set
NCT01170221 (8) [back to overview]	Change From Baseline in Patient-reported Pain, by Study Visit
NCT01170221 (8) [back to overview]	Investigator's Assessment of Clinical Response at the Day 7 Visit
NCT01170221 (8) [back to overview]	Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets
NCT01170221 (8) [back to overview]	Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.
NCT01170221 (8) [back to overview]	Early Clinical Response Rate
NCT01967225 (6) [back to overview]	Microbiological Response at Test of Cure (TOC)
NCT01967225 (6) [back to overview]	Microbiological Response at End of Treatment (EOT)
NCT01967225 (6) [back to overview]	Clinical Response at Test of Cure (TOC)
NCT01967225 (6) [back to overview]	Clinical Response at End of Treatment Visit (EOT)
NCT01967225 (6) [back to overview]	Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI])
NCT01967225 (6) [back to overview]	Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI])
NCT02019420 (12) [back to overview]	Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population
NCT02019420 (12) [back to overview]	Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (mITT) Population
NCT02019420 (12) [back to overview]	Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiologically-Evaluable 2 (ME-2) Population
NCT02019420 (12) [back to overview]	Number of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population
NCT02019420 (12) [back to overview]	Number of Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population
NCT02019420 (12) [back to overview]	Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population
NCT02019420 (12) [back to overview]	Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population
NCT02019420 (12) [back to overview]	Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiologically-Evaluable 1 (ME-1) Population
NCT02019420 (12) [back to overview]	Number of Methicillin-Resistant Staphylococcus Aureus (MRSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population
NCT02019420 (12) [back to overview]	Number of Methicillin-Susceptible Staphylococcus Aureus (MSSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population
NCT02019420 (12) [back to overview]	Number of Participants Discontinuing Study Therapy Due to an Adverse Event (AE)
NCT02019420 (12) [back to overview]	Number of Participants With ≥1 Adverse Events (AEs)
NCT02342418 (2) [back to overview]	This Outcome Measure is the Maximum Plasma Concentration of Tedizolid in Morbidly Obese Subjects Compared to Nonobese Subjects
NCT02342418 (2) [back to overview]	This Outcome Measure is the Tedizolid Area Under the Concentration Time-curve From Time 0 to 72 Hours in Morbidly Obese Subjects and Matched Non-obese Subjects.
NCT02750761 (17) [back to overview]	Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity
NCT02750761 (17) [back to overview]	Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Last Detectable Measurement
NCT02750761 (17) [back to overview]	Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Infinity
NCT02750761 (17) [back to overview]	Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Last Detectable Measurement
NCT02750761 (17) [back to overview]	Clearance (CL) of Tedizolid (Active Metabolite) in Participants Who Received Tedizolid Phosphate Intravenously (IV)
NCT02750761 (17) [back to overview]	Clearance (CL) of Tedizolid Phosphate (Prodrug) in Participants Who Received Tedizolid Phosphate Intravenously (IV)
NCT02750761 (17) [back to overview]	Clearance (CL/F) of Tedizolid Phosphate in Participants Who Received Oral Tedizolid Phosphate (Prodrug)
NCT02750761 (17) [back to overview]	Terminal Elimination Half-life (T1/2) of Tedizolid (Active Metabolite)
NCT02750761 (17) [back to overview]	Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid Phosphate (Prodrug)
NCT02750761 (17) [back to overview]	Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid (the Active Metabolite)
NCT02750761 (17) [back to overview]	Clearance (CL/F) of Tedizolid (Active Metabolite) in Participants Who Received Oral Tedizolid Phosphate
NCT02750761 (17) [back to overview]	Number of Participants Who Experienced at Least One Adverse Event
NCT02750761 (17) [back to overview]	Number of Participants Who Discontinued Study Drug Due to an Adverse Event
NCT02750761 (17) [back to overview]	Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid Phosphate (Prodrug)
NCT02750761 (17) [back to overview]	Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid (the Active Metabolite)
NCT02750761 (17) [back to overview]	Dose Normalized Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity
NCT02750761 (17) [back to overview]	Terminal Elimination Half-life (T1/2) of Tedizolid Phosphate (Prodrug)
NCT03009045 (3) [back to overview]	"Number of Participants With an Outcome of Cure as Defined as no Need for Further Antibiotics Beyond the Originally Planned Duration Determined by the Participant's Primary/Treating Physician."
NCT03009045 (3) [back to overview]	Quantify the Safety of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated
NCT03009045 (3) [back to overview]	Quantify the Tolerability of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated

Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set

Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required. (NCT00761215)
Timeframe: 7 to 14 days after the last dose of study drug

Intervention	Percentage of participants (Number)
TR-701 200 mg	98.2
TR-701 300 mg	94.4
TR-701 400 mg	94.4

Intervention	units on a scale (Mean)
	Day 2	Day 4-6	Day 7-9	Day 10-13
Linezolid	-1.5	-3.1	-4.6	-5.5
Tedizolid Phosphate	-1.3	-3.4	-4.5	-5.3

Intervention	Percentage of participants (Number)
	Eradication	Persistence	Elimination(indeterminate)	Missing
Linezoid - Bacteremia	100.0	0.0	0.0	0.0
Linezoid - SSTI	90.0	0.0	0.0	10.0
Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI	93.1	3.4	0.0	3.4

Intervention	Percentage of participants (Number)
	Eradication	Persistence	Elimination (indeterminate)
Linezoid - Bacteremia	100.0	0.0	0.0
Linezoid - SSTI	100.0	0.0	0.0
Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI	93.1	6.9	0.0

Intervention	Percentage of participants (Number)
	Clinical cure	Clinical failure	Indeterminate
Linezoid - Bacteremia	0.0	0.0	100.0
Linezoid - SSTI	80.0	10.0	10.0
Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI	86.2	6.9	6.9

Intervention	Percentage of participants (Number)
	Effective	Ineffective	Indeterminate
Linezoid - Bacteremia	50.0	0.0	50.0
Linezoid - SSTI	90.0	10.0	0.0
Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI	93.1	6.9	0.0

Intervention	cm^2 (Mean)
	Day 3/4	Day 5 to 13	End of treatment	Test of cure (n=28, 9)
Linezoid - SSTI	-173.93	-317.66	-280.69	-314.18
Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI	-62.05	-134.31	-174.96	-212.63

Intervention	Percentage (Mean)
	Day3/4	Day 5 to 13	End of Treatment	Test of Cure
Linezoid - SSTI	-61.46	-94.61	-90.09	-99.09
Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI	-32.32	-53.30	-67.69	-81.82

Intervention	Participants (Count of Participants)
	Clinical Success	Clinical Failure	Indeterminate
Linezolid	146	97	0
Tedizolid	143	124	0

Intervention	hr*ng/mL (Geometric Least Squares Mean)
Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)	29600
Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)	21000
Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years)	27300
Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years)	17300
Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)	24900
Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)	17200

Intervention	hr*ng/mL (Geometric Least Squares Mean)
Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)	28200
Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)	19700
Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years)	26800
Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years)	17100
Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)	22700
Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)	14600

Intervention	hr*ng/mL (Geometric Least Squares Mean)
Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)	64.8
Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)	63.6
Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years)	433
Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years)	182
Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)	NA
Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)	14.1

Intervention	mL/hr (Geometric Mean)
Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)	4164.60
Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)	4145.73
Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years)	2582.66
Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years)	2461.08

Intervention	Hours (Geometric Mean)
Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)	5.18
Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)	4.93
Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years)	5.51
Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years)	5.76
Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)	6.15
Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)	6.79

Intervention	Hours (Median)
Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)	1.18
Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)	1.10
Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years)	1.12
Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years)	1.02
Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)	NA
Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)	6.0

Intervention	mL/hr/kg (Geometric Mean)
Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)	4073.32
Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)	2090.77

Intervention	ng/mL (Geometric Least Squares Mean)
Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)	76.3
Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)	82.4
Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years)	710
Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years)	234
Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)	NA
Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)	9.4

Intervention	ng/mL (Geometric Least Squares Mean)
Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)	4960
Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)	4140
Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years)	7460
Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years)	4190
Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)	2590
Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)	1820

Intervention	participants (Number)
	High leukocytes	Low leukocytes	Low hemoglobin	Low plateltes	High AST	High ALT	High ALP
Drug: 200mg Oral Tedizolid	0	0	0	0	0	0	0

Intervention	participants (Number)
	Reported peripheral neuropathy	Reported optic neuropathy
Drug: 200mg Oral Tedizolid	0	0

Condition	Indicated	Relationship Strength	Studies	Trials
Blood Poisoning [description not available]	0	3.43	2	0
Bacterial Infections, Gram-Positive [description not available]	0	10.37	20	2
Gram-Positive Bacterial Infections Infections caused by bacteria that retain the crystal violet stain (positive) when treated by the gram-staining method.	1	12.37	20	2
Sepsis Systemic inflammatory response syndrome with a proven or suspected infectious etiology. When sepsis is associated with organ dysfunction distant from the site of infection, it is called severe sepsis. When sepsis is accompanied by HYPOTENSION despite adequate fluid infusion, it is called SEPTIC SHOCK.	0	3.43	2	0
Congenital Zika Syndrome [description not available]	0	2.25	1	0
Disease Models, Animal Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.	0	5.28	11	0
Zika Virus Infection A viral disease transmitted by the bite of AEDES mosquitoes infected with ZIKA VIRUS. Its mild DENGUE-like symptoms include fever, rash, headaches and ARTHRALGIA. The viral infection during pregnancy, in rare cases, is associated with congenital brain and ocular abnormalities, called Congenital Zika Syndrome, including MICROCEPHALY and may also lead to GUILLAIN-BARRE SYNDROME.	0	2.25	1	0
Bacterial Skin Diseases [description not available]	0	15.77	43	21
Skin Diseases, Bacterial Skin diseases caused by bacteria.	0	15.77	43	21
Bacterial Pneumonia [description not available]	0	10.15	3	1
Pneumonia, Bacterial Inflammation of the lung parenchyma that is caused by bacterial infections.	0	5.15	3	1
Bacterial Disease [description not available]	0	9.33	7	5
Infections, Staphylococcal [description not available]	0	7.64	14	0
Bacterial Infections Infections by bacteria, general or unspecified.	1	11.33	7	5
Staphylococcal Infections Infections with bacteria of the genus STAPHYLOCOCCUS.	0	7.64	14	0
Arthropathies [description not available]	0	2.15	1	0
Joint Diseases Diseases involving the JOINTS.	0	2.15	1	0
Osteomyelitis INFLAMMATION of the bone as a result of infection. It may be caused by a variety of infectious agents, especially pyogenic (PUS - producing) BACTERIA.	0	2.54	2	0
Disease, Pulmonary [description not available]	0	2.55	2	0
Infection, Mycobacterium avium-intracellulare [description not available]	0	2.55	2	0
Lung Diseases Pathological processes involving any part of the LUNG.	0	2.55	2	0
Mycobacterium avium-intracellulare Infection A nontuberculous infection when occurring in humans. It is characterized by pulmonary disease, lymphadenitis in children, and systemic disease in AIDS patients. Mycobacterium avium-intracellulare infection of birds and swine results in tuberculosis.	0	2.55	2	0
Atypical Mycobacterial Infection, Disseminated [description not available]	0	2.15	1	0
Experimental Lung Inflammation Inflammation of any part, segment or lobe, of the lung parenchyma.	0	2.53	2	0
Pneumonia Infection of the lung often accompanied by inflammation.	1	4.53	2	0
Acute Disease Disease having a short and relatively severe course.	0	7.74	7	1
Infections, Soft Tissue [description not available]	0	7.01	6	2
Bacteremia The presence of viable bacteria circulating in the blood. Fever, chills, tachycardia, and tachypnea are common acute manifestations of bacteremia. The majority of cases are seen in already hospitalized patients, most of whom have underlying diseases or procedures which render their bloodstreams susceptible to invasion.	0	3.56	1	1
Soft Tissue Infections Infections of non-skeletal tissue, i.e., exclusive of bone, ligaments, cartilage, and fibrous tissue. The concept is usually referred to as skin and soft tissue infections and usually subcutaneous and muscle tissue are involved. The predisposing factors in anaerobic infections are trauma, ischemia, and surgery. The organisms often derive from the fecal or oral flora, particularly in wounds associated with intestinal surgery, decubitus ulcer, and human bites. (From Cecil Textbook of Medicine, 19th ed, p1688)	0	7.01	6	2
Cystic Fibrosis of Pancreas [description not available]	0	2.17	1	0
