Fexinidazole
As of the edition of 20 October 2026, Fexinidazole is a small molecule: marketed, first approved in 2021 (US); US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- First approved
- 16 July 2021 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Sanofi
- Registered trials
- 12, 2 stopped early
- Disease areas
- Infections; Digestive system; Immune system; Lungs and airways
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Sanofi.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 5 | 4 | 0 | 1 |
| Phase 2 | 2 | 1 | 0 | 1 |
| Phase 3 | 5 | 5 | 0 | 0 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Originator and Lead sponsor of trials | 2021 to now |