5
ALL5
Italfarmaco S.p.AYear
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ALL1
20252
20241
20211
2020DEALS // DEV.
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Deals4
DevelopmentsCountry
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ITALY5
ALL4
Inapplicable1
MedisTherapeutic Area
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Genetic DiseaseStudy Phase
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Approved FDFDeal Type
5
ALL1
Agreement4
InapplicableProduct Type
5
ALL5
Other Small MoleculeDosage Form
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Oral SuspensionLead Product
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Givinostat HClTarget
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HDACLead Product(s) : Givinostat HCl
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Medis
Deal Size : Undisclosed
Deal Type : Agreement
Italfarmaco, Medis Sign Exclusive Deal for Givinostat in 17 European Nations
Details : Under the agreement, Medis will have exclusive distribution rights of Duvyzat (Givinostat HCl). It is being indicated for the treatment of DMD.
Product Name : Duvyzat
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
March 18, 2025
Lead Product(s) : Givinostat HCl
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Medis
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Givinostat HCl
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Duvyzat
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 25, 2024
Lead Product(s) : Givinostat HCl
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Givinostat HCl
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Duvyzat
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 21, 2024
Lead Product(s) : Givinostat HCl
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Givinostat HCl
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Duvyzat
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 22, 2021
Lead Product(s) : Givinostat HCl
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Givinostat HCl
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Duvyzat
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 27, 2020
Lead Product(s) : Givinostat HCl
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable