Treats the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human…. Sold as Fexinidazole. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Fexinidazole (sold as Fexinidazole), first approved Jul 16, 2021, with 0 new uses approved and 1 published complete response letter.
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jul 16, 2021 | FexinidazoleNDA 214429 · New molecular entity | Sanofi | 3 | Marketed |
| Letter | Product | Now |
|---|---|---|
| Nov 12, 2020 | Fexinidazole | Approved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Sanofi