Drugs / Givinostat

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved · conditional EU (EMA) Duvyzat 2025-06-06 europa.eu
Approved US (FDA) DUVYZAT 2024-03-21 fda.gov

Trials 24 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT06736223 May → Aug 2025 Italfarmaco Completed No outcome recorded
Phase 1 NCT05845567 Mar → May 2022 Italfarmaco Completed No outcome recorded
Phase 1 NCT05860114 Mar → May 2022 Italfarmaco Completed No outcome recorded
Phase 1 NCT05492318 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
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 No outcome recorded
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
Phase 210 trials
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 No outcome recorded
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
Phase 2 NCT00792831 Feb 2008 → Apr 2009 chronic lymphocytic leukemia/small lymphocytic lymphoma Italfarmaco Terminated No outcome recorded
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
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT02851797 Comparator Jun 2017 → Feb 2022 Duchenne muscular dystrophy Italfarmaco Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 26 sources stand behind the page.

FieldValueCited text
Known as Givinostat ClinicalTrials.gov intervention name — accepted as the source's own label NCT05860114
14

NCT01557452

NCT05933057

NCT01901432

NCT01761292

NCT02851797

NCT01261624

NCT05845567

NCT03373968

NCT06093672

NCT01761968

NCT05492318

NCT03238235

NCT00928707

NCT06769633

Known as Duvyzat ChEMBL registry synonym — accepted as the source's own label CHEMBL1213492
Known as givinostat (ITF2357) givinostat (ITF2357)NCT01761968
2

Givinostat (ITF2357)NCT01901432

GIVINOSTAT (ITF2357)NCT00928707

Known as Givinostat Hydrochloride “Drug: Givinostat HydrochlorideNCT06769633
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
11

“givinostat (ITF2357)” NCT01761968

NCT00792467

NCT00570661

NCT00442182

NCT00792831

NCT00606307

NCT06736223

NCT00496431

NCT04821063

NCT00792506

NCT00792740

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