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moxidectin

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Description

moxidectin: family of macrolide antibiotics with insecticidal & acaricidal activity [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID121595926
MeSH IDM0317480

Synonyms (1)

Synonym
moxidectin

Research Excerpts

Toxicity

Moxidectin was well tolerated across all treatment groups. No serious adverse events were recorded and all reported symptoms were classified as mild.

ExcerptReferenceRelevance
" Adverse clinical reactions were not observed in moxidectin- or vehicle-treated cows."( Safety assessment of moxidectin 1% injectable on reproductive performance in beef cows.
Larsen, RE; Rae, DO; Wang, GT, 1994
)
0.29
" Safety and tolerability were assessed by physical examinations, ongoing evaluation of adverse events (AEs), and measurement of laboratory values."( The antiparasitic moxidectin: safety, tolerability, and pharmacokinetics in humans.
Brown, KR; Chen, CY; Cotreau, MM; Fleckenstein, L; Rock, D; Ryan, JL; Schwertschlag, US; Vanapalli, SR; Warren, S, 2003
)
0.32
" Based on results of this study, the no observed adverse effect level for moxidectin sustained-release injectable (ProHeart 6) treatment in 10-week-old puppies was determined to be three times the recommended rate."( Safety evaluation of moxidectin sustained-release injectable in 10-week-old puppies.
Heaney, K; Lindahl, RG, 2005
)
0.33
" No adverse events attributable to treatment with the test articles were observed during the study."( Safety of imidacloprid plus moxidectin topical solution applied to cats heavily infected with adult heartworms (Dirofilaria immitis).
Arther, RG; Atkins, C; Ciszewski, DK; Davis, WL; Ensley, SM; Settje, TL, 2005
)
0.33
" Only three mild, possibly drug-related adverse reactions were observed among alI treated animals (two in the imidacloprid/moxidectin group, one in the selamectin group)."( Efficacy and safety of imidacloprid 10% plus moxidectin 2.5% spot-on in the treatment of sarcoptic mange and otoacariosis in dogs: results af a European field study.
Dumont, P; Heine, J; Hellmann, K; Krieger, K, 2005
)
0.33
" No serious adverse effects to treatment were recorded: most of the minor adverse effects were gastrointestinal such as diarrhea (nine dogs), vomitus (eight dogs) and salivation (three dogs)."( Efficacy and safety of imidacloprid/moxidectin spot-on solution and fenbendazole in the treatment of dogs naturally infected with Angiostrongylus vasorum (Baillet, 1866).
Heine, J; Jensen, AL; Koch, J; Kristensen, AT; Willesen, JL, 2007
)
0.34
" No treated animals showed adverse events."( Efficacy and safety of imidacloprid 10%/moxidectin 1% spot-on formulation in the treatment of feline aelurostrongylosis.
Di Cesare, A; Heine, J; Iorio, R; Lohr, B; Milillo, P; Pampurini, F; Paoletti, B; Schaper, R; Traversa, D, 2009
)
0.35
" The three dogs were tested for the presence of the multi-drug resistance 1 gene deletion, which can cause an increased sensitivity to the toxic effects of moxidectin, and were found to be negative."( Toxicity in three dogs from accidental oral administration of a topical endectocide containing moxidectin and imidacloprid.
McGill, SE; Raisis, AL; See, AM; Swindells, KL, 2009
)
0.35
" Advocate(®) spot-on for small cats and ferrets is an effective and safe treatment for ear mite infection in ferrets."( Efficacy and safety of the combination imidacloprid 10 % / moxidectin 1.0 % spot-on (Advocate(®) spot-on for small cats and ferrets) in the treatment of ear mite infection (Otodectes cynotis) in ferrets.
Bour, S; Le Sueur, C; Schaper, R, 2011
)
0.37
" Also, treated cats showed no adverse events."( Efficacy and safety of imidacloprid 10%/moxidectin 1% spot-on formulation in the treatment of feline infection by Capillaria aerophila.
Braun, G; Castagna, G; Di Cesare, A; Di Giulio, E; Lohr, B; Milillo, P; Pampurini, F; Schaper, R; Strube, K; Traversa, D, 2012
)
0.38
"3 µmol/kg for IVM and MOX, respectively, demonstrating that MOX was less toxic than IVM."( Relative neurotoxicity of ivermectin and moxidectin in Mdr1ab (-/-) mice and effects on mammalian GABA(A) channel activity.
Lespine, A; Ménez, C; Prichard, R; Sutra, JF, 2012
)
0.38
" This model can be used to identify toxic P-gp substrates with altered safety in dog populations and may reduce dog use in safety studies that are part of the drug approval process."( P-gp substrate-induced neurotoxicity in an Abcb1a knock-in/Abcb1b knock-out mouse model with a mutated canine ABCB1 targeted insertion.
Buckely, LE; Jhingory, MV; Jones, YL; Lancaster, VA; Myers, MJ; Orzechowski, KL; Robl, MG; Swaim, HL; Swain, MD; Tinaza, CA; Yancy, HF, 2013
)
0.39
" No adverse events related to treatment were reported during the study."( Safety and efficacy of 10% imidacloprid+2.5% moxidectin for the treatment of Dirofilaria immitis circulating microfilariae in experimentally infected dogs.
Arther, R; Davis, W; McCall, JW; Settje, T, 2014
)
0.4
" No serious adverse events associated with either product were observed during the study."( Clinical evaluation of the safety and efficacy of 10% imidacloprid + 2.5% moxidectin topical solution for the treatment of ear mite (Otodectes cynotis) infestations in dogs.
Arther, RG; Davis, WL; Jacobsen, JA; Lewis, VA; Settje, TL, 2015
)
0.42
" It is concluded that Seresto(®) is chemically compatible with solvents used in major spot-on formulations on the market and is dermally and systemically safe for adult dogs and cats when used concomitantly with Advocate(®) and Profender(®) spot-on formulations."( Chemical Compatibility and Safety of Imidacloprid/Flumethrin Collar (Seresto®) Concomitantly Used with Imidacloprid/Moxidectin (Advocate®, Advantage® Multi) and Emodepside/Praziquantel (Profender®) Spot-on Formulations.
Crafford, D; Deuster, K; Fourie, J; Krüdewagen, EM; Remer, C; Schunack, B; Stanneck, D; Wolken, S, 2015
)
0.42
"No adverse events related to the two products, nor skin reactions, general signs, or changes in the haematological profile, were observed during the study."( Six-month field efficacy and safety of the combined treatment of dogs with Frontline Tri-Act® and NexGard Spectra®.
Abbate, JM; Arfuso, F; Beugnet, F; Brianti, E; Gaglio, G; Giannetto, S; Halos, L; Napoli, E, 2018
)
0.48
"Concurrent topical administration of a fluralaner plus moxidectin and a praziquantel product did not result in adverse findings."( Safety of topical administration of fluralaner plus moxidectin concurrently with praziquantel in cats.
Fisara, P; Roepke, RKA; Walther, FM, 2018
)
0.48
" Both products were safe and well tolerated."( Field effectiveness and safety of fluralaner plus moxidectin (Bravecto® Plus) against ticks and fleas: a European randomized, blinded, multicenter field study in naturally-infested client-owned cats.
Gil, MJ; Loehlein, W; Pobel, T; Roepke, RKA; Rohdich, N; Wolf, O; Zschiesche, E, 2018
)
0.48
" Study 4: PH 12 produced marked reductions in circulating microfilariae and lower numbers of adult heartworms, but no adverse clinical signs were identified."( Safety of an extended-release injectable moxidectin suspension formulation (ProHeart
Alleman, K; Boucher, JF; Carroll, R; Collard, W; Esch, K; Fielder, A; Krautmann, MJ; Kryda, K; Luo, L; Mahabir, S; McCandless, E; Morton, T; Nederveld, S; Wolthuis, TL, 2019
)
0.51
"Simparica Trio™ administered orally once monthly for two consecutive treatments was safe and effective against natural flea infestations and substantially improved clinical signs associated with FAD in client-owned dogs in a field study conducted in the USA."( Safety and efficacy of a novel oral chewable combination tablet containing sarolaner, moxidectin and pyrantel (Simparica Trio™) against natural flea infestations in client-owned dogs in the USA.
Inskeep, T; Kryda, K; Mahabir, SP; Rugg, J, 2020
)
0.56
" Moxidectin was well tolerated across all treatment groups, with no serious adverse events being recorded and all reported symptoms being classified as mild."( Efficacy and safety of ascending doses of moxidectin against Strongyloides stercoralis infections in adults: a randomised, parallel-group, single-blinded, placebo-controlled, dose-ranging, phase 2a trial.
Chongvilay, B; Hattendorf, J; Hofmann, D; Keiser, J; Sayasone, S; Sengngam, K, 2021
)
0.62
" No serious adverse events were reported during the study."( Efficacy and safety of moxidectin and albendazole compared with ivermectin and albendazole coadministration in adolescents infected with Trichuris trichiura in Tanzania: an open-label, non-inferiority, randomised, controlled, phase 2/3 trial.
Ali, SM; Hattendorf, J; Hürlimann, E; Keiser, J; Mrimi, EC; Welsche, S, 2023
)
0.91
" Most common adverse events were abdominal pain (range across arms: 11."( Efficacy and Safety of Moxidectin-Albendazole and Ivermectin-Albendazole Combination Therapy Compared to Albendazole Monotherapy in Adolescents and Adults Infected with Trichuris trichiura: A Randomized, Controlled Superiority Trial.
Coulibaly, JT; Hattendorf, J; Hürlimann, E; Keiser, J; Sprecher, VP, 2023
)
0.91
"One hundred sixty-four individuals were treated, and monitored for treatment emergent adverse events (TEAE)."( Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d'Ivoire: A randomized controlled superiority study.
Bjerum, CM; Budge, PJ; Fischer, PU; Gabo, PT; Goss, CW; King, CL; Koudou, BG; Lew, D; Ouattara, AF; Weil, GJ, 2023
)
0.91

