Secnidazole
As of the edition of 20 October 2026, Secnidazole is a small molecule: marketed, first approved in 1991 (FR); US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Solosec
- First approved
- 13 March 1991 (FR)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- MOKSHA8 BRASIL INDUSTRIA E COMERCIO DE MEDICAMENTOS LTDA; 4 holders in all
- Registered trials
- 11, 1 stopped early
- Disease areas
- Infections; Pregnancy and women's health; Urinary and reproductive; Digestive system
US protection
US protection ends in 2027.
The last listed US exclusivity ends in 2027. The application that gives this date is held by Neothetics.
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 not stated | 1 | 1 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 6 | 5 | 0 | 1 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 11 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Symbiomix Therapeutics | Originator and Lead sponsor of trials | 2014 to now |
| Neothetics | Acquired holder | 2024 to now |