NDAORALSUSPENSIONPriority Review
Approved
Mar 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
6/8 — Strong
Priority Review
DUVYZAT (givinostat) by Italfarmaco Research is histone deacetylase inhibitors [moa]. Approved for duchenne muscular dystrophy. First approved in 2024.
Drug data last refreshed 19h ago
Mechanism of Action
Histone Deacetylase Inhibitors
Pharmacologic Class:
Histone Deacetylase Inhibitor
Indications (1)
Clinical Trials (3)
Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old
Started Jan 2025
18 enrolled
Duchenne Muscular Dystrophy
Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy
Started Feb 2024
138 enrolled
Duchenne Muscular Dystrophy
Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy
Started Jun 2017
179 enrolled
Duchenne Muscular Dystrophy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.