Levomethadyl acetate
As of the edition of 20 October 2026, Levomethadyl acetate is a small molecule: marketed, first approved in 1993 (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 1993
- Kind
- Small molecule
- Brand name
- Orlaam
- First approved
- 9 July 1993 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Hikma Pharmaceuticals
- Withdrawn from market
- 1 January 2001 (in some regions)
- Registered trials
- 3, 0 stopped early
- Disease areas
- Chemically induced; Mental health
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| OPRM1 | Mu-type opioid receptor | P35372 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 3 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Hikma Pharmaceuticals | Applicant | 1993 to now |