Pharmacokinetics

Moxidectin is a potent antiparasitic drug of the macrocyclic lactone (ML) family. We found no relationship between severity of infection (mild, moderate or severe) and exposure parameters (AUC0-∞ and Cmax), T1/2 and Tmax for moxidector.

ExcerptReferenceRelevance
" It is concluded that in horses the commercial preparation of MXD presents a pharmacokinetic profile which differs significantly from that found for a commercial preparation of IVM."( Comparison of the pharmacokinetics of moxidectin (Equest) and ivermectin (Eqvalan) in horses.
Alvinerie, M; Cabezas, I; Galtier, P; García, M; Pérez, R; Rubilar, L; Sutra, JF, 1999
)
0.3
" The method is suitable for pharmacokinetic studies of moxidectin after oral administration to humans."( Liquid chromatographic assay of moxidectin in human plasma for application to pharmacokinetic studies.
Chen, YC; Fleckenstein, L; Hung, YP, 2002
)
0.31
"To study the pharmacokinetics and dose proportionality of moxidectin in beagle dogs experimentally infected with the filarial parasite Brugia pahangi, and to evaluate and compare the results obtained from population pharmacokinetic analysis and individual compartmental analysis."( Pharmacokinetics and dose proportionality of oral moxidectin in beagle dogs.
Dzimianski, MT; Fleckenstein, L; Hung, YP; McCall, JW; Vanapalli, SR, 2002
)
0.31
"The best pharmacokinetic model was a two-compartment model with first-order absorption."( Pharmacokinetics and dose proportionality of oral moxidectin in beagle dogs.
Dzimianski, MT; Fleckenstein, L; Hung, YP; McCall, JW; Vanapalli, SR, 2002
)
0.31
" Reducing the rate of fat deposition influenced the pharmacokinetic disposition of the highly lipophilic MXD but did not influence the pharmacokinetic disposition of the less lipophilic IVM."( Does the rate of fat deposition influence the pharmacokinetic disposition of subcutaneously administered moxidectin and ivermectin in pigs?
Craven, J; Friis, C; Hennessy, DR, 2002
)
0.31
" Pharmacokinetic (PK) samples were collected just prior to dosing and at various time points until 80 days postdose."( The antiparasitic moxidectin: safety, tolerability, and pharmacokinetics in humans.
Brown, KR; Chen, CY; Cotreau, MM; Fleckenstein, L; Rock, D; Ryan, JL; Schwertschlag, US; Vanapalli, SR; Warren, S, 2003
)
0.32
" The aim of the current work was to evaluate the effect of verapamil, a P-GP substrate, on the pharmacokinetic behaviour of the anthelmintics ivermectin and moxidectin in sheep."( Influence of verapamil on the pharmacokinetics of the antiparasitic drugs ivermectin and moxidectin in sheep.
Lanusse, C; Lifschitz, A; Molento, MB; Prichard, R; Sallovitz, J, 2004
)
0.32
"Most pharmacokinetic studies on anthelmintic drugs have been performed on non-parasitized animals."( The influence of parasitism on the pharmacokinetics of moxidectin in lambs.
Alvinerie, M; Aumont, G; Dupuy, J; Lespine, A; Sutra, JF, 2004
)
0.32
"We studied the influence of dyslipemia on the distribution of moxidectin, a potent antiparasitic drug of the macrocyclic lactone (ML) family, in plasma lipoproteins and on its pharmacokinetic behaviour."( Influence of dyslipidemia on moxidectin distribution in plasma lipoproteins and on its pharmacokinetics.
Alvinerie, M; Bassissi, MF; Lespine, A; Martin, PG; Perret, B, 2006
)
0.33
" Moxidectin and lipids were measured in plasma and in lipoproteins and the pharmacokinetic parameters calculated."( Influence of dyslipidemia on moxidectin distribution in plasma lipoproteins and on its pharmacokinetics.
Alvinerie, M; Bassissi, MF; Lespine, A; Martin, PG; Perret, B, 2006
)
0.33
" The obtained data were analysed by compartmental and non-compartmental pharmacokinetic techniques."( Comparison of the pharmacokinetics of moxidectin and ivermectin after oral administration to beagle dogs.
Al-Azzam, SI; Cheng, KJ; Dzimianski, MT; Fleckenstein, L; McCall, JW, 2007
)
0.34
" Our primary aim was to determine the pharmacokinetic parameters of a macrocyclic lactone, moxidectin, to assist in the development of effective treatment protocols."( Pharmacokinetics of moxidectin in the southern hairy-nosed wombat (Lasiorhinus latifrons).
Death, CE; Holyoake, C; Milne, R; Schultz, DJ; Taggart, DA; Warren, KS; Williams, DB, 2011
)
0.37
" Half-life was longer (p=0."( Pharmacokinetics of moxidectin in alpacas following administration of an oral or subcutaneous formulation.
Cocquyt, CM; Cox, S; Martín-Jiménez, T; Rohrbach, B; Van Amstel, S, 2016
)
0.43
" Plasma and skin pharmacokinetic profiles were determined."( Preclinical Study of Single-Dose Moxidectin, a New Oral Treatment for Scabies: Efficacy, Safety, and Pharmacokinetics Compared to Two-Dose Ivermectin in a Porcine Model.
Aho, LS; Bernigaud, C; Botterel, F; Chosidow, O; Dreau, D; Fang, F; Fischer, K; Guillot, J; Kelly, A; Lespine, A; Lilin, T; Moreau, F; Sutra, JF, 2016
)
0.43
" Pharmacokinetic (PK) and -dynamic studies are required to support its clinical development."( Development and validation of an LC-MS/MS method for the quantification of the anthelmintic drug moxidectin in a volumetric absorptive microsample, blood, and plasma: Application to a pharmacokinetic study of adults infected with Strongyloides stercoralis
Hofmann, D; Keiser, J; Sayasone, S, 2021
)
0.62
" Pharmacokinetic samples were collected prior to dosing and at intervals up to 12 months post-dose from 33 and 34 individuals treated with 2 and 4 mg moxidectin, respectively and up to 18 months post-dose from 31 individuals treated with 8 mg moxidectin."( Pharmacokinetics of oral moxidectin in individuals with Onchocerca volvulus infection.
Attah, SK; Awadzi, K; Fleckenstein, L; Kuesel, AC; Lazdins-Helds, J; Opoku, N; Rayner, C; Ryg-Cornejo, V; Sullivan, M; Tan, B, 2022
)
0.72
"We found no relationship between severity of infection (mild, moderate or severe) and exposure parameters (AUC0-∞ and Cmax), T1/2 and Tmax for moxidectin."( Pharmacokinetics of oral moxidectin in individuals with Onchocerca volvulus infection.
Attah, SK; Awadzi, K; Fleckenstein, L; Kuesel, AC; Lazdins-Helds, J; Opoku, N; Rayner, C; Ryg-Cornejo, V; Sullivan, M; Tan, B, 2022
)
0.72
" Pharmacokinetic parameters were determined using standard non-compartmental analysis methods."( Pharmacokinetics of Moxidectin combined with Albendazole or Albendazole plus Diethylcarbamazine for Bancroftian Filariasis.
Alshehri, A; Bala, V; Bjerum, C; Budge, PJ; Chhonker, YS; Fischer, PU; Gabo, TP; King, CL; Koudou, BG; Meïté, A; Murry, DJ; Ouattara, AF; Weil, GJ, 2023
)
0.91

