Publications
Givinostat Clinical Trials in Duchenne Muscular Dystrophy
The following resources are publications on clinical trials sponsored by ITF Therapeutics/Italfarmaco on givinostat for its approved US indication. Please refer to the Duvyzat Prescribing Information for more information. To access the individual publications, click on the drop-down arrow(s) below. For a comprehensive list of publications, please refer to Pubmed.
Phase 2 Study
Bettica P, Petrini S, D’Oria V, et al. Histological effects of givinostat in boys with Duchenne muscular dystrophy. Neuromuscul Disord. 2016;26(10):643-649.
Phase 3 Study
Mercuri E, Vilchez JJ, Boespflug-Tanguy O, et al. Safety and efficacy of givinostat in boys with Duchenne muscular dystrophy (EPIDYS): a multicentre, randomized, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2024;23(4):393-403.
Open-label Extension Study
McDonald CM, Guglieri M, Vucinic D, et al. Long-term evaluation of givinostat in Duchenne muscular dystrophy, and natural history comparisons. Ann Clin Transl Neurol. 2025;12(11):2335-2348.