Givinostat

Givinostat

Status

Phase |||

Therapeutic Approach

Improving Muscle Growth & Protection

Givinostat is an ‘HDAC inhibitor’ in that it blocks enzymes called histone deacetylases (HDACs), which are involved in turning genes ‘on’ and ‘off’ within cells and can reduce muscle regeneration in Duchenne. By inhibiting HDAC activity givionostat may help to activate muscle repair mechanisms to increase muscle fiber regeneration, reduce inflammation, and reduce fibrosis.

Status

A Phase 2 clinical trial to evaluate the safety and the potential of Givinostat as a treatment for Duchenne has been completed. A Phase 3 trial is ongoing in US, Canada, and Europe.

Sponsor

This program is sponsored by Italfarmaco SpA.

Related Studies

ONGOING
Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy
ONGOING
Givinostat in Patients with Becker Muscular Dystrophy
OPEN LABEL EXTENSION
Givinostat Long-term Safety and Tolerability Study

Media Library

APRIL 2020

Webinar: Italfarmaco Provides Givinostat Update

Italfarmaco joined PPMD for a webinar on April 22, 2020 to update the community about Italfarmaco’s development of Givinostat and the recent results of the futility analysis of the enrolling Phase 3 confirmatory study in Duchenne muscular dystrophy.
JUNE 2019

Italfarmaco Presents at the PPMD 2019 Annual Conference

MARCH 2019

Webinar: Italfarmaco Provides Givinostat Update

Italfarmaco joined PPMD for a webinar on March 27, 2019 to update the community about Italfarmaco's development of Givinostat and the enrolling Phase 3 confirmatory study in Duchenne muscular dystrophy.
JUNE 2018

Italfarmaco Presents at the PPMD 2018 Annual Conference

JAN 2018

Webinar: Italfarmaco Provides Givinostat Update

Italfarmaco joined PPMD for a webinar on January 24, 2018 to update the Duchenne community about Italfarmaco's development of Givinostat and the enrolling Phase 3 confirmatory study in Duchenne muscular dystrophy.
APRIL 2017

Webinar: Givinostat in Duchenne

Parent Project Muscular Dystrophy and Italfarmaco hosted a webinar on April 26, 2017 to discuss Italfarmaco's investigational drug Givinostat (a histone deacetylase (HDAC) inhibitor) and how it works in Duchenne. Our speakers presented a brief history of the development program, including pre-clinical results and preliminary results of the current Phase 2 clinical trial, study 43, which is ongoing in Italy, and answered questions from our community.

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