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Givinostat

Generic Name: Givinostat

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₇N_₃O_₄

CAS Number: 497833-27-9

Unique Ingredient Identifier: 5P60F84FBH

Overview

Givinostat has been used in trials studying the treatment of Polycythemia Vera, Juvenile Idiopathic Arthritis, Duchenne Muscular Dystrophy (DMD), Chronic Myeloproliferative Neoplasms, and Polyarticular Course Juvenile Idiopathic Arthritis.

Background

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function

Phase 1

Not yet recruiting

Posted: 2024/12/16

Sponsor:

Italfarmaco

ID:NCT06736223

Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera

Phase 3

Recruiting

Posted: 2023/10/23

Sponsor:

Italfarmaco

ID:NCT06093672

Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy

Phase 3

Recruiting

Posted: 2023/07/06

Sponsor:

Italfarmaco

ID:NCT05933057

Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3)

Phase 1

Completed

Posted: 2023/05/16

Sponsor:

Italfarmaco

ID:NCT05860114

The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)

Phase 1

Completed

Posted: 2023/05/06

Sponsor:

Italfarmaco

ID:NCT05845567

FDA Approved Products

DUVYZAT

Manufacturer:Italfarmaco SPA

Route:ORAL

Strength:8.86 mg in 1 mL

Approved: 2024/03/29

NDC:11797-110

Singapore Approved Products

No Singapore products found for this drug

Related News

FDA Grants Fast Track Designation to Givinostat for Polycythemia Vera Treatment

22 days ago

The U.S. FDA has granted Fast Track designation to Italfarmaco's givinostat for treating polycythemia vera, a rare hematologic cancer with limited treatment options.

ITF Therapeutics Establishes New U.S. Hub for Rare Disease Innovation in Massachusetts

3 months ago

ITF Therapeutics has opened a new 10,000-square-foot U.S. headquarters in Concord, Massachusetts, designed to accommodate up to 40 team members and serve as a community engagement center for rare disease patients.

FDA Approves Five Groundbreaking Treatments for Ultra-Rare Diseases in Recent Months

3 months ago

The FDA has approved novel therapies for Duchenne Muscular Dystrophy, including ITF Therapeutics' Duvyzat (givinostat), which targets histone deacetylases to potentially slow muscle deterioration.

FDA Approvals in 2024: NASH Treatment, DMD Therapy, Novel Schizophrenia Drug, and Breast Cancer Advancement

6 months ago

The FDA approved Rezdiffra (resmetirom) as the first specific treatment for nonalcoholic steatohepatitis (NASH), addressing a critical unmet need for patients with liver damage.

Givinostat Shows Promise in Duchenne Muscular Dystrophy, Less Clear in Becker

6 months ago

A systematic review highlights givinostat's favorable functional and histological outcomes in Duchenne muscular dystrophy (DMD) patients.

Drug Development Updates

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