Cystic Fibrosis An autosomal recessive genetic disease of the EXOCRINE GLANDS. It is caused by mutations in the gene encoding the CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR expressed in several organs including the LUNG, the PANCREAS, the BILIARY SYSTEM, and the SWEAT GLANDS. Cystic fibrosis is characterized by epithelial secretory dysfunction associated with ductal obstruction resulting in AIRWAY OBSTRUCTION; chronic RESPIRATORY INFECTIONS; PANCREATIC INSUFFICIENCY; maldigestion; salt depletion; and HEAT PROSTRATION.	0	2.17	1	0
Infections, Staphylococcal Skin [description not available]	0	11.28	13	6
Neutropenia A decrease in the number of NEUTROPHILS found in the blood.	0	7.52	2	0
Staphylococcal Skin Infections Infections to the skin caused by bacteria of the genus STAPHYLOCOCCUS.	0	11.28	13	6
Staphylococcal Pneumonia [description not available]	0	3.71	3	0
Pneumonia, Staphylococcal Pneumonia caused by infections with bacteria of the genus STAPHYLOCOCCUS, usually with STAPHYLOCOCCUS AUREUS.	0	3.71	3	0
Adverse Drug Event [description not available]	0	5.73	2	1
Drug-Related Side Effects and Adverse Reactions Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.	0	5.73	2	1
Erythema Redness of the skin produced by congestion of the capillaries. This condition may result from a variety of disease processes.	0	4.4	1	1
Chronic Kidney Failure [description not available]	0	7.52	4	4
Liver Dysfunction [description not available]	0	7.52	4	4
Kidney Failure, Chronic The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.	0	7.52	4	4
Liver Diseases Pathological processes of the LIVER.	1	9.52	4	4
Encephalopathy, Toxic [description not available]	0	2.11	1	0
Group A Strep Infection [description not available]	0	8.03	7	4
Streptococcal Infections Infections with bacteria of the genus STREPTOCOCCUS.	0	8.03	7	4
Infective Endocarditis [description not available]	0	2.11	1	0
Endocarditis Inflammation of the inner lining of the heart (ENDOCARDIUM), the continuous membrane lining the four chambers and HEART VALVES. It is often caused by microorganisms including bacteria, viruses, fungi, and rickettsiae. Left untreated, endocarditis can damage heart valves and become life-threatening.	0	7.11	1	0
Dermatoses [description not available]	0	2.11	1	0
Skin Diseases Diseases involving the DERMIS or EPIDERMIS.	1	4.11	1	0
Pulmonary Consumption [description not available]	0	2.13	1	0
Tuberculosis, Pulmonary MYCOBACTERIUM infections of the lung.	0	2.13	1	0
Arthritides, Bacterial [description not available]	0	3.04	1	0
Infections, Prosthesis-Related [description not available]	0	3.04	1	0
Pneumonia, Pneumococcal A febrile disease caused by STREPTOCOCCUS PNEUMONIAE.	0	2.5	2	0
Catheter-Associated Infections [description not available]	0	2.13	1	0
Ache [description not available]	0	9.74	9	9
Injuries Used with anatomic headings, animals, and sports for wounds and injuries. Excludes cell damage, for which pathology is used.	0	9.74	9	9
Pain An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.	0	9.74	9	9
Wounds and Injuries Damage inflicted on the body as the direct or indirect result of an external force, with or without disruption of structural continuity.	0	9.74	9	9
Foreign Bodies Inanimate objects that become enclosed in the body.	0	2.13	1	0
Health Care Associated Infection [description not available]	0	2.13	1	0
Cross Infection Any infection which a patient contracts in a health-care institution.	0	2.13	1	0
Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)	0	5.01	4	0
Central Nervous System Infection [description not available]	0	2.15	1	0
Kahler Disease [description not available]	0	2.15	1	0
Cerebral Nocardiosis [description not available]	0	2.76	3	0
Multiple Myeloma A malignancy of mature PLASMA CELLS engaging in monoclonal immunoglobulin production. It is characterized by hyperglobulinemia, excess Bence-Jones proteins (free monoclonal IMMUNOGLOBULIN LIGHT CHAINS) in the urine, skeletal destruction, bone pain, and fractures. Other features include ANEMIA; HYPERCALCEMIA; and RENAL INSUFFICIENCY.	0	2.15	1	0
Actinomycetoma [description not available]	0	2.44	2	0
Mycetoma A chronic progressive subcutaneous infection caused by species of fungi (eumycetoma), or actinomycetes (actinomycetoma). It is characterized by tumefaction, abscesses, and tumor-like granules representing microcolonies of pathogens, such as MADURELLA fungi and bacteria ACTINOMYCETES, with different grain colors.	0	2.44	2	0
Actinomyces Infections [description not available]	0	2.04	1	0

