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 : 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 : 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
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