DUVYZAT (givinostat hydrochloride)
Duvyzat is a medication used for patients 6 years of age and older who have Duchenne muscular dystrophy (DMD). It helps patients with this progressive muscle-wasting condition by acting as a histone deacetylase inhibitor. This treatment is prescribed to manage the disease in both children and adults within the specified age group.
How DUVYZAT Works
Duvyzat works by inhibiting histone deacetylase enzymes. While the precise way this action helps patients with Duchenne muscular dystrophy is currently unknown, the drug is classified as a histone deacetylase inhibitor.
Details
- Status
- Prescription
- First Approved
- 2024-03-21
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- SUSPENSION
DUVYZAT Approval History
What DUVYZAT Treats
1 indicationsDUVYZAT is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Duchenne Muscular Dystrophy
DUVYZAT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in DUVYZAT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DUVYZAT treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DUVYZAT
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06769633 | DSC/14/2357/52 | Ph 2 | recruiting | Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DUVYZAT FDA Label Details
Indications & Usage
FDA Label (PDF)DUVYZAT is indicated for the treatment of Duchenne Muscular Dystrophy.
DUVYZAT Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for DUVYZAT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 4 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 9 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.