Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : ITF Therapeutics
Deal Size : Undisclosed
Deal Type : Partnership
PANTHERx®Rare Partnering with ITF Therapeutics LLC for U.S. Distribution of DUVYZAT™
Details : PANTHERx partners with ITF for the U.S. distribution of Duvyzat (givinostat), the approved product to treat patients with all genetic variants of Duchenne muscular dystrophy aged six years and older.
Brand Name : Duvyzat
Molecule Type : Small molecule
Upfront Cash : Undisclosed
July 25, 2024
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : ITF Therapeutics
Deal Size : Undisclosed
Deal Type : Partnership
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
ITF Therapeutics Announces U.S. Availability of DUVYZAT™ for Duchenne Muscular Dystrophy
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.
Brand Name : Duvyzat
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 25, 2024
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Italfarmaco Receives FDA Approval for Duvyzat™ (givinostat) in Duchenne Muscular Dystrophy
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.
Brand Name : Duvyzat
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 21, 2024
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Italfarmaco Group Announces New PDUFA Date for Givinostat DMD NDA
Details : ITF2357 (givinostat) is an HDAC Inhibitor small molecule drug, currently being investigated as an oral suspension for the treatment of Duchenne Muscular Dystrophy.
Brand Name : ITF2357
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 29, 2023
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Syneos Health
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : ITF2357 (givinostat) is an investigational drug act as a inhibits histone deacetylases (HDACs), which is investigated for the treatment of Duchenne Muscular Dystrophy.
Brand Name : ITF2357
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 29, 2023
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Syneos Health
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 pr...
Brand Name : ITF2357
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 25, 2022
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 treatmen...
Brand Name : ITF2357
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 22, 2021
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : ITF2357
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 09, 2020
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 27, 2020
Lead Product(s) : Givinostat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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