Samidorphan
As of the edition of 20 October 2026, Samidorphan is a small molecule: marketed, first approved in 2021 (US); acts on 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 2021
- Kind
- Small molecule
- Brand name
- Lybalvi
- First approved
- 28 May 2021 (US)
- Approvals on record
- 4 in 1 region
- Holder of the most recent approval
- Alkermes
- Registered trials
- 11, 0 stopped early
- Disease areas
- Mental health; Chemically induced
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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 4 | 4 | 0 | 0 |
| Phase 3 | 1 | 0 | 1 | 0 |
| All trials | 11 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Alkermes | Lead sponsor of trials |