Active substance
Fexinidazole
- US FDA 1
- WHO EML 2
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FEXINIDAZOLE | 600MG | tablet · oral | SANOFI | Prescription | 16 Jul 2021 |
WHO WHO Model List of Essential Medicines (2025)
- 6.5.5.1.1. Medicines for the treatment of 1st stage African trypanosomiasis · core
Rhodesiense trypanosomiasis; Gambiense trypanosomiasis
Oral > Solid > tablet: 600 mg | Oral > Solid: 600 mg - 6.5.5.1.2. Medicines for the treatment of 2nd stage African trypanosomiasis · core
Rhodesiense trypanosomiasis; Gambiense trypanosomiasis
Oral > Solid > tablet: 600 mg | Oral > Solid: 600 mg
Safety signals and safety-related labeling changes
- US FDA 20 Sep 2024 FEXINIDAZOLE — safety-related labeling change
Labeling sections changed: Contraindications; Adverse Reactions; Drug Interactions; Use in Specific Populations
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.