Buspirone
As of the edition of 20 October 2026, Buspirone is a small molecule: marketed, first approved in 1986 (US); acts on HTR1A; no US protection is listed.
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
- Buspar
- First approved
- 29 September 1986 (US)
- Approvals on record
- 8 in 1 region
- Holder of the most recent approval
- Bristol Myers Squibb
- Registered trials
- 51, 8 stopped early
- Disease areas
- Mental health; Nervous system; Chemically induced; Injuries; Heart and blood vessels; Ear, nose and throat
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this 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 Buspirone.
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 |
|---|---|---|
| HTR1A | 5-hydroxytryptamine receptor 1A | P08908 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 3 | 1 | 0 |
| Phase 1 | 8 | 6 | 1 | 1 |
| Phase 2 | 18 | 13 | 3 | 2 |
| Phase 3 | 7 | 4 | 0 | 3 |
| Phase 4 | 13 | 8 | 1 | 2 |
| All trials | 51 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Applicant and Earlier holder | 1986 to now |