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GIVINOSTAT HYDROCHLORIDE
At a glance
| Generic name | GIVINOSTAT HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2024 |
Approved indications
Common side effects
Key clinical trials
- Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera (PHASE3)
- Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function (PHASE1)
- Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old (PHASE2)
- Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy (PHASE3)
- Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms (PHASE2)
- Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3) (PHASE1)
- Perpetrator DDI Potential of Givinostat as Inhibitor and Inducer of CYP3A and P-gp Activity (PHASE1)
- Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- GIVINOSTAT HYDROCHLORIDE CI brief — competitive landscape report
- GIVINOSTAT HYDROCHLORIDE updates RSS · CI watch RSS