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    [{"orgOrder":0,"company":"Italfarmaco","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"ITALY","productType":"Miscellaneous","year":"2023","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"enzyme inhibitors: inhibitors of histone deacetylase; vinca alkaloids","graph1":"Oncology","graph2":"Phase III","graph3":"Italfarmaco","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Capsule","sponsorNew":"Italfarmaco \/ Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"Italfarmaco \/ Undisclosed"},{"orgOrder":0,"company":"Italfarmaco","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Undisclosed","country":"ITALY","productType":"Miscellaneous","year":"2022","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"enzyme inhibitors: inhibitors of histone deacetylase; vinca alkaloids","graph1":"Undisclosed","graph2":"Phase 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Undisclosed"},{"orgOrder":0,"company":"Italfarmaco","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Undisclosed","country":"ITALY","productType":"Miscellaneous","year":"2023","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"enzyme inhibitors: inhibitors of histone deacetylase; vinca alkaloids","graph1":"Undisclosed","graph2":"Phase I","graph3":"Italfarmaco","amount2":0,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco \/ Undisclosed","highestDevelopmentStatusID":"6","companyTruncated":"Italfarmaco \/ Undisclosed"},{"orgOrder":0,"company":"Italfarmaco","sponsor":"Fortrea","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Miscellaneous","year":"2023","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"enzyme inhibitors: inhibitors of histone deacetylase; vinca alkaloids","graph1":"Genetic Disease","graph2":"Phase 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Group","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Miscellaneous","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":"Suspension","sponsorNew":"The Italfarmaco Group \/ Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"The Italfarmaco Group \/ Undisclosed"},{"orgOrder":0,"company":"The Italfarmaco Group","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Miscellaneous","year":"2022","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Phase III","graph3":"The Italfarmaco Group","amount2":0,"highestDevelopmentShortName":"Ph 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Disease","country":"ITALY","productType":"Miscellaneous","year":"2025","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Phase II","graph3":"Italfarmaco","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Italfarmaco \/ Fortrea","highestDevelopmentStatusID":"8","companyTruncated":"Italfarmaco \/ Fortrea"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Miscellaneous","year":"2024","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Approved FDF","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Italfarmaco S.p.A \/ Undisclosed"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Miscellaneous","year":"2024","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Approved FDF","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Italfarmaco S.p.A \/ Undisclosed"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Medis","pharmaFlowCategory":"D","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Miscellaneous","year":"2025","type":"Agreement","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Approved FDF","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Medis","highestDevelopmentStatusID":"15","companyTruncated":"Italfarmaco S.p.A \/ Medis"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Miscellaneous","year":"2025","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Approved FDF","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Italfarmaco S.p.A \/ Undisclosed"},{"orgOrder":0,"company":"Italfarmaco 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Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Italfarmaco S.p.A \/ Undisclosed"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Miscellaneous","year":"2021","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Approved FDF","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Italfarmaco S.p.A \/ Undisclosed"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Miscellaneous","year":"2020","type":"Inapplicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Approved FDF","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Italfarmaco S.p.A \/ Undisclosed"},{"orgOrder":0,"company":"PANTHERx Rare Pharmacy","sponsor":"ITF Therapeutics","pharmaFlowCategory":"D","therapeuticArea":"Genetic Disease","country":"U.S.A","productType":"Miscellaneous","year":"2024","type":"Partnership","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Approved FDF","graph3":"PANTHERx Rare Pharmacy","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"PANTHERx Rare Pharmacy \/ ITF Therapeutics","highestDevelopmentStatusID":"15","companyTruncated":"PANTHERx Rare Pharmacy \/ ITF Therapeutics"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Multicare","pharmaFlowCategory":"D","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Miscellaneous","year":"2025","type":"Agreement","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Approved FDF","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Multicare","highestDevelopmentStatusID":"15","companyTruncated":"Italfarmaco S.p.A \/ Multicare"}]

    Find Clinical Drug Pipeline Developments & Deals for Givinostat HCl

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    Givinostat HCl

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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 : Multicare

                            Deal Size : Undisclosed

                            Deal Type : Agreement

                            DEALS_DEV arrow-down

                            Italfarmaco Announces Exclusive Distribution Agreement with Multicare Pharma in Brazil

                            Details : Multicare Pharma will support the regulatory approval in Brazil and distribute Duvyzat (givinostat), Italfarmaco’s novel histone deacetylase (HDAC) inhibitor to treat Duchenne muscular dystrophy.

                            Product Name : Duvyzat

                            Product Type : Miscellaneous

                            Upfront Cash : Undisclosed

                            September 16, 2025

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Approved FDF

                            Sponsor : Multicare

                            Deal Size : Undisclosed

                            Deal Type : Agreement

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                            02

                            Italfarmaco S.p.A

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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            European Commission Approves Duvyzat for the Treatment of Duchenne Muscular Dystrophy

                            Details : Duvyzat (givinostat HCl)is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.

                            Product Name : Duvyzat

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            June 06, 2025

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            03

                            Italfarmaco S.p.A

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                            Italfarmaco S.p.A

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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Oncology

                            Study Phase : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Italfarmaco gets Fast Track Tag for Givinostat in Polycythemia Vera Treatment

                            Details : Duvyzat (givinostat HCl) is a histone deacetylase inhibitor, being investigated for the treatment of polycythaemia vera.

                            Product Name : Duvyzat

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            May 06, 2025

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Oncology

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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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 : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            CHMP Recommends EU Approval for Duvyzat to Treat 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 : Miscellaneous

                            Upfront Cash : Inapplicable

                            April 25, 2025

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            05

                            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 : Miscellaneous

                            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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                            06

                            Italfarmaco

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                            Italfarmaco

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                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase II

                            Sponsor : Fortrea

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old

                            Details : Givinostat HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Muscular Dystrophy, Duchenne.

                            Product Name : Undisclosed

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            January 10, 2025

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase II

                            Sponsor : Fortrea

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            07

                            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 : Undisclosed

                            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 : Miscellaneous

                            Upfront Cash : Inapplicable

                            July 25, 2024

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            08

                            PANTHERx Rare Pharmacy

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                            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 : Miscellaneous

                            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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                            09

                            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 : Undisclosed

                            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 : Miscellaneous

                            Upfront Cash : Inapplicable

                            March 21, 2024

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            10

                            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 : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            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 : Undisclosed

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            November 29, 2023

                            Lead Product(s) : Givinostat HCl

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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