NDAORALSUSPENSIONPriority Review
Approved
Mar 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
5/8 — Partial
Priority Review
DUVYZAT (givinostat) by Italfarmaco Research is histone deacetylase inhibitors [moa]. First approved in 2024.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DUVYZAT (givinostat) is an oral histone deacetylase (HDAC) inhibitor approved in March 2024 for treatment of a rare genetic disorder. It works by inhibiting HDAC enzymes, which regulate gene expression and protein modifications. The drug is formulated as an oral suspension for easier administration in pediatric and specialized populations.
Growth10.4 years to LOE
As a newly approved 2024 product in growth phase, the commercial team is likely expanding with early adoption initiatives and building market infrastructure.
Mechanism of Action
Histone Deacetylase Inhibitors
Pharmacologic Class:
Histone Deacetylase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
Career Relevance
Working on DUVYZAT offers early-stage growth opportunity in a newly approved rare disease product with a small but focused patient population. Roles are concentrated in commercial and market access functions as the company builds awareness and adoption in a specialized indication.
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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.