Numerous clinical trials spanning Phase 1 through Phase 4 evaluate moxidectin against parasitic infections, including onchocerciasis, scabies, loiasis, strongyloidiasis, and soil-transmitted helminthiasis. Supported by non-profit, academic, and pharmaceutical sponsors, trial recruitment statuses range from recruiting and active not recruiting to completed studies evaluating efficacy and safety. Overall, this clinical landscape highlights moxidectin as a critical macrocyclic lactone candidate for global health initiatives targeting neglected tropical diseases.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07145736 | RECRUITING | Onchocerciasis; Ascaris Lumbricoides Infection; Trichuris Trichiura; Infection; Hookworm Infections; Scabies |
Kirby Institute |
2025-08-04 | PHASE4 |
| NCT07159373 | NOT_YET_RECRUITING | Lymphatic Filariasis; Scabies; Strongyloidiasis |
Medicines Development for Global Health |
2026-03 | PHASE3 |
| NCT06070116 | ACTIVE_NOT_RECRUITING | Onchocercal Subcutaneous Nodule; Onchocerciasis; Onchocerciasis, Ocular; Onchocerca Infection; Tropical Disease |
Washington University School of Medicine |
2024-04-05 | PHASE2 |
| NCT06795165 | COMPLETED | Blepharitis |
Eye Research Foundation, Inc. |
2025-02-02 | PHASE4 |
| NCT05875441 | COMPLETED | Scabies |
Medicines Development for Global Health |
2023-11-23 | PHASE2 |
| NCT04410406 | COMPLETED | Lymphatic Filariasis |
Washington University School of Medicine |
2020-08-20 | PHASE3 |
| NCT04311671 | COMPLETED | Onchocerciasis |
Medicines Development for Global Health |
2021-05-03 | PHASE3 |
| NCT06188715 | COMPLETED | Trichuriasis; Ascariasis; Hookworm Infections |
Jennifer Keiser |
2024-05-14 | PHASE3 |
| NCT03876262 | ACTIVE_NOT_RECRUITING | Onchocerciasis |
Medicines Development for Global Health |
2021-05-03 | PHASE3 |
| NCT04049851 | COMPLETED | Onchocerciasis, Ocular; Loiasis |
Center for Research on Filariasis and Other Tropical Diseases, Cameroon |
2022-04-07 | PHASE2 |
| NCT04848688 | COMPLETED | Strongyloides Stercoralis Infection |
Jennifer Keiser |
2022-02-05 | PHASE3 |
| NCT03962062 | COMPLETED | Onchocerciasis |
Medicines Development for Global Health |
2021-03-29 | PHASE1 |
| NCT03905265 | COMPLETED | Scabies |
Medicines Development for Global Health |
2020-01-13 | PHASE2 |
| NCT04726969 | COMPLETED | Trichuriasis; Ascariasis; Hookworm Infections |
Jennifer Keiser |
2021-06-15 | PHASE3 |
| NCT04700423 | COMPLETED | Trichuriasis; Ascariasis; Hookworm Infections; Helminthes; Infestation, Intestinal |
Jennifer Keiser |
2021-03-01 | PHASE2; PHASE3 |
| NCT03876262 | Active not recruiting | Onchocerciasis |
Medicines Development for Global Health |
2021-05-03 | Phase 3 |
| NCT04056325 | COMPLETED | Strongyloides Stercoralis Infection |
Jennifer Keiser |
2019-11-27 | PHASE2; PHASE3 |
| NCT03962062 | Completed | Onchocerciasis |
Medicines Development for Global Health |
2021-03-29 | Phase 1 |
| NCT03905265 | Completed | Scabies |
Medicines Development for Global Health |
2020-01-13 | Phase 2 |
| NCT03501251 | COMPLETED | Trichuris Trichiura; Infection |
Swiss Tropical & Public Health Institute |
2018-07-03 | PHASE2 |
| NCT03012828 | COMPLETED | QT Effects in Healthy Volunteers |
Medicines Development for Global Health |
2017-01 | PHASE1 |
| NCT00790998 | COMPLETED | Onchocerciasis |
Medicines Development for Global Health |
2009-04 | PHASE3 |
| NCT01035619 | WITHDRAWN | Onchocerciasis |
Pfizer |
2011-04 | PHASE2 |
| NCT00300768 | COMPLETED | Onchocerciasis |
Medicines Development for Global Health |
2006-09-06 | PHASE2 |
| NCT00751764 | COMPLETED | Infection |
Wyeth is now a wholly owned subsidiary of Pfizer |
2008-11 | PHASE1 |
| NCT00856362 | COMPLETED | Healthy |
Wyeth is now a wholly owned subsidiary of Pfizer |
2009-04 | PHASE1 |
| NCT00736697 | COMPLETED | Infection |
Wyeth is now a wholly owned subsidiary of Pfizer |
2008-11 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2025-11-21)
Check the
Moxidectin
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.