tedizolid phosphate

Description

Cross-References

Synonyms (60)

Research Excerpts

Overview

Effects

Treatment

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Bioavailability

Dosage Studied

Roles (3)

Drug Classes (6)

Bioassays (11)

Research

Studies (112)

Market Indicators

Research Demand Index: 41.99

Study Types

Clinical Trials (28)

Trial Overview

Trial Outcomes

Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set

Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set

Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set

Response Rate at End of Therapy

Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set

Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set

Investigator's Assessment of Clinical Response at the 48-72 Hour Visit

Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit

To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set

Change From Baseline in Patient-reported Pain, by Study Visit

Investigator's Assessment of Clinical Response at the Day 7 Visit

Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets

Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.

Early Clinical Response Rate

Microbiological Response at Test of Cure (TOC)

Microbiological Response at End of Treatment (EOT)

Clinical Response at Test of Cure (TOC)

Clinical Response at End of Treatment Visit (EOT)

Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI])

Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI])

Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population

Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (mITT) Population

Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiologically-Evaluable 2 (ME-2) Population

Number of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population

Number of Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population

Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population

Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population

Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiologically-Evaluable 1 (ME-1) Population

Number of Methicillin-Resistant Staphylococcus Aureus (MRSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population

Number of Methicillin-Susceptible Staphylococcus Aureus (MSSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population

Number of Participants Discontinuing Study Therapy Due to an Adverse Event (AE)

Number of Participants With ≥1 Adverse Events (AEs)

This Outcome Measure is the Maximum Plasma Concentration of Tedizolid in Morbidly Obese Subjects Compared to Nonobese Subjects

This Outcome Measure is the Tedizolid Area Under the Concentration Time-curve From Time 0 to 72 Hours in Morbidly Obese Subjects and Matched Non-obese Subjects.

Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity

Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Last Detectable Measurement

Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Infinity

Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Last Detectable Measurement

Clearance (CL) of Tedizolid (Active Metabolite) in Participants Who Received Tedizolid Phosphate Intravenously (IV)

Clearance (CL) of Tedizolid Phosphate (Prodrug) in Participants Who Received Tedizolid Phosphate Intravenously (IV)

Clearance (CL/F) of Tedizolid Phosphate in Participants Who Received Oral Tedizolid Phosphate (Prodrug)

Terminal Elimination Half-life (T1/2) of Tedizolid (Active Metabolite)

Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid Phosphate (Prodrug)

Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid (the Active Metabolite)

Clearance (CL/F) of Tedizolid (Active Metabolite) in Participants Who Received Oral Tedizolid Phosphate

Number of Participants Who Experienced at Least One Adverse Event

Number of Participants Who Discontinued Study Drug Due to an Adverse Event

Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid Phosphate (Prodrug)

Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid (the Active Metabolite)

Dose Normalized Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity

Terminal Elimination Half-life (T1/2) of Tedizolid Phosphate (Prodrug)

"Number of Participants With an Outcome of Cure as Defined as no Need for Further Antibiotics Beyond the Originally Planned Duration Determined by the Participant's Primary/Treating Physician."

Quantify the Safety of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated

Quantify the Tolerability of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated

Related Drugs (78)

Related Conditions (71)