Remifentanil
As of the edition of 20 October 2026, Remifentanil is a small molecule: marketed, first approved in 1996 (US); acts on 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 2006
- Kind
- Small molecule
- Brand name
- Ultiva
- First approved
- 12 July 1996 (US)
- Approvals on record
- 7 in 4 regions
- Holder of the most recent approval
- Johnson & Johnson; 4 holders in all
- Registered trials
- 281, 25 stopped early
- Disease areas
- Nervous system; Lungs and airways; Mental health; Heart and blood vessels; 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 on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Remifentanil.
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 |
|---|---|---|
| OPRM1 | Mu-type opioid receptor | P35372 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 141 | 79 | 15 | 14 |
| Phase 1 | 8 | 6 | 0 | 1 |
| Phase 2 | 13 | 11 | 0 | 1 |
| Phase 3 | 21 | 14 | 1 | 1 |
| Phase 4 | 98 | 61 | 4 | 8 |
| All trials | 281 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Originator and Lead sponsor of trials | 1996 to now |
| Johnson & Johnson | Applicant and Lead sponsor of trials | 2006 to now |
| Viatris | Acquired holder | 2011 to now |