Compound-Compound Interactions

The strategic use of moxidectin or closantel in combination with levamisole (LEV) to control gastrointestinal nematodes of sheep in the highlands of central Kenya was examined.

ExcerptReferenceRelevance
"The strategic use of moxidectin or closantel in combination with levamisole (LEV) to control gastrointestinal nematodes of sheep in the highlands of central Kenya was examined."( Strategic use of moxidectin or closantel in combination with levamisole in the control of nematodes of sheep in the highlands of central Kenya.
Gichigi, MN; Maingi, N; Munyua, WK, 2002
)
0.31
" In female worms, Dim-pgp-10, Dim-haf-1 and Dim-haf-5 were upregulated compared to controls with doxycycline alone and when combined with ivermectin."( Transporter gene expression and Wolbachia quantification in adults of Dirofilaria immitis treated in vitro with ivermectin or moxidectin alone or in combination with doxycycline for 12 h.
Bazzocchi, C; Cafiso, A; Ciuca, L; Genchi, M; Kramer, LH; Lucchetti, C; McCall, J; Vismarra, A, 2022
)
0.72

Bioavailability

The systemic bioavailability of oral moxidectin coadministered with lipid was only 40% in the lymph duct-cannulated dogs compared with 71% in controls. The apparent absorption rate of moxIDectin was not significantly different after oral and subcutaneous administration but the extent of absorption, reflected in the peak concentration (C(max) and the area under the concentration-time curve (AUC), was increased.

ExcerptReferenceRelevance
" The AUC were similar after both treatments indicating the same bioavailability for the two routes of administration."( The pharmacokinetics of moxidectin after oral and subcutaneous administration to sheep.
Alvinerie, M; Eeckhoutte, C; Escudero, E; Galtier, P; Sutra, JF,
)
0.13
" The apparent absorption rate of moxidectin was not significantly different after oral and subcutaneous administration but the extent of absorption, reflected in the peak concentration (C(max)) and the area under the concentration-time curve (AUC), of the subcutaneous injection (24."( Pharmacokinetics of moxidectin and doramectin in goats.
Alvinerie, M; Carceles, CM; Diaz, MS; Escudero, E; Galtier, P; Sutra, JF, 1999
)
0.3
" This in vitro study allowed selection of compounds which are able to increase the moxidectin bioavailability in lambs."( Enhancement of moxidectin bioavailability in lamb by a natural flavonoid: quercetin.
Alvinerie, M; Dupuy, J; Larrieu, G; Lespine, A; Sutra, JF, 2003
)
0.32
" Lipid-based formulations should improve the bioavailability of moxidectin in rabbits."( Enhancement of oral moxidectin bioavailability in rabbits by lipid co-administration.
Alvinerie, M; Bassissi, MF; Lespine, A, 2004
)
0.32
" Oral bioavailability after drug ingestion due to allo-licking was 13."( Endectocide exchanges between grazing cattle after pour-on administration of doramectin, ivermectin and moxidectin.
Alvinerie, M; Bousquet-Mélou, A; Mercadier, S; Toutain, PL, 2004
)
0.32
" The systemic bioavailability of oral moxidectin coadministered with lipid was only 40% in the lymph duct-cannulated dogs compared with 71% in the controls."( Contribution of lymphatic transport to the systemic exposure of orally administered moxidectin in conscious lymph duct-cannulated dogs.
Alvinerie, M; Bassissi, FM; Bousquet-Melou, A; Chanoit, G; Lallemand, E; Lespine, A; Toutain, PL, 2006
)
0.33
"Moxidectin is a long-acting anthelmintic drug for which little is known about its kinetic behaviour in dogs and its oral absolute bioavailability has never been reported."( Estimation of absolute oral bioavailability of moxidectin in dogs using a semi-simultaneous method: influence of lipid co-administration.
Alvinerie, M; Bousquet-Melou, A; Lallemand, E; Lespine, A; Toutain, PL, 2007
)
0.34
" The changes are consistent with an increase in moxidectin bioavailability following administration with food."( The effect of a high-fat breakfast on the pharmacokinetics of moxidectin in healthy male subjects: a randomized phase I trial.
Cailleux, K; Chalon, S; Fitoussi, S; Fleckenstein, L; Gourley, I; Korth-Bradley, JM; Matschke, K; Parks, V, 2012
)
0.38
" The relative bioavailability of the oral moxidectin to the subcutaneous moxidectin was 11%."( Pharmacokinetics of moxidectin in alpacas following administration of an oral or subcutaneous formulation.
Cocquyt, CM; Cox, S; Martín-Jiménez, T; Rohrbach, B; Van Amstel, S, 2016
)
0.43

Dosage Studied

Beagle dogs were operated for lymph duct cannulation and were orally dosed with 38g of corn oil and moxidectin. All Sarcoptes-infested dogs were topically treated twice (days 0 and 28) with the dosage recommended by the respective manufacturer.

