Romidepsin
As of the edition of 20 October 2026, Romidepsin is a protein: marketed, first approved in 2009 (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 2017
- Kind
- Protein
- Brand name
- Istodax
- First approved
- 5 November 2009 (US)
- Approvals on record
- 6 in 3 regions
- Holder of the most recent approval
- Teva; 3 holders in all
- Registered trials
- 95, 26 stopped early
- Disease areas
- Cancer; Immune system; Blood and lymph; Urinary and reproductive; Heart and blood vessels; Digestive system
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 | 3 | 2 | 0 | 1 |
| Phase 1 | 36 | 26 | 1 | 9 |
| Phase 2 | 54 | 33 | 4 | 15 |
| Phase 3 | 2 | 1 | 0 | 1 |
| All trials | 95 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Applicant, Acquired holder and Lead sponsor of trials | 2003 to now |
| Teva | Later holder | 2020 to now |