Key Highlights

Risk & Performance

Pipeline Risk Assessment

Based on historical performance

High Risk

Score: 65/100

Failure Rate

16.2%

6 terminated/withdrawn out of 37 trials

Success Rate

80.0%

-6.5% vs industry average

Late-Stage Pipeline

14%

5 trials in Phase 3/4

Results Transparency

63%

15 of 24 completed trials have results

Key Signals

4 recruiting15 with results6 terminated

Enrollment Performance

Analytics

Phase 1

12(36.4%)

Phase 2

11(33.3%)

N/A

5(15.2%)

Phase 3

4(12.1%)

Phase 4

1(3.0%)

33Total

Phase 1(12)

Phase 2(11)

N/A(5)

Phase 3(4)

+1 more

Activity Timeline

Global Presence

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Clinical Trials (37)

Showing 20 of 37 trials

NCT06093672Phase 3Recruiting

Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera

Role: lead

NCT07376928Completed

Multicenter Prospective Real-world Observational Study to Evaluate the Effectiveness of Phlebotonics, as Conservative Therapy in a Cohort of Patients With Symptomatic Hemorrhoidal Disease (HD) of I, II or III Goligher Grade

Role: lead

NCT03373968Phase 2Recruiting

Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study

Role: lead

NCT06736223Phase 1Completed

Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function

Role: lead

NCT06769633Phase 2Recruiting

Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old

Role: lead

NCT05933057Phase 3Recruiting

Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy

Role: lead

NCT01761968Phase 2Active Not Recruiting

Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms

Role: lead

NCT05860114Phase 1Completed

Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3)

Role: lead

NCT05492318Phase 1Completed

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

Role: lead

NCT03238235Phase 2Completed

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

Role: lead

NCT05845567Phase 1Completed

The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)

Role: lead

NCT04821063Phase 1Completed

Placebo-Corrected Effects of Therapeutic Dose (100 mg) and Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval

Role: lead

NCT01761292Phase 1Completed

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

Role: lead

NCT06067256Phase 4Unknown

A Multicentre, Prospective, Open-label, Non-comparative Study

Role: lead

NCT00792740Phase 1Terminated

Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease

Role: lead

NCT02851797Phase 3Completed

Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy

Role: lead

NCT00792506Phase 2Terminated

Phase II Clinical Trial of ITF2357 In Patients With Relapsed/Refractory Multiple Myeloma

Role: lead

NCT00496431Phase 1Terminated

phII Study of an HDAC Inhibitor in Very High-risk Relapsed/Refractory Hodgkin's Lymphoma Patients

Role: lead

NCT00792831Phase 2Terminated

Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia

Role: lead

NCT01778205Completed

The Reus-Tarragona Birth Cohort Study of Early Development and Ageing.

Role: collaborator