ExcerptRelevanceReference
" Groups 1 and 3 were given milbemycin oxime at a dosage of 500 micrograms/kg of body weight, PO, on day 0 and on days 0 and 30, respectively; groups 2 and 4 were nontreated controls."( Efficacy of milbemycin oxime against experimentally induced Ancylostoma caninum and Uncinaria stenocephala infections in dogs.
Bhopale, V; Niamatali, S; Schad, GA, 1992
)
0.28
"Fifteen Collies, previously having mild reactions to ivermectin challenge (120 micrograms/kg of body weight; 20 times the recommended dosage level), were studied to evaluate the effects of milbemycin oxime administration at 5 and 10 mg/kg (10 and 20 times the manufacturer's recommended dosage)."( Assessment of toxicosis induced by high-dose administration of milbemycin oxime in collies.
Paul, AJ; Todd, KS; Tranquilli, WJ, 1991
)
0.28
" More appropriately, drug resistance should be defined as 'a change in gene frequency of a population, produced by drug selection, which renders the minimal, effective dosage previously used to kill a defined portion (e."( Structure and activity of avermectins and milbemycins in animal health.
Fisher, MH; Mrozik, H; Shoop, WL, 1995
)
0.29
"The concentration of moxidectin, a macrocyclic lactone endectocide, in the blood serum of cattle resulting from single and daily subcutaneous injections and oral dosing was determined as a function of time."( Moxidectin: pharmacokinetics and activity against horn flies (Diptera: Muscidae) and trichostrongyle nematode egg production.
Miller, JA; Oehler, DD; Scholl, PJ, 1994
)
0.29
" The dosage of ivermectin required to remove 95 per cent of the ivermectin-resistant O circumcincta and T colubriformis were 23 times and six times larger, respectively, than the dosages required to remove the same percentage of susceptible isolates."( Mutual resistance to avermectins and milbemycins: oral activity of ivermectin and moxidectin against ivermectin-resistant and susceptible nematodes.
Eary, CH; Haines, HW; Michael, BF; Shoop, WL, 1993
)
0.29
" Moxidectin demonstrated a trend towards greater efficacy against encysted cyathostome larvae than a therapeutic dosage of ivermectin, but this difference was not statistically significant."( Comparison of moxidectin oral gel and ivermectin oral paste against a spectrum of internal parasites of ponies with special attention to encysted cyathostome larvae.
Chapman, MR; French, DD; Klei, TR; Monahan, CM; Taylor, HW, 1996
)
0.29
" The ewes in each group were dosed with their anthelmintic on April 4 (day 0) before being turned out to separate equal-sized paddocks within the same field on the following morning."( Efficacy of moxidectin, ivermectin and albendazole oral drenches for suppression of periparturient rise in ewe worm egg output and reduction of anthelmintic treatment for lambs.
Edgar, HW; Ellison, S; Ferguson, L; Kenny, J; Taylor, SM, 1997
)
0.3
" In a third study, two prophylactic dosing schemes involving three ivermectin treatments at intervals of eight weeks, and two moxidectin treatments 12 weeks apart, were found to be highly effective in controlling strongyle infections of horses on pasture."( Comparative studies of ivermectin and moxidectin in the control of naturally acquired cyathostome infections in horses.
Claerebout, E; Demeulenaere, D; Dorny, P; Vercruysse, J, 1997
)
0.3
"In a trial designed to evaluate the efficacy of the recommended dosage of moxidectin 2% oral gel against the gastric stages of Gasterophilus spp."( Efficacy of moxidectin 2% oral gel against second- and third-instar Gasterophilus intestinalis De Geer.
Chapman, MR; French, DD; Klei, TR; Scholl, PJ, 1998
)
0.3
" The anthelmintic efficacy of the solid formulation was assessed at four dosage levels in sheep and it was demonstrated that the dosage of anthelmintic agent could be reduced to 1/6 of the present recommended injectable dose."( Sustained-release delivery systems and their application for endoparasite control in animals.
Birks, DV; Brandon, MR; Cardamone, M; Lee, RP; Lofthouse, SA; Lucas, JC; O'Donoghue, M, 1998
)
0.3
"Persistent anthelmintic efficacy of topical formulations (all at a dosage of 500 microg/kg) of doramectin (DOR), ivermectin (IVM), eprinomectin (EPR) and moxidectin (MOX), in comparison with untreated control cattle (CONT), was observed in stocker beef calves during a 112-day winter-spring grazing trial."( A comparison of persistent anthelmintic efficacy of topical formulations of doramectin, ivermectin, eprinomectin and moxidectin against naturally acquired nematode infections of beef calves.
Clymer, BC; DeRosa, A; Guerino, F; Gurie, J; Loyacano, AF; Williams, JC, 1999
)
0.3
"5% pour-on at a dosage of 500 microg of moxidectin/kg body weight and heifers from the other group remained as untreated controls."( Moxidectin pour-on for control of natural populations of the cattle tick Boophilus microplus (Acarina: Ixodidae).
Anziani, OS; García Posse, F; Guglielmone, AA; Ioppolo, M; Mangold, AJ; Muñoz Cobeñas, ME; Scherling, N, 2000
)
0.31
"Eighty-eight lambs were allocated to one of four groups which were then dosed with 10,000 infective-stage larvae (L3) of one of four populations of Ostertagia circumcincta; the first (S) was an isolate known to be anthelmintic-susceptible; the second (OR) was a multiple anthelmintic-resistant isolate which had been recovered from the field following therapeutic failure of both ivermectin and moxidectin and subsequently maintained in the laboratory without further anthelmintic selection."( Resistance to therapeutic treatment with macrocyclic lactone anthelmintics in Ostertagia circumcincta.
Bisset, SA; Leathwick, DM; Moen, IC; Sutherland, IA, 2002
)
0.31
" Eight calves (Group 3) were also treated with moxidectin pour-on at the same dosage on Day 23 in order to determine efficacy against adult nematodes; eight control calves (Group 4) were matched with these principals."( Dose confirmation of moxidectin 0.5% pour-on against adults and fourth-stage larvae of various Cooperia spp. and Trichostrongylus colubriformis in Louisiana.
DeRosa, A; Williams, JC, 2003
)
0.32
"2 mg/kg, the dosage registered for other host species."( Anthelmintic treatment in horses: the extra-label use of products and the danger of under-dosing.
Matthee, S, 2003
)
0.32
" Pharmacokinetic (PK) samples were collected just prior to dosing and at various time points until 80 days postdose."( The antiparasitic moxidectin: safety, tolerability, and pharmacokinetics in humans.
Brown, KR; Chen, CY; Cotreau, MM; Fleckenstein, L; Rock, D; Ryan, JL; Schwertschlag, US; Vanapalli, SR; Warren, S, 2003
)
0.32
" Ewes were dosed after lambing with the aim of controlling their periparturient rise in faecal egg output and lambs were dosed at six-week intervals throughout the summer."( Failure of moxidectin to control benzimidazole-, levamisole- and ivermectin-resistant Teladorsagia circumcinda in a sheep flock.
Bartley, DJ; Jackson, F; Moir, AC; Sargison, ND, 2005
)
0.33
" Beagle dogs were operated for lymph duct cannulation and were orally dosed with 38g of corn oil and moxidectin (0."( Contribution of lymphatic transport to the systemic exposure of orally administered moxidectin in conscious lymph duct-cannulated dogs.
Alvinerie, M; Bassissi, FM; Bousquet-Melou, A; Chanoit, G; Lallemand, E; Lespine, A; Toutain, PL, 2006
)
0.33
" Unit-dose applicators and the dosing schedule used in these studies were designed to provide a minimum of 10mg imidacloprid and 1mg moxidectin/kg."( Imidacloprid/moxidectin topical solution for the prevention of heartworm disease and the treatment and control of flea and intestinal nematodes of cats.
Arther, RG; Charles, S; Ciszewski, DK; Davis, WL; Settje, TS, 2005
)
0.33
" All Sarcoptes-infested dogs were topically treated twice (days 0 and 28) with the dosage recommended by the respective manufacturer (27 dogs with imidacloprid/moxidectin, 26 with selamectin)."( Efficacy and safety of imidacloprid 10% plus moxidectin 2.5% spot-on in the treatment of sarcoptic mange and otoacariosis in dogs: results af a European field study.
Dumont, P; Heine, J; Hellmann, K; Krieger, K, 2005
)
0.33
