Multiple clinical trials across Phase 1, Phase 2, and Phase 3 evaluate emodepside to establish its safety, efficacy, and pharmacokinetics in healthy volunteers and patients with neglected tropical parasitic diseases, including strongyloidiasis, hookworm, Trichuris trichiura, Ascaris lumbricoides, filariasis, and onchocerciasis. Key sponsors driving these evaluations include the Swiss Tropical and Public Health Institute, the Drugs for Neglected Diseases initiative, Bayer, and the Bill & Melinda Gates Foundation. With recruitment statuses ranging from not yet recruiting to active and completed, these studies aim to advance nematode therapeutics.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06800248 | NOT_YET_RECRUITING | Trichuris Trichiura; Infection; Hookworm Infection; Ascaris Lumbricoides Infection |
Swiss Tropical & Public Health Institute |
2026-11-06 | PHASE3 |
| NCT07258173 | NOT_YET_RECRUITING | Trichuris Infection |
Jennifer Keiser |
2026-11-15 | PHASE2 |
| NCT05180461 | ACTIVE_NOT_RECRUITING | Onchocerciasis |
Drugs for Neglected Diseases |
2021-08-30 | PHASE2 |
| NCT06736691 | ACTIVE_NOT_RECRUITING | Trichuris Trichiura; Infection; Hookworm Infection; Ascaris Lumbricoides Infection |
Swiss Tropical & Public Health Institute |
2025-11-25 | PHASE3 |
| NCT06373835 | COMPLETED | Strongyloides Stercoralis Infection; Strongyloidiasis |
Swiss Tropical & Public Health Institute |
2024-05-20 | PHASE2 |
| NCT06412926 | COMPLETED | Soil-transmitted Helminth Infection; Onchocerciasis (River Blindness) |
Bayer |
2024-05-07 | PHASE1 |
| NCT06373835 | Not yet recruiting | Strongyloides Stercoralis Infection|Strongyloidiasis |
Swiss Tropical & Public Health Institute|National Institute of Public Health Vientiane Laos |
2024-05-01 | Phase 2 |
| NCT05538767 | COMPLETED | Hookworm Infections |
Jennifer Keiser |
2022-09-16 | PHASE2 |
| NCT05538767 | Completed | Hookworm Infections |
Jennifer Keiser|Public Health Laboratory Ivo de Carneri|Swiss Tropical & Public Health Institute |
2022-09-16 | Phase 2 |
| NCT05017194 | COMPLETED | Trichuris Trichiura; Infection; Hookworm Infections |
Jennifer Keiser |
2021-08-02 | PHASE2 |
| NCT05017194 | Completed | Trichuris Trichiura; Infection|Hookworm Infections |
Jennifer Keiser|Public Health Laboratory Ivo de Carneri|Swiss Tropical & Public Health Institute |
2021-08-02 | Phase 2 |
| NCT03383614 | COMPLETED | Filariasis |
Drugs for Neglected Diseases |
2017-11-14 | PHASE1 |
| NCT03383523 | COMPLETED | Filariasis |
Drugs for Neglected Diseases |
2017-10-26 | PHASE1 |
| NCT03383614 | Completed | Filariasis |
Drugs for Neglected Diseases|Bayer|Bill and Melinda Gates Foundation |
2017-11-14 | Phase 1 |
| NCT03383523 | Completed | Filariasis |
Drugs for Neglected Diseases|Bayer|Bill and Melinda Gates Foundation |
2017-10-26 | Phase 1 |
| NCT02661178 | COMPLETED | Healthy Volunteers |
Drugs for Neglected Diseases |
2015-12 | PHASE1 |
| NCT02661178 | Completed | Healthy Volunteers |
Drugs for Neglected Diseases|Bayer|Bill and Melinda Gates Foundation |
2015-12 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-08-14)
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>).