Product Description
Romidepsin is a potent and selective inhibitor of histone deacetylases (HDCAi). It is also the only bicyclic inhibitor to undergo clinical assessment and is considered a promising drug for the treatment of T-cell lymphomas. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/28641053/)
Mechanisms of Action: HDAC Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: Australia | Canada | European Medicines Agency | Greece | Israel | Japan | United States
Approved Indications: None
Known Adverse Events: None
Company: Bristol-Myers Squibb
Company Location: NEW YORK NY 10016
Company CEO: Giovanni Caforio
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Belgium, France, United States
Active Clinical Trial Count: 6
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Lymphoma, Non-Hodgkin|Multiple Myeloma|T-Cell Peripheral Lymphoma
Phase 1: Bladder Cancer|HIV Infections|Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Prolymphocytic Leukemia|Prolymphocytic T-Cell Leukemia|T-Cell Cutaneous Lymphoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06963346 |
HERO Trial | P1 |
Recruiting |
Bladder Cancer |
2028-04-01 |
12% |
2025-08-27 |
Primary Endpoints|Start Date|Treatments |
NCT05230368 |
SYNACTHIV | P1 |
Recruiting |
HIV Infections |
2026-04-15 |
2023-02-01 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
NCT02512497 |
OSU-16242 | P1 |
Completed |
Lymphoid Leukemia|Prolymphocytic Leukemia|T-Cell Cutaneous Lymphoma|Prolymphocytic T-Cell Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|T-Cell Peripheral Lymphoma |
2023-10-06 |
50% |
2025-09-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04747236 |
PTCL | P2 |
Recruiting |
T-Cell Peripheral Lymphoma |
2028-06-02 |
39% |
2025-07-08 |
|
NCT01755975 |
NCT01755975 | P2 |
Completed |
Lymphoma, Non-Hodgkin|Multiple Myeloma |
2023-10-01 |
12% |
2024-11-08 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT03547700 |
BTCRC-HEM15-028 | P2 |
Active, not recruiting |
T-Cell Peripheral Lymphoma |
2021-03-01 |
37% |
2024-06-06 |
Primary Endpoints|Treatments |