" Ten Beagle dogs were dosed orally and then intravenously (i."( Estimation of absolute oral bioavailability of moxidectin in dogs using a semi-simultaneous method: influence of lipid co-administration.
Alvinerie, M; Bousquet-Melou, A; Lallemand, E; Lespine, A; Toutain, PL, 2007
)
0.34
" Animals received moxidectin (1% Cydectin, FortDodge) at an oral dosage of approximately 2 mg/kg body weight by micropipette; administration was repeated after 15 days."( Oral administration of moxidectin for treatment of murine acariosis due to Radfordia affinis.
Farca, AM; Peano, A; Pollicino, P; Rambozzi, L; Rossi, L, 2008
)
0.35
"The optimal dosage level of the combination for hedgehogs was determined by assigning 20 hedgehogs into three treatment groups (0."( Efficacy of a combination of 10% imidacloprid and 1% moxidectin against Caparinia tripilis in African pygmy hedgehog (Atelerix albiventris).
Ahn, KS; Kim, KR; Oh, DS; Shin, SS, 2012
)
0.38
" The dosage for all treatments was the licensed dose of 10–25 mg imidacloprid/2."( The efficacy of a topically applied imidacloprid 10 % / moxidectin 2.5 % formulation (Advocate®, Advantage® Multi, Bayer) against Immature and Adult Spirocerca lupi worms in experimentally infected dogs.
Austin, CM; Crafford, D; Kok, DJ; Schaper, R, 2013
)
0.39
" This blinded, randomized three-phase clinical trial compared its efficacy employing different dosing regimens with that of ivermectin."( Canine generalized demodicosis treated with varying doses of a 2.5% moxidectin+10% imidacloprid spot-on and oral ivermectin: parasiticidal effects and long-term treatment outcomes.
Ball, G; Fields, PJ; Halliwell, RE; Louw, J; Louw, ML; Paterson, TE; Pinckney, R, 2014
)
0.4
" When dogs receive consecutive doses of Advantage Multi for Dogs as prescribed, heartworm infections will be prevented throughout the monthly dosing interval after administration of several monthly doses."( Protection of dogs against canine heartworm infection 28 days after four monthly treatments with Advantage Multi® for Dogs.
Basel, C; Bowman, DD; Grazette, AR; Hostetler, JA; Wang, Y, 2016
)
0.43
" Commencing 4 weeks after birth all lambs were dosed weekly with 250 infective larvae (L3) of either an ML-susceptible or -resistant isolate of Teladorsagia circumcinta."( Selection for anthelmintic resistant Teladorsagia circumcincta in pre-weaned lambs by treating their dams with long-acting moxidectin injection.
Fraser, K; Leathwick, DM; Miller, CM, 2015
)
0.42
" The treatment regimen of monthly IMD + MOX topically (per labeled dosage and administration) for 10 months and 10 mg/kg doxycycline BID orally for 30 days was initiated 30 days post-surgical transplant."( Assessment of parasitological findings in heartworm-infected beagles treated with Advantage Multi® for dogs (10% imidacloprid + 2.5% moxidectin) and doxycycline.
Dzimianski, MT; Hostetler, JA; Moorhead, AR; Ohmes, CM; Savadelis, MD; Settje, TL; Zolynas, R, 2017
)
0.46
" Using the Worminator, we compared the dose-response characteristics of several avermectin/milbemycin (AM) compounds using L3 from both AM-susceptible and AM-resistant Cooperia spp."( Motility in the L3 stage is a poor phenotype for detecting and measuring resistance to avermectin/milbemycin drugs in gastrointestinal nematodes of livestock.
George, MM; Howell, SB; Kaplan, RM; Lopez-Soberal, L; Storey, BE, 2018
)
0.48
" Additionally, in the field study no dog tested positive for adult heartworm infection when dosed with the combination product monthly for 11 months, while two dogs treated with Heartgard® Plus tested positive."( Laboratory and field studies to investigate the efficacy of a novel, orally administered combination product containing moxidectin, sarolaner and pyrantel for the prevention of heartworm disease (Dirofilaria immitis) in dogs.
Chapin, S; Cundiff, B; Holzmer, SJ; Inskeep, T; Kryda, K; Maeder, SJ; Mahabir, SP; McCall, JW; McTier, TL; Myers, M; Pullins, A; Rugg, J; Six, RH; Ulrich, M; Walsh, KF, 2019
)
0.51
" Six laboratory studies were conducted to support dosage selection and efficacy confirmation of a novel combination of sarolaner, moxidectin and pyrantel against four tick species that commonly infest dogs in Europe."( Efficacy of a novel chewable tablet containing sarolaner, moxidectin and pyrantel (Simparica Trio™) against four common tick species infesting dogs in Europe.
Becskei, C; Liebenberg, J; Mahabir, SP; Thys, M, 2020
)
0.56
"2 mg/kg sarolaner was the lowest dosage evaluated that provided > 90% efficacy for at least 28 days and therefore was selected as the dosage to provide tick control for at least one month following a single oral treatment."( Efficacy of a novel chewable tablet containing sarolaner, moxidectin and pyrantel (Simparica Trio™) against four common tick species infesting dogs in Europe.
Becskei, C; Liebenberg, J; Mahabir, SP; Thys, M, 2020
)
0.56
" The initial study (Study 1) determined the efficacious dosage of moxidectin in the combination product by evaluating three different dose levels, and two follow-up studies (Studies 2 and 3) confirmed the efficacy of the selected moxidectin dose."( Efficacy of orally administered combination of moxidectin, sarolaner and pyrantel (Simparica Trio™) for the prevention of experimental Angiostrongylus vasorum infection in dogs.
Becskei, C; Doherty, P; Mahabir, SP; Thys, M, 2020
)
0.56
" Timing of dosing relative to infection allowed for efficacy to be evaluated against the immature adult (L5) stage."( Efficacy of orally administered combination of moxidectin, sarolaner and pyrantel (Simparica Trio™) for the prevention of experimental Angiostrongylus vasorum infection in dogs.
Becskei, C; Doherty, P; Mahabir, SP; Thys, M, 2020
)
0.56
" Twenty-two dogs with HWI whose owners declined melarsomine were treated with M/I at the preventive dosage twice monthly for 90 days then monthly thereafter and doxycycline (median [interquartile range; IQR] dosage 12."( Non-Arsenical heartworm adulticidal therapy using topical moxidectin-imidacloprid and doxycycline: A prospective case series.
Ames, MK; Atkins, CE; Evans, C; VanVranken, P, 2020
)
0.56
" stercoralis-infected adults using a pharmacometric approach, and to perform model-based simulations to explore different drug dosing strategies."( Characterization of the Population Pharmacokinetics of Moxidectin in Adults Infected with Strongyloides Stercoralis: Support for a Fixed-Dose Treatment Regimen.
Hofmann, D; Keiser, J; Pfister, M; Sayasone, S; Smit, C, 2022
)
0.72
" Equivalent exposures after fixed-dose and weight-dependent dosing strategies support the use of a simple fixed-dose approach, particularly in large-scale treatment programs."( Characterization of the Population Pharmacokinetics of Moxidectin in Adults Infected with Strongyloides Stercoralis: Support for a Fixed-Dose Treatment Regimen.
Hofmann, D; Keiser, J; Pfister, M; Sayasone, S; Smit, C, 2022
)
0.72
" Population-based pharmacometric modeling that would help to identify an ideal dosing strategy are yet lacking."( Optimizing moxidectin dosing for Strongyloides stercoralis infections: Insights from pharmacometric modeling.
Hofmann, D; Keiser, J; Pfister, M; Sayasone, S; Smit, C, 2022
)
0.72
" As no new products are available utilizing a novel drug class for the prevention of this disease, the only options for combating ML resistance include increasing the dose and/or changing the dosage regime of current MLs, or by optimizing the formulations of MLs currently available."( Moxidectin: heartworm disease prevention in dogs in the face of emerging macrocyclic lactone resistance.
Kryda, K; Maeder, SJ; McTier, TL; Savadelis, MD; Woods, DJ, 2022
)
0.72
" Pharmacokinetic samples were collected prior to dosing and at intervals up to 12 months post-dose from 33 and 34 individuals treated with 2 and 4 mg moxidectin, respectively and up to 18 months post-dose from 31 individuals treated with 8 mg moxidectin."( Pharmacokinetics of oral moxidectin in individuals with Onchocerca volvulus infection.
Attah, SK; Awadzi, K; Fleckenstein, L; Kuesel, AC; Lazdins-Helds, J; Opoku, N; Rayner, C; Ryg-Cornejo, V; Sullivan, M; Tan, B, 2022
)
0.72
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (866)

