Givinostat

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

Title	Posted	Study ID	Phase	Status	Sponsor
Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function	2024/12/16	NCT06736223	Phase 1	Recruiting	Italfarmaco
Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera	2023/10/23	NCT06093672	Phase 3	Recruiting	Italfarmaco
Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy	2023/07/06	NCT05933057	Phase 3	Recruiting	Italfarmaco
Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3)	2023/05/16	NCT05860114	Phase 1	Completed	Italfarmaco
The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)	2023/05/06	NCT05845567	Phase 1	Completed	Italfarmaco
Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study	2017/12/14	NCT03373968	Phase 2	Active, not recruiting	Italfarmaco
Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy	2017/08/03	NCT03238235	Phase 2	Completed	Italfarmaco
Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy	2016/08/02	NCT02851797	Phase 3	Completed	Italfarmaco
A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera	2013/07/17	NCT01901432	Phase 1	Completed	Italfarmaco
Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms	2013/01/07	NCT01761968	Phase 2	Active, not recruiting	Italfarmaco

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
DUVYZAT	Italfarmaco SPA	11797-110	ORAL	8.86 mg in 1 mL	3/29/2024

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

Givinostat Shows Promise for Duchenne Muscular Dystrophy as Families Push for Broader Access

2 months ago

Givinostat, a histone deacetylase inhibitor, has received conditional approval in Europe for treating Duchenne Muscular Dystrophy (DMD), offering hope to slow disease progression in affected boys.

FDA Grants Fast Track Designation to Givinostat for Polycythemia Vera Treatment

2 months 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

4 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