Drugs / Moxidectin
Moxidectin
also known as
MOX · CL 301,423 · Moxidectin component of advocate · Moxidectin for veterinary use · Moxidectina · Moxidectine · NSC-760424
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | MOXIDECTIN | — | 2025-02-07 | fda.gov ↗ |
| Approved | US (FDA) | MOXIDECTIN | — | 2018-06-13 | fda.gov ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT03962062 | Mar 2021 → May 2022 | onchocerciasis | Medicines Development for Global Health | Completed | No outcome recorded |
| Phase 1 | NCT03012828 | Jan → Mar 2017 | — | Medicines Development for Global Health | Completed | No outcome recorded |
| Phase 1 | NCT00856362 | Apr → Sep 2009 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00751764 | Nov 2008 → Sep 2009 | infectious disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00736697 | Nov 2008 → May 2009 | infectious disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT06070116 | Apr 2024 → Sep 2026 overdue | ocular onchocerciasis | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05875441 | Nov 2023 → Nov 2024 | scabies | Medicines Development for Global Health | Completed | No outcome recorded |
| Phase 2 | NCT04049851 | Apr 2022 → Jul 2023 | loiasis, ocular onchocerciasis | Center for Research on Filariasis and Other Tropical Diseases, Cameroon | Completed | No outcome recorded |
| Phase 2 | NCT03905265 | Jan 2020 → Feb 2022 | scabies | Medicines Development for Global Health | Completed | No outcome recorded |
| Phase 2 | NCT03501251 | Jul → Aug 2018 | trichuriasis | Swiss Tropical & Public Health Institute | Completed | No outcome recorded |
| Phase 2 | NCT01035619 | Apr 2011 | onchocerciasis | Pfizer | Withdrawn | No outcome recorded |
| Phase 2 | NCT00300768 | Sep 2006 → Nov 2009 | onchocerciasis | Medicines Development for Global Health | Completed | No outcome recorded |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT04700423 | Mar → Aug 2021 | ascariasis, hookworm infectious disease, intestinal helminthiasis, trichuriasis | Jennifer Keiser | Completed | Missed primary |
| Phase 2/3 | NCT04056325 | Nov 2019 → Apr 2021 | strongyloidiasis | Jennifer Keiser | Completed | No outcome recorded |
| Phase 37 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT07159373 | Sep 2026 → Jun 2027 expected | filariasis, scabies, strongyloidiasis | Medicines Development for Global Health | Recruiting | No outcome recorded |
| Phase 3 | NCT06188715 | May → Aug 2024 | ascariasis, hookworm infectious disease, trichuriasis | Jennifer Keiser | Completed | Met primary |
| Phase 3 | NCT04848688 | Feb → Jul 2022 | strongyloidiasis | Jennifer Keiser | Completed | Met primary |
| Phase 3 | NCT04726969 | Jun → Sep 2021 | ascariasis, hookworm infectious disease, trichuriasis | Jennifer Keiser | Completed | Missed primary |
| Phase 3 | NCT04311671 | May 2021 → Sep 2024 | onchocerciasis | Medicines Development for Global Health | Completed | No outcome recorded |
| Phase 3 | NCT03876262 | May 2021 → Jul 2024 overdue | onchocerciasis | Medicines Development for Global Health | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00790998 | Apr 2009 → Feb 2012 | onchocerciasis | Medicines Development for Global Health | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07145736 | Aug 2025 → Mar 2029 expected | ascariasis, hookworm infectious disease, onchocerciasis, scabies +1 | Kirby Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT06795165 | Feb → Apr 2025 | blepharitis | Eye Research Foundation, Inc. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT04410406 Comparator | Aug 2020 → Oct 2024 | filariasis | Washington University School of Medicine | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2025-09-08 | Medicines Development for Global Health | Regulatory Medicines Development for Global Health announces inclusion of moxidectin on World Health Organization Essential Medicines Lists medicinesdevelopment.com ↗
Melbourne, Australia Medicines Development for Global Health today announced that moxidectin has been included in the 2025 World Health Organization Model List of Essential Medicines and Model List of Essential Medicines for Children as a therapeutic alternative to ivermectin for the treatment of river blindness (onchocerciasis) and lymphatic filariasis. |
