Naltrexone
As of the edition of 20 October 2026, Naltrexone is a small molecule: marketed, first approved in 1984 (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 2018
- Kind
- Small molecule
- Brand name
- Revia
- First approved
- 20 November 1984 (US)
- Approvals on record
- 17 in 3 regions
- Holder of the most recent approval
- Bausch Health; 7 holders in all
- Registered trials
- 317, 43 stopped early
- Disease areas
- Mental health; Chemically induced; Nutrition and metabolism; Nervous system; Immune system; Infections
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
6 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product6 company-target rows are on route B because of Naltrexone.
See the 6 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 | 33 | 24 | 2 | 4 |
| Phase 1 | 46 | 38 | 4 | 3 |
| Phase 2 | 107 | 75 | 14 | 16 |
| Phase 3 | 57 | 40 | 6 | 5 |
| Phase 4 | 74 | 47 | 7 | 15 |
| All trials | 317 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Dupont Merck | Earlier holder | 1984 to now |
| Alkermes | Later holder and Lead sponsor of trials | 2002 to now |
| Orexigen Therapeutics | Applicant and Lead sponsor of trials | 2005 to now |
| Teva | Acquired holder | 2013 to now |
| Bausch Health | Acquired holder | 2018 to now |