Nalmefene
As of the edition of 20 October 2026, Nalmefene is a small molecule: marketed, first approved in 1995 (US); acts on OPRK1 and OPRM1; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Revex
- First approved
- 17 April 1995 (US)
- Approvals on record
- 7 in 3 regions
- Holder of the most recent approval
- Knoa Pharma; 5 holders in all
- Registered trials
- 35, 6 stopped early
- Disease areas
- Mental health; Chemically induced; Immune system; Skin and connective tissue; Urinary and reproductive; Digestive system
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Knoa Pharma holds a later exclusivity on its own new formulation or combination product, ending 2027; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
9 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product9 company-target rows are on route B because of Nalmefene.
See the 9 company-target rows 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 | 3 | 2 | 0 | 0 |
| Phase 1 | 13 | 11 | 0 | 2 |
| Phase 2 | 6 | 4 | 1 | 0 |
| Phase 3 | 9 | 6 | 1 | 2 |
| Phase 4 | 4 | 2 | 0 | 2 |
| All trials | 35 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Lundbeck | Applicant and Lead sponsor of trials | 2008 to now |
| Otsuka | Applicant and Lead sponsor of trials | 2015 to now |
| Indivior | Later holder and Lead sponsor of trials | 2021 to now |
| Hikma Pharmaceuticals | Acquired holder | 2022 to now |
| Purdue Pharma | Later holder and Lead sponsor of trials | 2022 to now |
| Knoa Pharma | Acquired holder | 2026 to now |