Fexinidazole Clinical Trials

Size	Price	Qty
5mg	USD 147
100mg	USD 817

Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 3 evaluate fexinidazole for neglected tropical infectious diseases, primarily human African trypanosomiasis and Chagas disease, as well as pharmacokinetic profiles in healthy and hepatic-impaired cohorts. Sponsored independently or jointly by entities such as Sanofi and the Drugs for Neglected Diseases initiative, these studies evaluate safety, dosing regimens, and food effects. While most trials have reached completed status, select studies in challenging environments were ultimately withdrawn or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05645822	Withdrawn	Sleeping Sickness\|Trypanosomiasis African	Institute of Tropical Medicine Belgium\|Ministry of Public Health Democratic Republic of the Congo\|Institut National de Recherche Biomédicale. Kinshasa République Démocratique du Congo\|SANRU Asbl Soins de Santé Primaires en Milieu Rural République Démocratique du Congo\|Drugs for Neglected Diseases	2024-01-01	--
NCT05607173	COMPLETED	Hepatic Function Abnormal	Sanofi	2023-01-18	PHASE1
NCT05607173	Completed	Hepatic Function Abnormal	Sanofi	2023-01-18	Phase 1
NCT03974178	COMPLETED	Trypanosomiasis, African; Sleeping Sickness; Trypanosoma Brucei Rhodesiense; Infection	Drugs for Neglected Diseases	2019-09-29	PHASE2; PHASE3
NCT03025789	COMPLETED	Trypanosomiasis, African; Sleeping Sickness; Trypanosomiasis; Gambian	Drugs for Neglected Diseases	2016-11-10	PHASE3
NCT03587766	COMPLETED	Chagas' Disease (Chronic) Nos	Drugs for Neglected Diseases	2017-11-13	PHASE2
NCT03587766	Completed	Chagas'' Disease (Chronic) Nos	Drugs for Neglected Diseases	2017-11-13	Phase 2
NCT02184689	COMPLETED	Human African Trypanosomiasis (HAT)	Drugs for Neglected Diseases	2014-05-03	PHASE2; PHASE3
NCT01685827	COMPLETED	Human African Trypanosomiasis (HAT); Sleeping Sickness	Drugs for Neglected Diseases	2012-10	PHASE2; PHASE3
NCT03025789	Completed	Trypanosomiasis African\|Sleeping Sickness\|Trypanosomiasis; Gambian	Drugs for Neglected Diseases\|Sanofi	2016-11-10	Phase 3
NCT02169557	COMPLETED	Human African Trypanosomiasis (HAT)	Drugs for Neglected Diseases	2014-04-30	PHASE2; PHASE3
NCT02498782	UNKNOWN	Chagas Disease; Trypanosomiasis, South American; South American Trypanosomiasis; Disease, Chagas	Drugs for Neglected Diseases	2014-07	PHASE2
NCT02571062	COMPLETED	Trypanosomiasis, African	Drugs for Neglected Diseases	2015-03	PHASE1
NCT02571062	Completed	Trypanosomiasis African	Drugs for Neglected Diseases	2015-03	Phase 1
NCT01980199	TERMINATED	Visceral Leishmaniasis	Drugs for Neglected Diseases	2013-11	PHASE2
NCT01483170	TERMINATED	Trypanosomiasis, African	Drugs for Neglected Diseases	2011-09	PHASE1
NCT01340157	COMPLETED	PK in Healthy Volunteers	Drugs for Neglected Diseases	2011-02	PHASE1
NCT01340157	Completed	PK in Healthy Volunteers	Drugs for Neglected Diseases\|Sanofi	2011-02	Phase 1
NCT00982904	COMPLETED	Human African Trypanosomiasis	Drugs for Neglected Diseases	2009-09	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a 5-nitroimidazole derivative, fexinidazole acts as a DNA synthesis inhibitor that undergoes bioactivation to yield reactive intermediates that disrupt protozoal nucleic acid replication. This biochemical interference causes extensive intracellular parasite DNA damage, resulting in effective pathogen clearance and cytotoxic death. Consequently, this antiparasitic mechanism provides the biological basis for its therapeutic use in treating human African trypanosomiasis and Chagas disease.

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>).