Omacetaxine mepesuccinate
As of the edition of 20 October 2026, Omacetaxine mepesuccinate is a small molecule: marketed, first approved in 2012 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Synribo
- First approved
- 26 October 2012 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Teva
- Registered trials
- 49, 10 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Urinary and reproductive; Inherited and neonatal
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 0 | 2 | 0 |
| Phase 1 | 5 | 3 | 1 | 1 |
| Phase 2 | 31 | 10 | 10 | 8 |
| Phase 3 | 9 | 0 | 7 | 1 |
| All trials | 49 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Teva | Originator, Applicant and Lead sponsor of trials | 2006 to now |