Butorphanol
As of the edition of 20 October 2026, Butorphanol is a small molecule: marketed, first approved in 1982 (US); acts on OPRK1 and OPRM1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Small molecule
- Brand name
- Stadol
- First approved
- 1 January 1982 (US)
- Approvals on record
- 4 in 1 region
- Holder of the most recent approval
- Bristol Myers Squibb; 2 holders in all
- Registered trials
- 13, 0 stopped early
- Disease areas
- Nervous system; Lungs and airways; Cancer; Digestive system; Mental health
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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 4 | 6 | 4 | 0 | 0 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Acquired holder and Later holder | 1991 to now |