Givinostat Clinical Trials (2026): 15 Studies for Duchenne Muscular Dystrophy & Polycythemia Vera

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

Synced daily from ClinicalTrials.gov via AACT. Last sync: .

15 Givinostat clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 9 indications (including Duchenne Muscular Dystrophy & Polycythemia Vera) and 1,086 total planned enrollment. 3 Phase 3 Givinostat trials and 5 Phase 2 are listed. 4 Givinostat clinical trials are actively recruiting at 15 U.S. sites across 13 states. Most recent activity: NCT06769633 (Dec 2029).

Where to Participate: All Givinostat Trial Sites in the U.S. (15 sites across 13 states)

Every actively recruiting Givinostattrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.

StateFacilityCityTrialMap
CAEmad Ibrahim, MD, IncRedlands92373NCT06093672Map
COUS Oncology IncEnglewood80113NCT06093672Map
GAMD Rare Disease Research, LLCAtlanta30318NCT03373968Map
IAUniversity of Iowa Children's HospitalIowa City52242NCT03373968Map
MDAmerican Oncology Partners of Maryland, PABethesda20852NCT06093672Map
NYIcahn School of Medicine at Mount SinaiNew York10029NCT06093672Map
NCUniversity of North Carolina at Chapel HillChapel Hill27599NCT06093672Map
OHThe Cleveland Clinic FoundationCleveland44195NCT06093672Map
OROncology Associates of Oregon, P.C.Eugene97401NCT06093672Map
TXMD Anderson Cancer CenterHouston77030NCT06093672Map
TXTexas Oncology (Webster) - USORHouston77089NCT06093672Map
TXTexas Oncology-Denison Cancer CenterSherman75090NCT06093672Map
UTUniversity of Utah - Huntsman Cancer Institute - PPDSSalt Lake City84112NCT06093672Map
VAThe James Cancer Hospital and Solove Research InstituteRoanoke43210NCT06093672Map
WAVA Puget Sound Health Care System - NAVREF - PPDSSeattle98108-1532NCT06093672Map

Givinostat clinical trials at a glance: phase × recruitment status

Phaserecruitingactive not recruitingcompletedterminatedTotal
P133
P1/P222
P211215
P2/P311
P3213
N/A11

Recruiting Givinostat clinical trials (4)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT06769633Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years OldP2Duchenne Muscular Dystrophy18Jan 2025
NCT03373968Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability StudyP2/P3Duchenne Muscular Dystrophy206Oct 2017
NCT05933057ULYSSESEfficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular DystrophyP3Duchenne Muscular Dystrophy138Feb 2024
NCT06093672GIV-IN-PVStudy on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia VeraP3Polycythemia Vera220Mar 2024

Givinostat clinical trials by indication

Duchenne Muscular Dystrophy (4)

NCTAcronymPhaseStatusTitle
NCT06769633P2recruitingPharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old
NCT03373968P2/P3recruitingGivinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study
NCT05933057ULYSSESP3recruitingEfficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy
NCT02851797P3completedClinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy

Polycythemia Vera (3)

NCTAcronymPhaseStatusTitle
NCT06093672GIV-IN-PVP3recruitingStudy on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
NCT01901432P1/P2completedA Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera
NCT00928707PVP2completedPhase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera

Drug Drug Interaction (2)

NCTAcronymPhaseStatusTitle
NCT05860114P1completedGivinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3)
NCT05845567P1completedThe Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)

Drug-Drug Interaction (1)

NCTAcronymPhaseStatusTitle
NCT05492318P1completedPerpetrator DDI Potential of Givinostat as Inhibitor and Inducer of CYP3A and P-gp Activity

Becker Muscular Dystrophy (1)

NCTAcronymPhaseStatusTitle
NCT03238235P2completedClinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy

Duchenne Muscular Dystrophy (DMD) (1)

NCTAcronymPhaseStatusTitle
NCT01761292P1/P2completedA Study to Assess Safety/Tolerability, pk, Effects on Histology, Clinical Parameters of Givinostat in Children With DMD

Chronic Myeloproliferative Neoplasms (1)

NCTAcronymPhaseStatusTitle
NCT01761968P2active not recruitingLong-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms

Juvenile Idiopathic Arthritis (1)

NCTAcronymPhaseStatusTitle
NCT01557452N/AterminatedOpen-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis

Polyarticular Course Juvenile Idiopathic Arthritis (1)

NCTAcronymPhaseStatusTitle
NCT01261624P2terminatedEfficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic Arthritis

Givinostat pivotal trial highlights (Phase 2/3/4)

Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
ULYSSESNCT05933057P3recruitingDuchenne Muscular Dystrophy138PMID 23552722
GIV-IN-PVNCT06093672P3recruitingPolycythemia Vera220
PVNCT00928707P2completedPolycythemia Vera45

Terminated and withdrawn Givinostat trials (2)

Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.

All Givinostat trials (15)

Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.

NCT IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT06769633Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years OldP2recruiting18ItalfarmacoJan 2025
NCT03373968Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability StudyP2/P3recruiting206ItalfarmacoOct 2017
NCT05933057ULYSSESEfficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular DystrophyP3recruiting138ItalfarmacoFeb 2024
NCT01761968Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative NeoplasmsP2active not recruiting90ItalfarmacoMar 2013
NCT06093672GIV-IN-PVStudy on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia VeraP3recruiting220ItalfarmacoMar 2024
NCT05492318Perpetrator DDI Potential of Givinostat as Inhibitor and Inducer of CYP3A and P-gp ActivityP1completed26ItalfarmacoMar 2022
NCT05860114Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3)P1completed8ItalfarmacoMar 2022
NCT05845567The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)P1completed20ItalfarmacoMar 2022
NCT02851797Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular DystrophyP3completed179ItalfarmacoJun 2017
NCT03238235Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular DystrophyP2completed51ItalfarmacoJan 2018
NCT01761292A Study to Assess Safety/Tolerability, pk, Effects on Histology, Clinical Parameters of Givinostat in Children With DMDP1/P2completed20ItalfarmacoApr 2013
NCT01901432A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia VeraP1/P2completed48ItalfarmacoOct 2013
NCT01557452Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic ArthritisN/Aterminated1ItalfarmacoDec 2011
NCT01261624Efficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic ArthritisP2terminated16ItalfarmacoOct 2010
NCT00928707PVPhase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia VeraP2completed45ItalfarmacoJun 2009

Givinostat clinical trials: frequently asked questions

How many Givinostat clinical trials are there?
15 Givinostat clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 4 are actively recruiting participants. 8 are marked completed.
Are Givinostat clinical trials recruiting in 2026?
Yes — 4 Givinostat trials are actively recruiting in 2026, with 15 U.S. sites across 13 states. See the recruiting trials and the per-state site list further down this page.
What conditions is Givinostat being studied for?
Givinostat is being studied for Duchenne Muscular Dystrophy, Polycythemia Vera, Drug Drug Interaction, Becker Muscular Dystrophy, Heathy Volunteer and 5 more. The trials are grouped by indication on this page.
What phase is Givinostat in?
Givinostat clinical trials span 3 Phase 3, 5 Phase 2, 3 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
Who sponsors Givinostat clinical trials?
The lead sponsor across the most Givinostat trials is Italfarmaco. Each trial row links to the full study detail page including sponsor information.

Sources and methodology

Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Givinostatas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.

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