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A Phase 2 Open-label (Core Phase Plus Extension Phase) With 2 Cohorts Study to Assess the Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Than 6 Years Old

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Trial Profile

A Phase 2 Open-label (Core Phase Plus Extension Phase) With 2 Cohorts Study to Assess the Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Than 6 Years Old

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 27 Oct 2025

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At a glance

  • Drugs Givinostat (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Italfarmaco

Most Recent Events

  • 25 Aug 2025 According to an Italfarmaco media release, positive long-term safety and efficacy data for givinostat as a treatment for Duchenne muscular dystrophy (DMD) from this trial were published in published in Annals of Clinical and Translational Neurology
  • 17 Mar 2025 According to an ITF Therapeutics media release, data from this study presented at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference being held March 16-19, 2025, in Dallas, Texas.
  • 06 Mar 2025 According to the Italfarmaco Media Release, recruitment recently completed for the first cohort of 4- to 5-year-olds

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