Stiripentol
As of the edition of 20 October 2026, Stiripentol is a small molecule: marketed, first approved in 2007 (EU); US protection ends in 2029.
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
- Diacomit
- First approved
- 3 January 2007 (EU)
- Approvals on record
- 8 in 4 regions
- Holder of the most recent approval
- MOKSHA8 BRASIL INDUSTRIA E COMERCIO DE MEDICAMENTOS LTDA; 4 holders in all
- Registered trials
- 12, 0 stopped early
- Disease areas
- Nervous system; Pregnancy and women's health; Urinary and reproductive; Inherited and neonatal; Nutrition and metabolism
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029. The application that gives this date is held by Biocodex.
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 product4 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 4 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 2 | 0 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 1 | 0 | 1 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Biocodex | Applicant and Lead sponsor of trials | 2007 to now |
| Meiji Seika Pharma | Applicant | 2012 to now |