ITF announces updated long-term data for Duvyzat in DMD

29 August 2025

ITF Therapeutics, the US affiliate of privately-held Italian firm Italfarmaco, has announced publication of positive long-term safety and efficacy data for Duvyzat (givinostat) in Duchenne muscular dystrophy (DMD) from the company’s open-label extensions of its Phase II and Phase III (EPIDYS) trials. 

The results, published in Annals of Clinical and Translational Neurology, show that long-term treatment with givinostat, a novel histone deacetylase (HDAC) inhibitor, in combination with corticosteroids, delayed disease progression in ambulant patients aged six years and older with DMD.

Importantly, clinical benefit was observed across treatment groups receiving givinostat, with positive impact on key mobility functions such as rising from the floor, climbing stairs, and the ability to walk (ambulation). 

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