Drugs / Givinostat
Givinostat
also known as
ITF2357 · givinostat (ITF2357) · Duvyzat · Givinostat Hydrochloride · ITF-2357 HYDROCHLORIDE MONOHYDRATE · ITF2357 HYDROCHLORIDE
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed DMD-related muscular dystrophy 1 milestone | |||||
| Filed | EU (EMA) | — | DMD-related muscular dystrophy | 2024-06-28 | “the Marketing Authorization Application (MAA) for Givinostat has been submitted to the European Medicine Agency (EMA).” italfarmaco.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved · conditional | EU (EMA) | Duvyzat | — | 2025-06-06 | europa.eu ↗ |
| Approved | US (FDA) | DUVYZAT | — | 2024-03-21 | fda.gov ↗ |
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 1 met primary | ||||||
| Phase 1 | NCT06736223 | May → Aug 2025 | — | Italfarmaco | Completed | No outcome recorded |
| Phase 1 | NCT05845567 | Mar → May 2022 | — | Italfarmaco | Completed | Met primary |
| Phase 1 | NCT05492318 | Mar → May 2022 | — | Italfarmaco | Completed | No outcome recorded |
| Phase 1 | NCT05860114 | Mar → May 2022 | — | Italfarmaco | Completed | No outcome recorded |
| Phase 1 | NCT04821063 | Apr → Jun 2021 | Duchenne muscular dystrophy, acquired polycythemia vera | Italfarmaco | Completed | No outcome recorded |
| Phase 1/25 trials · 1 met primary | ||||||
| Phase 1/2 | NCT01901432 | Oct 2013 → Jun 2017 | acquired polycythemia vera | Italfarmaco | Completed | No outcome recorded |
| Phase 1/2 | NCT01761292 | Apr 2013 → Dec 2014 | Duchenne muscular dystrophy | Italfarmaco | Completed | Met primary |
| Phase 1/2 | NCT00792467 | Feb 2008 → Jul 2010 | Hodgkins lymphoma | Italfarmaco | Completed | No outcome recorded |
| Phase 1/2 | NCT00792740 | Oct 2007 → Dec 2008 | Crohn disease | Italfarmaco | Terminated | No outcome recorded |
| Phase 1/2 | NCT00496431 | May 2007 → Mar 2009 | Hodgkins lymphoma | Italfarmaco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 210 trials · 1 missed | ||||||
| Phase 2 | NCT06769633 | Jan 2025 → Dec 2029 expected | Duchenne muscular dystrophy | Italfarmaco | Recruiting | No outcome recorded |
| Phase 2 | NCT03238235 | Jan 2018 → Mar 2021 | Becker muscular dystrophy | Italfarmaco | Completed | Missed primary |
| Phase 2 | NCT01761968 | Mar 2013 → Dec 2026 expected | myeloproliferative neoplasm | Italfarmaco | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01261624 | Oct 2010 → Jun 2012 | polyarticular juvenile idiopathic arthritis | Italfarmaco | Terminated | No outcome recorded |
| Phase 2 | NCT00928707 | Jun 2009 → Jul 2011 | acquired polycythemia vera | Italfarmaco | Completed | No outcome recorded |
| Phase 2 | NCT00792506 | Oct 2008 → Jan 2010 | plasma cell myeloma | Italfarmaco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00792831 | Feb 2008 → Apr 2009 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Italfarmaco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00606307 | Dec 2007 → Dec 2008 | myeloproliferative neoplasm | Italfarmaco | Completed | No outcome recorded |
| Phase 2 | NCT00570661 | Sep 2006 → Aug 2008 | systemic-onset juvenile idiopathic arthritis | Italfarmaco | Completed | No outcome recorded |
| Phase 2 | NCT00442182 | Sep 2006 → ? | Schnitzler syndrome, TNF receptor 1-associated periodic fever syndrome | Radboud University Medical Center | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03373968 | Oct 2017 → Dec 2029 expected | Duchenne muscular dystrophy | Italfarmaco | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06093672 | Mar 2024 → Jul 2026 overdue | acquired polycythemia vera | Italfarmaco | Recruiting | No outcome recorded |
| Phase 3 | NCT05933057 | Feb 2024 → Feb 2028 expected | Duchenne muscular dystrophy | Italfarmaco | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01557452 | Dec 2011 → Jan 2014 | juvenile idiopathic arthritis | Italfarmaco | Terminated | No outcome recorded Stop: Business |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT02851797 Comparator | Jun 2017 → Feb 2022 | Duchenne muscular dystrophy | Italfarmaco | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-09-30 | Italfarmaco | Results Italfarmaco Presents New Givinostat Clinical Data Supporting Preservation of Upper Limb Function in Duchenne Muscular Dystrophy Patients at the 2026 World Muscle Society Congress italfarmaco.com ↗ |
| 2026-06-10 | Italfarmaco | Regulatory Italfarmaco Announces Health Canada Acceptance and Priority Review of New Drug Submission for Givinostat as a Duchenne Muscular Dystrophy Treatment italfarmaco.com ↗
Health Canada has granted givinostat Priority Review status, a designation reserved for drugs that may provide a significant improvement in the benefit-risk profile over existing therapies. |
| 2025-10-07 | Italfarmaco | Results New Data Presented on Givinostat for Treatment of Duchenne Muscular Dystrophy at 2025 World Muscle Society Congress italfarmaco.com ↗
Long-term treatment with givinostat in boys with Duchenne muscular dystrophy continues to show a favourable safety and tolerability profile |
| 2025-07-11 | Italfarmaco | Results Italfarmaco Presents New Cardiac Data for Givinostat at 16th European Paediatric Neurology Society (EPNS) Congress italfarmaco.com ↗ |
| 2025-06-06 | Italfarmaco | Regulatory European Commission Approves Duvyzat for the Treatment of Duchenne Muscular Dystrophy italfarmaco.com ↗
Italfarmaco S.p.A. announced today that the European Commission (EC) has granted conditional marketing authorisation for Duvyzat® (givinostat), a novel histone deacetylase (HDAC) inhibitor . |
| 2025-04-28 | Italfarmaco | Regulatory CHMP recommends EU approval for Duvyzat to treat Duchenne muscular dystrophy italfarmaco.com ↗
CHMP recommends EU approval for Duvyzat to treat Duchenne muscular dystrophy |
| 2020-10-12 | Italfarmaco | Regulatory Italfarmaco Receives FDA Rare Pediatric Disease Designation for Givinostat in Duchenne Muscular Dystrophy… italfarmaco.com ↗
The U.S. Food and Drug Administration (FDA) granted a Rare Pediatric Disease designation to Givinostat for the treatment of DMD, which allows an expedited review process for new treatment modalities. |
All press releases naming this drug 7 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | givinostat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02851797 ↗ |
| Known as | Duvyzat | ChEMBL registry synonym — accepted as the source's own label CHEMBL1213492 ↗ |
| Known as | givinostat (ITF2357) | “givinostat (ITF2357)” NCT01761968 ↗ |
| Known as | Givinostat Hydrochloride | “Drug: Givinostat Hydrochloride” NCT06769633 ↗ |
| Known as | ITF-2357 HYDROCHLORIDE MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1213492 ↗ |
| Known as | ITF2357 | “Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera” NCT00928707 ↗ |
| Known as | ITF2357 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1213492 ↗ |
| Action | Inhibit | “histone deacetylase inhibitor (ITF2357)” NCT00496431 ↗ |
| Modality | Small molecule | — CHEMBL1213492 ↗ |
| Route | Oral | “ITF2357 is an orally active histon deacetylase inhibitor” NCT00442182 ↗ |