Tetrabenazine
As of the edition of 20 October 2026, Tetrabenazine is a small molecule: marketed, first approved in 1996 (CA); acts on SLC18A2; no US protection of its own is listed.
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
- Xenazine
- First approved
- 9 December 1996 (CA)
- Approvals on record
- 20 in 7 regions
- Holder of the most recent approval
- Teva; 8 holders in all
- Registered trials
- 25, 4 stopped early
- Disease areas
- Nervous system; Mental health; Inherited and neonatal
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Teva holds a later exclusivity on its own new formulation or combination product, ending 2033; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Tetrabenazine.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SLC18A2 | Synaptic vesicular amine transporter | Q05940 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 1 | 5 | 3 | 0 | 1 |
| Phase 2 | 2 | 1 | 0 | 1 |
| Phase 3 | 13 | 10 | 1 | 2 |
| Phase 4 | 3 | 1 | 1 | 0 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder and Lead sponsor of trials | 1996 to now |
| Prestwick Pharmaceuticals | Applicant and Lead sponsor of trials | 2008 to now |
| Teva | Later holder and Lead sponsor of trials | 2013 to now |
| Teva | Applicant | 2026 to now |