Valproic acid
As of the edition of 20 October 2026, Valproic acid is a small molecule: marketed, first approved in 1970 (ES); acts on ALDH5A1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1986
- Kind
- Small molecule
- Brand name
- Depakene
- First approved
- 1 January 1970 (ES)
- Approvals on record
- 21 in 6 regions
- Holder of the most recent approval
- Bionpharma; 9 holders in all
- Registered trials
- 270, 48 stopped early
- Disease areas
- Mental health; Nervous system; Cancer; Blood and lymph; Urinary and reproductive; Immune 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
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 Valproic acid.
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 |
|---|---|---|
| ALDH5A1 | Succinate-semialdehyde dehydrogenase, mitochondrial | P51649 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 26 | 20 | 0 | 2 |
| Phase 1 | 67 | 52 | 1 | 11 |
| Phase 2 | 79 | 41 | 7 | 19 |
| Phase 3 | 46 | 31 | 4 | 6 |
| Phase 4 | 52 | 34 | 1 | 10 |
| All trials | 270 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant and Lead sponsor of trials | 1986 to now |
| Abbott | Acquired holder, Earlier holder and Lead sponsor of trials | 2003 to now |
| AbbVie | Acquired holder | 2012 to now |
| Bionpharma | Acquired holder | 2016 to now |
| Kowa | Applicant |