Nalbuphine
As of the edition of 20 October 2026, Nalbuphine is a small molecule: marketed, first approved in 1982 (US); acts on OPRD1, 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
- Nubain
- First approved
- 1 January 1982 (US)
- Approvals on record
- 6 in 1 region
- Holder of the most recent approval
- AbbVie; 2 holders in all
- Registered trials
- 63, 3 stopped early
- Disease areas
- Lungs and airways; Skin and connective tissue; Nervous system; Mental health; Cancer; Injuries
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-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 Nalbuphine.
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
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 20 | 10 | 4 | 3 |
| Phase 1 | 7 | 7 | 0 | 0 |
| Phase 2 | 6 | 4 | 1 | 0 |
| Phase 3 | 13 | 9 | 3 | 0 |
| Phase 4 | 17 | 6 | 6 | 0 |
| All trials | 63 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Abbott | Later holder | 1993 to now |
| AbbVie | Acquired holder | 2012 to now |
| Ph Health | Acquired holder | 2025 to now |
| Dupont Merck | Earlier holder |