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    [{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Medis","pharmaFlowCategory":"D","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Other Small Molecule","year":"2025","type":"Agreement","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Approved FDF","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Suspension","sponsorNew":"Italfarmaco S.p.A \/ Medis","highestDevelopmentStatusID":"15","companyTruncated":"Italfarmaco S.p.A \/ Medis"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Other Small Molecule","year":"2024","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Approved FDF","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Suspension","sponsorNew":"Italfarmaco S.p.A \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Italfarmaco S.p.A \/ Inapplicable"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Other Small Molecule","year":"2024","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Approved FDF","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Suspension","sponsorNew":"Italfarmaco S.p.A \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Italfarmaco S.p.A \/ Inapplicable"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Other Small Molecule","year":"2021","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Approved FDF","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Suspension","sponsorNew":"Italfarmaco S.p.A \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Italfarmaco S.p.A \/ Inapplicable"},{"orgOrder":0,"company":"The Italfarmaco Group","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Other Small Molecule","year":"2023","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Phase III","graph3":"The Italfarmaco Group","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Suspension","sponsorNew":"The Italfarmaco Group \/ Inapplicable","highestDevelopmentStatusID":"10","companyTruncated":"The Italfarmaco Group \/ Inapplicable"},{"orgOrder":0,"company":"The Italfarmaco Group","sponsor":"Syneos Health","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Other Small Molecule","year":"2023","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Phase III","graph3":"The Italfarmaco Group","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Suspension","sponsorNew":"The Italfarmaco Group \/ Syneos Health","highestDevelopmentStatusID":"10","companyTruncated":"The Italfarmaco Group \/ Syneos Health"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Other Small Molecule","year":"2020","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Approved FDF","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Suspension","sponsorNew":"Italfarmaco S.p.A \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Italfarmaco S.p.A \/ Inapplicable"},{"orgOrder":0,"company":"The Italfarmaco Group","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Other Small Molecule","year":"2022","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Phase III","graph3":"The Italfarmaco Group","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Suspension","sponsorNew":"The Italfarmaco Group \/ Inapplicable","highestDevelopmentStatusID":"10","companyTruncated":"The Italfarmaco Group \/ Inapplicable"},{"orgOrder":0,"company":"The Italfarmaco Group","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Other Small Molecule","year":"2020","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Phase III","graph3":"The Italfarmaco Group","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Suspension","sponsorNew":"The Italfarmaco Group \/ Inapplicable","highestDevelopmentStatusID":"10","companyTruncated":"The Italfarmaco Group \/ Inapplicable"},{"orgOrder":0,"company":"PANTHERx Rare Pharmacy","sponsor":"ITF Therapeutics","pharmaFlowCategory":"D","therapeuticArea":"Genetic Disease","country":"U.S.A","productType":"Other Small Molecule","year":"2024","type":"Partnership","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Approved FDF","graph3":"PANTHERx Rare Pharmacy","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Suspension","sponsorNew":"PANTHERx Rare Pharmacy \/ ITF Therapeutics","highestDevelopmentStatusID":"15","companyTruncated":"PANTHERx Rare Pharmacy \/ ITF Therapeutics"}]

    Find Clinical Drug Pipeline Developments & Deals for Givinostat hydrochloride

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    Givinostat hydrochloride

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                            01

                            Italfarmaco S.p.A

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                            Italfarmaco S.p.A

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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Approved FDF

                            Sponsor : Medis

                            Deal Size : Undisclosed

                            Deal Type : Agreement

                            DEALS_DEV arrow-down

                            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

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                            02

                            Italfarmaco S.p.A

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                            Italfarmaco S.p.A

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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Approved FDF

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            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

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                            03

                            PANTHERx Rare Pharmacy

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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Approved FDF

                            Sponsor : ITF Therapeutics

                            Deal Size : Undisclosed

                            Deal Type : Partnership

                            DEALS_DEV arrow-down

                            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.

                            Product Name : Duvyzat

                            Product Type : Other Small Molecule

                            Upfront Cash : Undisclosed

                            July 25, 2024

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Approved FDF

                            Sponsor : ITF Therapeutics

                            Deal Size : Undisclosed

                            Deal Type : Partnership

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                            04

                            Italfarmaco S.p.A

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                            Italfarmaco S.p.A

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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Approved FDF

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            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

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                            05

                            The Italfarmaco Group

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                            The Italfarmaco Group

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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            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.

                            Product Name : ITF2357

                            Product Type : Other Small Molecule

                            Upfront Cash : Inapplicable

                            November 29, 2023

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            06

                            The Italfarmaco Group

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                            The Italfarmaco Group

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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Syneos Health

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Italfarmaco Group Completes FDA Submission of New Drug Application for Givinostat in Duchenne Muscular Dystrop...

                            Details : ITF2357 (givinostat) is an investigational drug act as a inhibits histone deacetylases (HDACs), which is investigated for the treatment of Duchenne Muscular Dystrophy.

                            Product Name : ITF2357

                            Product Type : Other Small Molecule

                            Upfront Cash : Inapplicable

                            June 29, 2023

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Syneos Health

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            07

                            The Italfarmaco Group

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                            The Italfarmaco Group

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                            Peptide Therapy Summit
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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Italfarmaco Group Announces Positive Topline Data from Phase 3 Trial Showing Beneficial Effect of Givinostat i...

                            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...

                            Product Name : ITF2357

                            Product Type : Other Small Molecule

                            Upfront Cash : Inapplicable

                            June 25, 2022

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            08

                            Italfarmaco S.p.A

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                            Italfarmaco S.p.A

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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Italfarmaco Provides Update on Ongoing Clinical Programs with Givinostat in Oral Presentation at XVIII Interna...

                            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

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                            09

                            The Italfarmaco Group

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                            The Italfarmaco Group

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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Italfarmaco Gets FDA Rare Pediatric Disease Designation for Givinostat in Duchenne Muscular Dystrophy

                            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...

                            Product Name : ITF2357

                            Product Type : Other Small Molecule

                            Upfront Cash : Inapplicable

                            September 10, 2020

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            10

                            Italfarmaco S.p.A

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                            Italfarmaco S.p.A

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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Italfarmaco Provides Update on Advanced-Stage Clinical Development Program with Givinostat in Duchenne Muscula...

                            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

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