Diazepam
As of the edition of 20 October 2026, Diazepam is a small molecule: marketed, first approved in 1962 (CH); acts on GABRA1, GABRA2 and GABRA3 and 4 more; 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 2025
- Kind
- Small molecule
- Brand name
- Valium
- First approved
- 6 April 1962 (CH)
- Approvals on record
- 30 in 7 regions
- Holder of the most recent approval
- Aculys Pharma, Inc.; 12 holders in all
- Registered trials
- 47, 6 stopped early
- Disease areas
- Nervous system; Mental health; Chemically induced; Injuries; Skin and connective tissue; Bones, joints and muscles
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.
Neurelis holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Diazepam.
See the 1 company-target row on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| GABRA1 | Gamma-aminobutyric acid receptor subunit alpha-1 | P14867 |
| GABRG2 | Gamma-aminobutyric acid receptor subunit gamma-2 | P18507 |
| GABRA5 | Gamma-aminobutyric acid receptor subunit alpha-5 | P31644 |
| GABRA3 | Gamma-aminobutyric acid receptor subunit alpha-3 | P34903 |
| GABRA2 | Gamma-aminobutyric acid receptor subunit alpha-2 | P47869 |
| GABRG1 | Gamma-aminobutyric acid receptor subunit gamma-1 | Q8N1C3 |
| GABRG3 | Gamma-aminobutyric acid receptor subunit gamma-3 | Q99928 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 9 | 0 | 1 |
| Phase 1 | 7 | 6 | 0 | 1 |
| Phase 2 | 11 | 7 | 0 | 3 |
| Phase 3 | 8 | 5 | 1 | 1 |
| Phase 4 | 9 | 3 | 1 | 0 |
| All trials | 47 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Later holder and Lead sponsor of trials | 1993 to now |
| Army Medical Research Materiel Command | Acquired holder | 2003 to now |
| Neurelis | Later holder and Lead sponsor of trials | 2016 to now |
| Aquestive Therapeutics | Later holder and Lead sponsor of trials | 2017 to now |
| Bausch Health | Acquired holder | 2019 to now |
| Waylis Therapeutics | Acquired holder | 2022 to now |
| Roche | Later holder |