MOXIDECTIN
Moxidectin is an anthelmintic medication used for patients with onchocerciasis caused by the parasite Onchocerca volvulus. It treats both adults and children aged 4 years and older who weigh at least 13 kg. Because the drug does not kill the adult version of the parasite, healthcare providers should perform follow-up evaluations after use.
How MOXIDECTIN Works
Moxidectin works as an anthelmintic drug to address parasitic infections. It belongs to a class of medications known as macrocyclic lactones.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-06-13
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- TABLET
MOXIDECTIN Approval History
What MOXIDECTIN Treats
1 indicationsMOXIDECTIN is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Onchocerciasis
MOXIDECTIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MOXIDECTIN
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04311671 results posted | MDGH-MOX-3002 | Ph 3 | completed | Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole |
| NCT04410406 results posted | 202005076 | Ph 3 | completed | Moxidectin for LF, Cote d'Ivoire (DOLF) |
| NCT03876262 | MDGH-MOX-3001 | Ph 3 | active not recruiting | Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis |
| NCT07145736 EKAIO | KirbyI | Ph 4 | recruiting | Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases |
| NCT03962062 results posted | MDGH-MOX-1006 | Ph 1 | completed | A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years |
| NCT04056325 StrongMoxi results posted | 3 | Ph 2, Ph 3 | completed | Efficacy, Safety, and PK of Ascending Dosages of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis |
| NCT03012828 results posted | MDGH-MOX-1008 | Ph 1 | completed | Effect of a Single Oral Dose of Moxidectin on the Cardiac QT Interval of Healthy Volunteers |
| NCT00790998 | 3110A1-3000 B1751006 - ONCBL60801 | Ph 3 | completed | Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection |
| NCT01035619 | B1751005 3110A1-2201 | Ph 2 | withdrawn | Pediatric Pharmacokinetics And Safety Study Of Moxidectin |
| NCT00736697 | 3110A1-1005 | Ph 1 | completed | Study Evaluating The Effect Of High-Fat Meal On Bioavailability And Pharmacokinetics Of Single Dose Of Moxidectin |
| NCT00856362 | 3110A1-1004 | Ph 1 | completed | Study Evaluating The Co-Administration Of Moxidectin And Midazolam In Healthy Subjects |
| NCT00751764 | 3110A1-1002 | Ph 1 | completed | Study Evaluating The Excretion Of Moxidectin Into The Breast Milk Of Lactating, Non-Breastfeeding Women |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MOXIDECTIN FDA Label Details
Indications & Usage
FDA Label (PDF)MOXIDECTIN is indicated for the treatment of Onchocerciasis.
MOXIDECTIN Patents & Exclusivity
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment