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Details:
Duvyzat (givinostat) is a novel histone deacetylase (HDAC) inhibitor, which is being evaluated for the treatment of patients 6 years or older with Duchenne muscular dystrophy.
Lead Product(s): Givinostat
Therapeutic Area: Genetic Disease Product Name: Duvyzat
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2024
Details:
ITF2357 (givinostat) is an HDAC Inhibitor small molecule drug, currently being investigated as an oral suspension for the treatment of Duchenne Muscular Dystrophy.
Lead Product(s): Givinostat
Therapeutic Area: Genetic Disease Product Name: ITF2357
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2023
Details:
ITF2357 (givinostat) is an investigational drug act as a inhibits histone deacetylases (HDACs), which is investigated for the treatment of Duchenne Muscular Dystrophy.
Lead Product(s): Givinostat
Therapeutic Area: Genetic Disease Product Name: ITF2357
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Syneos Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2023
Details:
The study compared ITF2357 (givinostat) to placebo and met the primary endpoint (change from baseline in the time to climb 4 stairs) following 18 months of treatment in the target population1 with key secondary endpoints consistent with the functional primary endpoint.
Lead Product(s): Givinostat
Therapeutic Area: Genetic Disease Product Name: ITF2357
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2022
Details:
Italfarmaco provided evidence which continues to show a delay in disease progression in DMD boys aged 7-11 years at treatment start, supported by data on the 7-year follow-up period from the long-term study with Givinostat in addition to steroid treatment.
Lead Product(s): Givinostat
Therapeutic Area: Genetic Disease Product Name: ITF2357
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2021
Details:
Third regulatory designation Italfarmaco has received from the FDA for Givinostat after the Orphan Drug designation and Fast Track designation and reflects the agency’s recognition of Givinostat’s potential to treat DMD, a devastating genetic disease.
Lead Product(s): Givinostat
Therapeutic Area: Genetic Disease Product Name: ITF2357
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 09, 2020
Details:
The Interim data from EPYDIS Phase 3 trial shows that the trial is NOT FUTILE and the Independent Data Monitoring Committee recommends trial continuation.
Lead Product(s): Givinostat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2020
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