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Duvyzat (GIVINOSTAT)
Duvyzat works by blocking enzymes that compact chromatin and silence genes.
Duvyzat (givinostat) is a small molecule Histone Deacetylase Inhibitor (HDACi) developed by Italfarmaco Spa. It is approved by the FDA for the treatment of Duchenne muscular dystrophy (DMD). Duvyzat works by inhibiting histone deacetylases, which are enzymes that remove acetyl groups from histones, leading to chromatin compaction and gene silencing. The drug is patented and has not yet reached generic status. Key safety considerations include its short half-life of 6 hours.
At a glance
| Generic name | GIVINOSTAT |
|---|---|
| Sponsor | Italfarmaco Spa |
| Drug class | Histone Deacetylase Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Rare Disease |
| Phase | FDA-approved |
| First approval | 2024 |
Mechanism of action
DUVYZAT is a histone deacetylase inhibitor. The precise mechanism by which DUVYZAT exerts its effect in patients with DMD is unknown.
Approved indications
- Duchenne muscular dystrophy (DMD)
Common side effects
- Diarrhea
- Abdominal pain
- Thrombocytopenia
- Nausea/Vomiting
- Hypertriglyceridemia
- Pyrexia
- Myalgia
- Rash
- Arthralgia
- Fatigue
- Constipation
- Decreased appetite
Drug interactions
- CYP3A4 sensitive substrates
- OCT2 sensitive substrates
- Drugs that prolong the QTc interval
Key clinical trials
- Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera (PHASE3)
- Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study (PHASE2,PHASE3)
- Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function (PHASE1)
- A Study Evaluating the Real-World Experience of Givinostat in Patients With Duchenne Muscular Dystrophy
- Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old (PHASE2)
- Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy (PHASE3)
- DMD Voice: Qualitative Interviews With Patients and Caregivers
- Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |