Friday, July 10, 2026

Drug profile · INN

givinostat hydrochloride

givinostat hydrochloride (DUVYZAT) is a histone deacetylase inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — givinostat hydrochloride
US status
approved
Class
Route
ORAL
Patents
0
Programs
1
Data quality
0.84

Quick answer

givinostat hydrochloride (DUVYZAT) is a histone deacetylase inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN givinostat hydrochloride
Brand DUVYZAT
Mechanism Histone deacetylase inhibitor
Target Histone deacetylase
Route ORAL
Formulation SUSPENSION

Mechanism of action

Histone deacetylase inhibitor

Primary target: Histone deacetylase

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. DSC/14/2357/50 Phase 3 · ITALFARMACO S.P.A · Duchenne muscular dystrophy (DMD)

Related & competitor drugs

  1. romidepsin Antineoplastic and immunomodulating agents (L01)
  2. belinostat Histone deacetylase inhibitor
  3. panobinostat lactate Histone deacetylase inhibitor
  4. vorinostat Histone deacetylase 3 inhibitor
  5. abexinostat Histone deacetylase inhibitor

Frequently asked questions

What is givinostat hydrochloride?

givinostat hydrochloride (DUVYZAT) is a histone deacetylase inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for givinostat hydrochloride?

DUVYZAT is a marketed brand name for givinostat hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of givinostat hydrochloride?

givinostat hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.