Product Description
Mechanisms of Action: HDAC Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Fast Track - Polycythemia Vera *
Approval Status: Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Italfarmaco
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Belgium, Bulgaria, Canada, Croatia, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Serbia, Spain, United Kingdom, United States
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Muscular Dystrophy, Duchenne|Polycythemia Vera
Phase 2: Oncology Unspecified
Phase 1: Other
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06736223 |
ITF/2357/60 | P1 |
Recruiting |
Other |
2025-08-01 |
50% |
2025-06-13 |
Primary Endpoints|Start Date|Treatments|Trial Status |
2024-512413-40-00 |
DSC/11/2357/44 | P2 |
Active, not recruiting |
Oncology Unspecified |
2029-09-30 |
2025-05-02 |
Treatments |
|
NCT05933057 |
ULYSSES | P3 |
Recruiting |
Muscular Dystrophy, Duchenne |
2028-02-01 |
41% |
2024-02-23 |
Primary Endpoints |
NCT06093672 |
GIV-IN-PV | P3 |
Recruiting |
Polycythemia Vera |
2026-07-01 |
13% |
2025-06-24 |
|
2023-503521-19-00 |
DSC/14/2357/50 | P3 |
Recruiting |
Muscular Dystrophy, Duchenne |
2027-12-30 |
2025-05-02 |
Treatments |
|
2023-504520-26-00 |
DSC/14/2357/51 | P3 |
Recruiting |
Muscular Dystrophy, Duchenne |
2027-12-03 |
2025-05-02 |
Treatments |
|
2022-502276-23-00 |
DSC/08/2357/32 | P3 |
Recruiting |
Polycythemia Vera |
2031-09-30 |
13% |
2025-05-02 |
Treatments |
NCT03373968 |
DSC/14/2357/51 | P3 |
Active, not recruiting |
Muscular Dystrophy, Duchenne |
2029-12-01 |
59% |
2025-05-01 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06769633 |
DSC/14/2357/52 | P2 |
Recruiting |
Muscular Dystrophy, Duchenne |
2029-12-01 |
50% |
2025-01-25 |
Primary Endpoints|Start Date|Treatments|Trial Status |
2024-511823-32-00 |
DSC/14/2357/52 | P2 |
Recruiting |
Muscular Dystrophy, Duchenne |
2028-12-31 |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
10/07/2025 |
News Article |
New Data Presented on Givinostat for Treatment of Duchenne Muscular Dystrophy at 2025 World Muscle Society Congress |
|
09/26/2025 |
News Article |
New Data Presented on Givinostat for Treatment of Duchenne Muscular Dystrophy at 2025 Neuromuscular Study Group Annual Scientific Meeting |
|
09/23/2025 |
News Article |
Santhera Announces Half Year 2025 Financial Results and Provides Corporate Update |
|
09/16/2025 |
News Article |
Italfarmaco Announces Exclusive Distribution Agreement with Multicare Pharma for DMD Treatment Givinostat in Brazil |