Sufentanil
As of the edition of 20 October 2026, Sufentanil is a small molecule: marketed, first approved in 1984 (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 2018
- Kind
- Small molecule
- Brand name
- Sufenta Preservative Free
- First approved
- 4 May 1984 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Vertical Pharmaceuticals; 4 holders in all
- Registered trials
- 135, 12 stopped early
- Disease areas
- Nervous system; Digestive system; Inherited and neonatal; Mental health; Cancer; Urinary and reproductive
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Sufentanil.
See the 2 companies 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 | 61 | 34 | 10 | 4 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 9 | 6 | 1 | 2 |
| Phase 3 | 22 | 14 | 2 | 3 |
| Phase 4 | 42 | 23 | 4 | 3 |
| All trials | 135 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Earlier holder | 1984 to now |
| Laboratoire Aguettant | Applicant | 2018 to now |
| Vertical Pharmaceuticals | Acquired holder | 2023 to now |
| Rising Pharma | Acquired holder | 2023 to now |