Valbenazine
As of the edition of 20 October 2026, Valbenazine is a small molecule: marketed, first approved in 2017 (US); acts on SLC18A2; US protection ends in 2036.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Ingrezza
- First approved
- 11 April 2017 (US)
- Approvals on record
- 8 in 2 regions
- Holder of the most recent approval
- Neurocrine; 2 holders in all
- Registered trials
- 34, 5 stopped early
- Disease areas
- Nervous system; Mental health; Inherited and neonatal
US protection
US protection ends in 2036.
The last listed US drug-substance patent ends in 2036. The application that gives this date is held by Neurocrine.
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 product81 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Valbenazine.
See the 2 companies 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 1 | 4 | 3 | 0 | 1 |
| Phase 2 | 14 | 9 | 3 | 2 |
| Phase 3 | 10 | 8 | 1 | 1 |
| Phase 4 | 6 | 4 | 1 | 1 |
| All trials | 34 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Neurocrine | Originator and Lead sponsor of trials | 2011 to now |
| Mitsubishi Tanabe Pharma | Applicant | 2022 to now |