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: None *
Approval Status: Approved
Approved Countries: Australia | Canada | European Medicines Agency | Greece | Israel | Japan | United States
Approved Indications: Lymphoma | T-Cell Cutaneous Lymphoma | T-Cell Lymphoma
Known Adverse Events: Anemia | Lymphopenia | Thrombocytopenia | Neutropenia | Anorexia
Company: Bristol-Myers Squibb
Company Location: NEW YORK NY 10016
Company CEO: Giovanni Caforio
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 5
Highest Development Phases
Phase 3: T-Cell Peripheral Lymphoma
Phase 2: Large-Cell Anaplastic Lymphoma|Large-Cell Immunoblastic Lymphoma|Lymphoma, Non-Hodgkin|Multiple Myeloma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| PTCL | P2 |
Recruiting |
T-Cell Peripheral Lymphoma |
2026-06-02 |
|
| NCT01755975 | P2 |
Completed |
Lymphoma, Non-Hodgkin|Multiple Myeloma |
2023-10-01 |
|
| Ro-CHOP_study | P3 |
Completed |
T-Cell Peripheral Lymphoma |
2022-12-13 |
|
| FIL_PTCL13 | P2 |
Active, not recruiting |
Large-Cell Anaplastic Lymphoma|T-Cell Peripheral Lymphoma|Large-Cell Immunoblastic Lymphoma |
2022-11-27 |