TimeframeStudies, This Drug (%)All Drugs %
pre-199026 (3.00)18.7374
1990's197 (22.75)18.2507
2000's251 (28.98)29.6817
2010's275 (31.76)24.3611
2020's117 (13.51)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials200 (22.65%)5.53%
Reviews44 (4.98%)6.00%
Case Studies47 (5.32%)4.05%
Observational1 (0.11%)0.25%
Other591 (66.93%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (20)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase II, Randomized, Double-blind, Parallel Group Dose Finding Study of Single Oral Doses of Moxidectin in Adults With Scabies [NCT03905265]Phase 222 participants (Actual)Interventional2020-01-13Completed
A Randomized, Double Blind, Parallel Trial in the Democratic Republic of Congo (DRC) Comparing the Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Treatment of Onchocerciasis [NCT03876262]Phase 3323 participants (Actual)Interventional2021-05-03Active, not recruiting
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Potential Effect of a Single Oral Dose of Moxidectin on the Cardiac QT Interval of Healthy Volunteers [NCT03012828]Phase 160 participants (Actual)Interventional2017-01-31Completed
Efficacy and Safety of Moxidectin and Albendazole Compared to Ivermectin and Albendazole Co-administration in Adolescents Infected With Trichuris Trichiura: a Randomized Controlled Trial [NCT04700423]Phase 2/Phase 3536 participants (Actual)Interventional2021-03-01Completed
Efficacy, Safety and Pharmacokinetics of Ascending Dosages of Moxidectin Alone and in Comparison to Ivermectin Against Strongyloides Stercoralis in Adults: a Randomized Controlled Trial [NCT04056325]Phase 2210 participants (Anticipated)Interventional2019-11-27Enrolling by invitation
An Open-Label, Randomized, Single-Dose, Parallel-Group Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Moxidectin Administered Orally to Healthy Subjects [NCT00736697]Phase 154 participants (Actual)Interventional2008-11-30Completed
A Phase 2, Placebo-controlled, Double-blind, Randomized, Dose Ranging, Efficacy and Safety Study of Orally Administered Moxidectin in Adults With Scabies. [NCT05875441]Phase 2200 participants (Anticipated)Interventional2023-11-23Recruiting
A Single-Center, Open-Label, Single-Dose Study To Assess The Pharmacokinetics, Safety, And Tolerability Of Moxidectin In Subjects Aged 4 To 11 Years ( >=12 kg) With Or Without Onchocerca Volvulus Infection [NCT01035619]Phase 20 participants (Actual)Interventional2011-04-30Withdrawn
An Open-Label, Single-Dose Study to Evaluate the Excretion of Moxidectin Into the Breast Milk of Lactating, Non-breastfeeding Women. [NCT00751764]Phase 112 participants (Anticipated)Interventional2008-11-30Completed
A Clinical Trial to Assess the Safety and Efficacy of Moxidectin Combination Treatments vs. Ivermectin Combination Treatments for Bancroftian Filariasis [NCT04410406]Phase 3164 participants (Actual)Interventional2020-08-20Active, not recruiting
A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus [NCT00790998]Phase 31,497 participants (Actual)Interventional2009-04-30Completed
An Open-label, Single-Dose, 4-Period, Sequential Study to Determine the Effect of Moxidectin on CYP3A4 Activity in Healthy Subjects Using Midazolam as a Probe Substrate [NCT00856362]Phase 138 participants (Anticipated)Interventional2009-04-30Completed
Randomized Clinical Trial, Double-blind, Single-dose Drug and Escalating Infection Intensities, Evaluating the Safety and Efficacy of Moxidectin 2 mg, Ivermectin-controlled, in Loa Loa Microfilaremic Patients [NCT04049851]Phase 272 participants (Actual)Interventional2022-04-07Active, not recruiting
Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis [NCT06070116]Phase 2300 participants (Anticipated)Interventional2024-01-15Not yet recruiting
Efficacy and Safety of Combination Moxidectin and Albendazole, Ivermectin and Albendazole and Albendazole Alone in Adolescents and Adults Infected With Trichuris Trichiura: a Randomized Controlled Trial [NCT04726969]Phase 3255 participants (Actual)Interventional2021-06-15Completed
Efficacy, Safety and Pharmacokinetics of Moxidectin and Its Comparison to Ivermectin Against Strongyloides Stercoralis in Adults: a Randomized Controlled Non-inferiority Trial [NCT04848688]Phase 3332 participants (Actual)Interventional2022-02-05Completed
A Randomized, Single-Ascending Dose, Ivermectin-Controlled, Double-Blind, Safety, Tolerability, Pharmacokinetic, and Efficacy Study Of Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection [NCT00300768]Phase 2172 participants (Actual)Interventional2006-09-06Completed
A Randomized, Double Blind, Parallel Group Clinical Trial to Evaluate the Safety of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lym [NCT04311671]Phase 312,500 participants (Anticipated)Interventional2021-05-03Recruiting
An Open-label Study of the Pharmacokinetics and Safety of a Single Dose of Moxidectin Per Oral in Subjects Aged 4 to 17 Years With (or at Risk of) Onchocerciasis to Identify an Optimal Dose for Treatment of Children 4 to 11 Years [NCT03962062]Phase 136 participants (Actual)Interventional2021-03-29Completed
Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura in Adolescents: a Randomized Controlled Trial [NCT03501251]Phase 2286 participants (Actual)Interventional2018-07-03Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT03012828 (4) [back to overview]Concentrations of Moxidectin in Plasma
NCT03012828 (4) [back to overview]Mean Change From Baseline in QTc Interval (Corrected by Friderica's Formula, dQTcF) Associated With Plasma Moxidectin Concentrations After a Single Dose
NCT03012828 (4) [back to overview]Subjects With Categorical Changes From Baseline in 12-lead Electrocardiograms (ECGs)
NCT03012828 (4) [back to overview]Change From Baseline in Heart Rate (HR) and Duration of Other Interval Parameters (PR and QRS)
NCT03905265 (4) [back to overview]Analysis of Moxidectin Maximum Plasma Concentrations (Cmax)
NCT03905265 (4) [back to overview]Analysis of Moxidectin Plasma Concentrations
NCT03905265 (4) [back to overview]Mortality Rate for Adult Scabies Mites
NCT03905265 (4) [back to overview]Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set)
NCT04726969 (12) [back to overview]Cure Rate (CR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura
NCT04726969 (12) [back to overview]Cure Rate (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura
NCT04726969 (12) [back to overview]Cure Rates (CRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants
NCT04726969 (12) [back to overview]Cure Rates (CRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants
NCT04726969 (12) [back to overview]Egg Reduction Rate (ERR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura
NCT04726969 (12) [back to overview]Egg Reduction Rate (ERR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura
NCT04726969 (12) [back to overview]Egg Reduction Rates (ERRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants
NCT04726969 (12) [back to overview]Egg Reduction Rates (ERRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants
NCT04726969 (12) [back to overview]Adverse Events (AEs)
NCT04726969 (12) [back to overview]Concentrations of Albendazole and Ivermectin/Albendazole Combination in Adolescents (Aged 12 to 20 Years)
NCT04726969 (12) [back to overview]Concentrations of Albendazole and Ivermectin/Albendazole Combination in Adolescents (Aged 12 to 20 Years)
NCT04726969 (12) [back to overview]Exploratory Outcome: Number of Participants Within Each Blood Type Category (A, B, AB and 0)

