Vigabatrin
As of the edition of 20 October 2026, Vigabatrin is a small molecule: marketed, first approved in 1990 (FR); acts on ABAT.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Sabril
- First approved
- 25 April 1990 (FR)
- Approvals on record
- 12 in 8 regions
- Holder of the most recent approval
- Pyros Pharmaceuticals; 5 holders in all
- Registered trials
- 21, 6 stopped early
- Disease areas
- Nervous system; Mental health; Chemically induced; Inherited and neonatal; Cancer; Digestive system
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Vigabatrin.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ABAT | 4-aminobutyrate aminotransferase, mitochondrial | P80404 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 3 | 1 | 1 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 7 | 5 | 0 | 2 |
| Phase 3 | 3 | 0 | 0 | 1 |
| Phase 4 | 3 | 1 | 0 | 2 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant | 1992 to now |
| Lundbeck | Applicant and Lead sponsor of trials | 1994 to now |
| Orphelia Pharma | Applicant and Lead sponsor of trials | 2014 to now |
| Pyros Pharmaceuticals | Applicant | 2024 to now |