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 5h 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 by the FDA. It represents a novel mechanism for treating rare genetic and hematologic disorders through epigenetic modulation. The drug is administered as an oral suspension, offering improved accessibility compared to IV formulations.
Growth13.6 years to LOE
Early-stage product in growth phase with 13.6 years of patent protection; brand team expansion likely underway to establish market presence in rare disease segment.
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
DUVYZAT represents a high-visibility opportunity within Italfarmaco's rare disease portfolio and the broader HDAC inhibitor space. Career professionals joining this brand will experience direct exposure to product launch dynamics, rare disease market development, and the establishment of a novel mechanism franchise with extended patent protection.
Worked on DUVYZAT at Italfarmaco Research? Share your interview experience or compensation data (+7 days Pro)
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.