| 2025-02-20 | Medicines Development for Global Health | Regulatory U.S. FDA expands indication for moxidectin to treat river blindness in children as young as four medicinesdevelopment.com ↗
Melbourne, Australia Medicines Development for Global Health (MDGH) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for moxidectin 2mg tablets for the treatment of river blindness (onchocerciasis) in children aged four years and older and weighing at least 13 kg. |
| 2024-12-05 | Medicines Development for Global Health | Regulatory Ghana becomes first river blindness-endemic country to approve moxidectin medicinesdevelopment.com ↗
Ghana is the first river blindness-endemic country to grant regulatory approval of moxidectin, clearing the way for the planned community pilot treatment implementation program, MOMENTUM, to begin in the Twifo Atti-Morkwa district in January 2025. |
| 2023-10-19 | Medicines Development for Global Health | Results New modelling study suggests potential for moxidectin to accelerate elimination of river blindness in Africa medicinesdevelopment.com ↗
Furthermore, 6-monthly dosing of moxidectin may be the only strategy to achieve elimination of transmission in areas of high endemicity. |
| 2022-12-21 | Medicines Development for Global Health | Results American Society of Tropical Medicine and Hygiene Annual Meeting medicinesdevelopment.com ↗
They also note that moxidectin plus albendazole efficacy at 12 months is similar to ivermectin plus albendazole and diethylcarbamazine (IDA) and moxidectin plus albendazole and diethylcarbamazine (MoxDA) combinations. |
| 2021-12-18 | Medicines Development for Global Health | Results MDGH Update - December 2021 medicinesdevelopment.com ↗
Although the data are preliminary and the analysis was of a small subset of the study population, moxidectin combination therapies were well tolerated and the efficacy observed warrants further evaluation. |
| 2018-06-13 | Medicines Development for Global Health | Regulatory U.S. FDA approves Moxidectin for the treatment of River Blindness medicinesdevelopment.com ↗
Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved moxidectin 8 mg oral for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older1. |
| 2018-02-19 | Medicines Development for Global Health | Results Moxidectin phase III study Lancet publication medicinesdevelopment.com ↗
Moxidectin would therefore be expected to reduce parasite transmission between treatment rounds more than ivermectin could, thus accelerating progress towards elimination |
| 2017-12-16 | Medicines Development for Global Health | Regulatory Medicines Development for Global Health announces submission of the Moxidectin NDA to the FDA and priority review designation medicinesdevelopment.com ↗
With the designation, the FDA now aims to review the moxidectin registration application within six months (compared with a standard review period of 10 months). |
All press releases naming this drug 24 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Moxidectin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04311671 ↗ |
| Known as | CL 301,423 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2104415 ↗ |
| Known as | MOX | “Participants will be given a dose of oral Moxidectin (Mox) (8 mg) plus Albendazole (ALB) (400 mg)” NCT06070116 ↗2“the macrocylic lactone moxidectin (MOX) at 8 mg dosage for onchocerciasis treatment” PMID 38966851 ↗ Apr 2024 “Moxidectin (Mox) 8 mg” NCT04410406 ↗ |
| Known as | Moxidectin component of advocate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2104415 ↗ |
| Known as | Moxidectin for veterinary use | ChEMBL registry synonym — accepted as the source's own label CHEMBL2104415 ↗ |
| Known as | Moxidectina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2104415 ↗ |
| Known as | Moxidectine | ChEMBL registry synonym — accepted as the source's own label CHEMBL2104415 ↗ |
| Known as | NSC-760424 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2104415 ↗ |
| Modality | Other / unclassified | “macrocyclic lactone endectocide” NCT03012828 ↗ |
| Route | Oral | “received a single oral dose of 2 mg (N = 44), 4 mg (N = 45) or 8 mg (N = 38) moxidectin or 150 µg/kg ivermectin (N = 45) with 18 months follow up” PMID 24968000 ↗ Jun 2014 |