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While the exact mechanism is unknown,

DUVYZAT targets the key pathologic process of HDAC overactivity1,2

As a novel HDAC inhibitor, DUVYZAT is thought to work by targeting HDAC overactivity, leading to increased muscle fiber repair and regeneration, decreased inflammation, and reduced adipogenesis and fibrogenesis.2,3

3D Duvy molecule

Mechanism of action:

Scroll to see how DUVYZAT may target this key pathologic process in DMD1,2

DMD, Duchenne muscular dystrophy; HDAC, histone deacetylase.

The role of HDAC in normal muscle repair3

HDACs play a key role in maintaining and repairing muscle tissue by modifying proteins that regulate muscle fiber repair pathways.

HDAC overactivity in DMD2-4

In DMD, HDAC is overactive.

Increased HDAC activity, in combination with the structural instability of dystrophin-deficient muscle cells, disrupts the process of normal muscle repair and accelerates the deterioration of tissue.

HDAC upregulation results in3,4:

  • Activation of chronic inflammatory pathways
  • Impairment of muscle repair
  • Fibrogenesis and adipogenesis
  • Muscular atrophy

How DUVYZAT works2,4

DUVYZAT is a pan-HDAC inhibitor.

While its exact mechanism is unknown, DUVYZAT targets HDAC overactivity.

The DUVYZAT effect

Inhibiting HDAC overactivity with DUVYZAT may lead to increased muscle fiber repair and regeneration, decreased inflammation, and reduced adipogenesis and fibrogenesis.5

As the only HDAC inhibitor indicated to treat DMD, DUVYZAT offers a unique, mutation-agnostic approach to protecting muscle function.1,3,4

Explore the efficacy and safety results from the pivotal clinical trial.

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References: 1. DUVYZAT. Prescribing information. ITF Therapeutics; 2024. 2. Consalvi S, Saccone V, Giordani L, Minetti G, Mozzetta C, Puri PL. Histone deacetylase inhibitors in the treatment of muscular dystrophies: epigenetic drugs for genetic diseases. Mol Med. 2011;17(5-6):457-465. 3. Sandonà M, Cavioli G, Renzini A, et al. Histone deacetylases: molecular mechanisms and therapeutic implications for muscular dystrophies. Int J Mol Sci. 2023;24(5):4306. 4. Mercuri E, Vilchez JJ, Boespflug-Tanguy O, et al; EPIDYS Study Group. 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(4):393-403. 5. Consalvi S, Mozzetta C, Bellica 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.

Indication and Important Safety Information

DUVYZAT is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.

Important Safety Information

Warnings and precautions

  • Hematological Changes: DUVYZAT can cause dose-related thrombocytopenia and other signs of myelosuppression, including anemia and neutropenia. Monitor platelets; dosage adjustment or discontinuation may be needed.
  • Increased Triglycerides: An increase in triglycerides can occur; dosage modification may be needed. Discontinuation may be needed.
  • Gastrointestinal Disturbances: Adjust dosage if moderate or severe diarrhea occurs. Antiemetics or antidiarrheal medications may be considered during treatment with DUVYZAT. Discontinue DUVYZAT if the symptoms persist.
  • QTc Prolongation: Avoid use of DUVYZAT in patients who are at an increased risk for ventricular arrhythmias.

Indication

DUVYZAT is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.

Important Safety Information

Warnings and precautions

  • Hematological Changes: DUVYZAT can cause dose-related thrombocytopenia and other signs of myelosuppression, including anemia and neutropenia. Monitor platelets; dosage adjustment or discontinuation may be needed.
  • Increased Triglycerides: An increase in triglycerides can occur; dosage modification may be needed. Discontinuation may be needed.
  • Gastrointestinal Disturbances: Adjust dosage if moderate or severe diarrhea occurs. Antiemetics or antidiarrheal medications may be considered during treatment with DUVYZAT. Discontinue DUVYZAT if the symptoms persist.
  • QTc Prolongation: Avoid use of DUVYZAT in patients who are at an increased risk for ventricular arrhythmias.

Recommended Evaluation and Testing Before Initiation of DUVYZAT:

Obtain and evaluate baseline platelet counts and triglycerides prior to initiation of DUVYZAT. Do not initiate DUVYZAT in patients with a platelet count less than 150 x 109/L. Monitor platelet counts and triglycerides as recommended during treatment to determine if dosage modifications are needed.

In addition, in patients with underlying cardiac disease or taking concomitant medications that cause QT prolongation, obtain ECGs when initiating treatment with DUVYZAT, during concomitant use, and as clinically indicated.

Most Common Adverse Reactions:

Most common adverse reactions (≥10% in DUVYZAT-treated patients) are diarrhea, abdominal pain, thrombocytopenia, nausea/vomiting, hypertriglyceridemia, and pyrexia.

To report SUSPECTED ADVERSE REACTIONS, contact ITF Therapeutics LLC at 1-833-582-4312 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Medication Guide.