Clinical Trials

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)

Check the Emodepside product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Emodepside selectively binds to and activates calcium-dependent SLO-1-like potassium channels in parasitic nematodes, inducing hyperpolarization of neuromuscular cell membranes and blocking pharyngeal pumping and somatic movement. This neuromuscular paralysis prevents nutrient uptake and parasite locomotion, directly driving anthelmintic efficacy in clinical indications such as strongyloidiasis, hookworm infections, filariasis, and onchocerciasis.

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.