Concentrations of Moxidectin in Plasma

Concentrations of moxidectin in plasma were assessed by collection of plasma samples at pre-specified intervals after oral dosing with moxidectin. The concentration of moxidectin was determined using a validated LC MS/MS method.The pharmacokinetic time points coincided with ECG collection timepoints (within 5 minutes and no later than 10 minutes after ECG recordings). Plasma PK parameters were estimated from the concentration measurements, including maximum concentration (Cmax) for each individual and mean for each dose cohort. (NCT03012828)
Timeframe: Pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12*, 24, 36, 48, 60, and 72 hours and days 8,15 and 22 post dosing

Interventionnanogram/milliliter (Geometric Mean)
Moxidectin 4mg27.2
Moxidectin 8mg56.7
Moxidectin 16mg133
Moxidectin 24mg176
Moxidectin 36mg247

[back to top]

Mean Change From Baseline in QTc Interval (Corrected by Friderica's Formula, dQTcF) Associated With Plasma Moxidectin Concentrations After a Single Dose

Triplicate 10-second ECG recordings taken 1 minute apart using a Mortara continuous 12-lead digital ECG recorder connected to each subject during the Baseline to 72-hour post dose confinement period. Baseline only and baseline and placebo adjusted changes in QTc interval (corrected using the Friderica formula, QTcF) at each timepoint for each dose level were determined. The mean change from baseline (without and with placebo correction, dQTcF and ddQTcF respectively) at each of the 14 time points was calculated for each dose level. The primary outcome measure was the mean dQTcF for all subjects(the dQTcF gradient). The mean dQTcF for each active treatment group was determined at each post dose timepoint but the mean dQTcF by dose level was not calculated. The mean dQTcF at approximate moxidectin Tmax (hour 3 or hour 4) for each active treatment group and at hour 3 for the placebo group is reported. (NCT03012828)
Timeframe: Baseline (pre-dose) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, and 72 hours post dosing

Interventionmillseconds (Mean)
Moxidectin 4mg-5.1
Moxidectin 8mg-4.5
Moxidectin 16mg-4.5
Moxidectin 24mg-6.3
Moxidectin 36mg-3.9
Placebo-2.9
All Subjects-0.0077

[back to top]

Subjects With Categorical Changes From Baseline in 12-lead Electrocardiograms (ECGs)

Changes from baseline in QTcF exceeding regulatory standard categorical limits (> 30msec change or exceeding 450msec). Report applies to changes of 30msec - NCT03012828)
Timeframe: At Baseline and Days 1, 2, 3, 4, 22 and Week 12

Interventionparticipants (Number)
Moxidectin 4mg1
Moxidectin 8mg0
Moxidectin 16mg0
Moxidectin 24mg0
Moxidectin 36mg1
Placebo1

[back to top]

Change From Baseline in Heart Rate (HR) and Duration of Other Interval Parameters (PR and QRS)

Changes from Baseline were assessed at each timepoint up to 72 hours post dose. Mean changes across the 72 hour assessment period for each parameter were calculated for each moxidectin group and the placebo group and for the population overall. (NCT03012828)
Timeframe: Baseline (pre-dose) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, and 72 hours post dosing

,,,,,,
Interventionmilliseconds (Mean)
Change in Heart rate (HR)Change in PR intervalChange in QRS interval
All Subjects-0.005-0.0020.004
Moxidectin 16mg-1.1-2.10.4
Moxidectin 24mg-3.64.6-0.8
Moxidectin 36mg-1.5-3.50.4
Moxidectin 4mg-1.02.2-1.6
Moxidectin 8mg0.5-0.1-0.7
Placebo-2.9-1.81.2

[back to top]

Analysis of Moxidectin Maximum Plasma Concentrations (Cmax)

The final PK analysis dataset included a total of 240 evaluable PK samples from 22 subjects. All pre-dose samples were below the limit of quantitation (BQL). (NCT03905265)
Timeframe: Nominal time of PK sample collection was Pre-dose, 2hours (h), 3h, 4h, 8h, Day 1 (24h), Day 2 (48h), Day 3 (72h), Day 7 (168h), Day 14 (336h) and Day 28 (672h)

InterventionCmax (ng/mL) (Geometric Mean)
Moxidectin 2 mg21.0
Moxidectin 8 mg73.5
Moxidectin 20 mg207
Moxidectin 36 mg277

[back to top]

Analysis of Moxidectin Plasma Concentrations

The final PK analysis dataset included a total of 240 evaluable PK samples from 22 subjects. All pre-dose samples were below the limit of quantitation (BQL). (NCT03905265)
Timeframe: Nominal time of PK sample collection was Pre-dose, 2hours (h), 3h, 4h, 8h, Day 1 (24h), Day 2 (48h), Day 3 (72h), Day 7 (168h), Day 14 (336h) and Day 28 (672h)

,,,
Interventionhr*ng/mL (Geometric Mean)
AUC0-24 (hr*ng/mL)AUC0-48 (hr*ng/mL)AUC0-72 (hr*ng/mL)AUC0-D7 (hr*ng/mL)AUC0-D14 (hr*ng/mL)AUC0-D28 (hr*ng/mL)
Moxidectin 2 mg181212229276329408
Moxidectin 20 mg167020002200278035304670
Moxidectin 36 mg293035603900477058207430
Moxidectin 8 mg744903989123015401970

[back to top]

Mortality Rate for Adult Scabies Mites

Adult scabies mite death was based on the reflectance confocal microscopy (RCM) morphology assessment of 2 live adult scabies mites nominated pre-treatment (Baseline), hence overall number of units analyzed are different from the overall number of participants. For the outcome measure, the number of adult mites assessed at each timepoint is the sum of the number of adult mites from all participants in the analysis population for each dose. Therefore, mortality was assessed in 2 mites in the 2 mg group, 6 in the 8 mg group, 8 in the 20 mg group and 14 in the 32 mg group. Adult mite death was defined as the degradation (homogenization of internal structures and/or external anatomic structures, and increased reflectance) of the adult mite observed by RCM. The number of dead mites was assessed at Hours 4, 8, 24, 48 and 72, and Days 7, 14 and 28 compared to the baseline adult mites. (NCT03905265)
Timeframe: 28 days

,,,
InterventionAdult mites (Number)
Number of live adult mites assessed at BaselineNumber of dead adult mites assessed at Day 0-4 hours timepointNumber of dead adult mites assessed at Day 0-8 hours timepointNumber of dead adult mites assessed at Day 1 timepointNumber of dead adult mites assessed at Day 2 timepointNumber of dead adult mites assessed at Day 3 timepointNumber of dead adult mites assessed at Day 7 timepointNumber of dead adult mites assessed at Day 14 timepointNumber of dead adult mites assessed at Day 28 timepoint
Moxidectin 2 mg200000000
Moxidectin 20 mg800012488
Moxidectin 36 mg140002391214
Moxidectin 8 mg601222456

[back to top]

Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set)

No formal statistical analysis of AEs was undertaken. Adverse events reported in this Section refer to treatment emergent adverse events (TEAE), defined as AEs that started, or worsened, on or after the start of the administration of Investigational Product (Moxidectin). Moxidectin was generally well tolerated, with no treatment-related SAEs reported and no treatment emergent adverse event (TEAEs) leading to study withdrawal or resulting in death. Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term. Data up to and including the Day 28 assessment for each subject. (NCT03905265)
Timeframe: Day 0 to Day 28 inclusive

,,,
InterventionParticipants (Count of Participants)
Infections and infestationsSkin and subcutaneous tissue disorderNervous system disordersPsychiatric disordersGastrointestinal disorders
Moxidectin 2 mg31220
Moxidectin 20 mg51111
Moxidectin 36 mg54300
Moxidectin 8 mg32001

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Cure Rate (CR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura

The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. (NCT04726969)
Timeframe: 14-21 days after treatment

Interventionpercentage of participants (%) (Number)
Arm B: Albendazole13.4
Arm C: Ivermectin and Albendazole22.5

[back to top]

Cure Rate (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura

The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. (NCT04726969)
Timeframe: 14-21 days after treatment

Interventionpercentage of participants (%) (Number)
Arm A: Moxidectin and Albendazole15.3
Arm B: Albendazole13.4

[back to top]

Cure Rates (CRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants

The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. (NCT04726969)
Timeframe: 14-21 days after treatment

Interventionpercentage of participants (%) (Number)
Arm A: Moxidectin and Albendazole95.5
Arm B: Albendazole95.5
Arm C: Ivermectin and Albendazole100

[back to top]

Cure Rates (CRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants

The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. (NCT04726969)
Timeframe: 14-21 days after treatment

Interventionpercentage of participants (%) (Number)
Arm A: Moxidectin and Albendazole100
Arm B: Albendazole37.5
Arm C: Ivermectin and Albendazole20.0

[back to top]

Egg Reduction Rate (ERR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. (NCT04726969)
Timeframe: 14-21 days after treatment

Interventionpercent change (Mean)
Arm B: Albendazole60.2
Arm C: Ivermectin and Albendazole81.5

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Egg Reduction Rate (ERR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. (NCT04726969)
Timeframe: 14-21 days after treatment

Interventionpercent change (Geometric Mean)
Arm A: Moxidectin and Albendazole67.0
Arm B: Albendazole60.2

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Egg Reduction Rates (ERRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the three treatment arms before and after treatment to assess the corresponding ERRs. (NCT04726969)
Timeframe: 14-21 days after treatment

Interventionpercent change (Mean)
Arm A: Moxidectin and Albendazole100
Arm B: Albendazole100
Arm C: Ivermectin and Albendazole100

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Egg Reduction Rates (ERRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants

Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the three treatment arms before and after treatment to assess the corresponding ERRs. (NCT04726969)
Timeframe: 14-21 days after treatment

Interventionpercent change (Mean)
Arm A: Moxidectin and Albendazole100
Arm B: Albendazole95.7
Arm C: Ivermectin and Albendazole90.7

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Adverse Events (AEs)

Participants will be monitored at the site for 3 hours following treatment for any acute AEs and reassessment will be done at 24h post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs. (NCT04726969)
Timeframe: 3 hours, 24 hours and 14-21 days after treatment

,,
InterventionParticipants (Count of Participants)
3 hours: Headache3 hours: Abdominal pain3 hours: Nausea3 hours: Diarrhea3 hours: Itching3 hours: Symptoms related to immune system activation24 hours: Headache24 hours: Abdominal pain24 hours: Nausea24 hours: Diarrhea24 hours: Itching24 hours: Symptoms related to immune system activation14-21 days: Headache14-21 days: Abdominal pain14-21 days: Nausea14-21 days: Diarrhea14-21 days: Itching14-21 days: Symptoms related to immune system activation
Arm A: Moxidectin and Albendazole143213481591000000
Arm B: Albendazole562165950485000000
Arm C: Ivermectin and Albendazole7821256123743000000

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Concentrations of Albendazole and Ivermectin/Albendazole Combination in Adolescents (Aged 12 to 20 Years)

For characterization of population pharmacokinetics (PK) and drug-drug interaction parameters ivermectin, albendazole and its metabolites will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a lower limit of quantification of 1-5 ng/ml. (NCT04726969)
Timeframe: 0 to 24 hours after treatment

Interventionng/ml (Median)
cmax (albendazole) [ng/ml]
Arm B: Albendazole26.5

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Concentrations of Albendazole and Ivermectin/Albendazole Combination in Adolescents (Aged 12 to 20 Years)

For characterization of population pharmacokinetics (PK) and drug-drug interaction parameters ivermectin, albendazole and its metabolites will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a lower limit of quantification of 1-5 ng/ml. (NCT04726969)
Timeframe: 0 to 24 hours after treatment

Interventionng/ml (Median)
cmax (albendazole) [ng/ml]cmax (ivermectin) [ng/ml]
Arm C: Ivermectin and Albendazole26.540.1

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Exploratory Outcome: Number of Participants Within Each Blood Type Category (A, B, AB and 0)

Blood type of participants will be collected during clinical examination prior treatment using blood type determination cards. (NCT04726969)
Timeframe: before treatment, i.e. at enrolment

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InterventionParticipants (Count of Participants)
Blood type 0Blood type ABlood type BBlood type AB
Arm A: Moxidectin and Albendazole4820152
Arm B: Albendazole4718163
Arm C: Ivermectin and Albendazole4712243

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