Romidepsin

Overview

Romidepsin is a selective inhibitor of histone deacetylase, approved in the US in 2009 for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

Indication

用于在已接受至少1次既往全身治疗的患者中皮肤T-细胞淋巴瘤的治疗(CTCL)。

Associated Conditions

Cutaneous T-Cell Lymphoma (CTCL)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents	2025/05/09	NCT06963346	Phase 1	Recruiting	H. Lee Moffitt Cancer Center and Research Institute
A pilot open label phase I trial to evaluate the safety and the tolerability of a combination of two HIV-1 inducers in HIV+ sub-type B patients under cART with undetectable viral load	2024/10/16	2024-518141-13-00	Phase 1	Recruiting	ANRS Maladies Infectieuses Emergentes
Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas	2021/02/26	NCT04774068	Phase 1	Completed	Walter Hanel
Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL	2021/02/10	NCT04747236	Phase 2	Recruiting	University of Virginia
Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma	2020/11/23	NCT04639843	Phase 1	Withdrawn	National Cancer Institute (NCI)
Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies	2020/06/25	NCT04447027	Phase 1	Active, not recruiting	National Cancer Institute (NCI)
Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer	2020/02/06	NCT04257448	Phase 1	Active, not recruiting	GWT-TUD GmbH
Copanlisib in Combination With Romidepsin in Patients With Relapsed or Refractory Mature T-cell Lymphoma	2020/01/18	NCT04233697	Phase 1	Withdrawn	Columbia University
Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma	2018/12/10	NCT03770000	Phase 1	Completed	Rhizen Pharmaceuticals SA
ISTODAX® for Intravenous Infusion Drug Use Results Survey- Relapsed or Refractory Peripheral T-Cell Lymphoma	2018/11/15	NCT03742921	N/A	Completed	Celgene

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Romidepsin	Teva Parenteral Medicines, Inc.	0703-4004	INTRAVENOUS	5 mg in 1 mL	12/31/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Istodax (romidepsin) 10mg powder for injection vial, and solvent for reconstitution vial	198854	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	8/7/2013
ROMIDEPSIN-REACH romidepsin 10 mg powder for injection vial, and solvent for reconstitution vial	382687	Reach Pharmaceuticals Pty Ltd	Medicine	A	12/13/2022

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