Introducing Duvyzat®
Adverse event reporting information can be found at the bottom of this page.
Click HERE for prescribing information.
What is Duvyzat®?
Duvyzat® is a convenient oral therapy for patients with Duchenne muscular dystrophy (DMD) and is a liquid suspension administered twice daily using the provided graduated oral syringe.1
Who is Duvyzat® indicated for?
Duvyzat® is indicated for the treatment of DMD in patients 6 years of age and older.1
Duvyzat® is a DMD mutation-independent therapy.2
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Real patient currently on Duvyzat® treatment. Photograph for illustrative purposes only, individual results may vary
Duvyzat® (givinostat) is now recommended by NICE
What could Duvyzat® mean for your patients?
PRESERVES
Muscle Function*3-6
DELAYS
Disease Progression*3,7
Real patient currently on Duvyzat® treatment. Photograph for illustrative purposes only, individual results may vary
*compared to baseline
- Duvyzat® has been shown to counteract DMD disease progression by reducing muscle fibre damage, chronic muscular inflammation, fibrosis, fat deposition, and promoting muscular regeneration.1,3-9
How does Duvyzat® work?
Watch these short videos on how Duvyzat® targets key DMD pathological events
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In human cells, DNA is wrapped around histone proteins, which bind DNA tightly or loosely depending on their acetylation state. When histones are acetylated, DNA is “open” and accessible for gene expression. When histones are deacetylated, DNA is “closed” and inaccessible for gene expression.
Histone deacetylases (HDACs) are enzymes that deacetylate histones, inhibiting gene expression. These enzymes are pathologically upregulated in the muscle cells of patients with DMD.
Duvyzat® is an HDAC inhibitor that targets the balance between histone acetylation and deacetylation, restoring the expression of genes needed for moderating inflammation, and enhancing muscle maintenance and repair. Duvyzat® HDAC inhibition is independent of the specific dystrophin gene mutation causing the disease.4
Read the article by A. Aartsma-Rus on how Duvyzat® works
Histone deacetylase inhibition with givinostat: a multi-targeted mode of action with the potential to halt the pathological cascade of Duchenne muscular dystrophy. Article by A. Aartsma-Rus
Clinical development
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.
Adverse events should also be reported to ITF Pharma Ltd Medical Information on: 0800 098 4040 or UK.Medical.Information@italfarmacogroup.com
Product Quality Complaints should also be reported to ITF Pharma Ltd Medical Information on: 0800 098 4040 or UK.Medical.Information@italfarmacogroup.com
References
- Duvyzat Summary of Product Characteristics, MHRA, https://www.medicines.org.uk/emc/product/100605/smpc
- Duvyzat Summary of Product Characteristics. EMA, June 2025. https://www.ema.europa.eu/en/documents/product-information/duvyzat-epar-product-information_en.pdf
- Mercuri E, Vilchez JJ, Boespflug-Tanguy O, et al. Safety and efficacy of givinostat in boys with Duchenne muscular dystrophy (EPIDYS): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2024; 23: 393-403.
- Aartsma-Rus A. Histone deacetylase inhibition with givinostat: a multi-targeted mode of action with the potential to halt the pathological cascade of Duchenne muscular dystrophy. Front Cell Dev Biol. 2025;12:1514898.
- Licandro SA, Crippa L, Pomarico R, et al. The pan HDAC inhibitor Givinostat improves muscle function and histological parameters in two Duchenne muscular dystrophy murine models expressing different haplotypes of the LTBP4 gene. Skelet Muscle. 2021;11(1):19.
- Consalvi S, Mozzetta C, Bettica P, et al. Preclinical studies in the mdx mouse model of duchenne muscular dystrophy with the histone deacetylase inhibitor givinostat. Mol Med. 2013;19(1):79-87.
- Bettica P, Petrini S, D’Oria V, et al. Histological e¦ects of givinostat in boys with Duchenne muscular dystrophy. Neuromuscul Disord. 2016;26(10):643-649.
- Giovarelli M, Zecchini S, Catarinella G, et al. Givinostat as metabolic enhancer reverting mitochondrial biogenesis deficit in Duchenne Muscular Dystrophy. Pharmacol Res. 2021;170:105751.
- Leoni F, Fossati G, Lewis EC, et al. The Histone Deacetylase Inhibitor ITF2357 Reduces Production of Pro-Inflammatory Cytokines In Vitro
and Systemic Inflammation In Vivo. Mol Med. 2005;11(1-12):1-15.
