Belinostat

Overview

Belinostat is a novel agent that inhibits the enzyme histone deacetylase (HDAC) with a sulfonamide-hydroxamide structure. It was developed as an orphan drug to target hematological malignancies and solid tumors by TopoTarget. The safety and efficacy of belinostat is currently being evaluated for use in combination with traditional front-line therapies for the treatment of PTCL. Intravenous administration of the agent is available as Beleodaq as monotherapy and the dosing regimen involves a 21-day cycle. It was US-approved in July 2014 as a therapeutic agent for relapsed or refractory peripheral T-cell lymphoma.

Background

Indication

Belinostat is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) with manageable safety profile. It is a potential alternative therapy for patients who did not experience adequate response to first-line drugs for PTCL. It can be used in patients with baseline thrombocytopenia .

Associated Conditions

Refractory Peripheral T-Cell Lymphoma
Relapsed Peripheral T-Cell Lymphoma

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma	2024/08/19	NCT06561048	Phase 3	Recruiting	Corvus Pharmaceuticals, Inc.
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity	2024/05/09	NCT06406465	Phase 2	Recruiting	National Cancer Institute (NCI)
To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL	2023/10/10	NCT06072131	Phase 3	Recruiting	Acrotech Biopharma Inc.
Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment	2022/11/25	NCT05627245	Phase 1	Recruiting	National Cancer Institute (NCI)
Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma	2021/12/27	NCT05170334	Phase 2	Recruiting	H. Lee Moffitt Cancer Center and Research Institute
Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma	2021/12/13	NCT05154994	Phase 1	Recruiting	University of Utah
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
Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer	2021/01/11	NCT04703920	Phase 1	Completed	University of Michigan Rogel Cancer Center
Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma	2020/04/10	NCT04340843	Phase 2	Active, not recruiting	National Cancer Institute (NCI)
Evaluating Safety & Efficacy Belinostat Combo w Nivo Alone & w Ipi in Patients w Treated Metastatic/Advanced Carcinomas w ARID1A Lof Mutation	2020/03/19	NCT04315155	Phase 1	Withdrawn	University of Utah

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Beleodaq	Acrotech Biopharma Inc	72893-002	INTRAVENOUS	500 mg in 10 mL	5/15/2023

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
No TGA approvals found for this drug.

Related News

Corvus Pharmaceuticals Advances Soquelitinib Trials and Reports Q3 2024 Financials

8 months ago

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