[{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Suspension","sponsorNew":"Italfarmaco S.p.A \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Italfarmaco S.p.A \/ Not Applicable"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Suspension","sponsorNew":"Italfarmaco S.p.A \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Italfarmaco S.p.A \/ Not Applicable"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral suspension","sponsorNew":"Italfarmaco S.p.A \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Italfarmaco S.p.A \/ Not Applicable"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Givinostat HCl","moa":"HDAC","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Italfarmaco S.p.A \/ Not Applicable"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Syneos Health","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"Givinostat HCl","moa":"","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Syneos Health","highestDevelopmentStatusID":"10","companyTruncated":"Italfarmaco S.p.A \/ Syneos Health"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Small molecule","year":"2024","type":"Not Applicable","leadProduct":"Givinostat HCl","moa":"","graph1":"Genetic Disease","graph2":"Approved","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Italfarmaco S.p.A \/ Not Applicable"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"Givinostat HCl","moa":"","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Suspension","sponsorNew":"Italfarmaco S.p.A \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Italfarmaco S.p.A \/ Not Applicable"},{"orgOrder":0,"company":"PANTHERx Rare Pharmacy","sponsor":"ITF Therapeutics","pharmaFlowCategory":"D","therapeuticArea":"Genetic Disease","country":"U.S.A","productType":"Small molecule","year":"2024","type":"Partnership","leadProduct":"Givinostat HCl","moa":"","graph1":"Genetic Disease","graph2":"Approved","graph3":"PANTHERx Rare Pharmacy","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"","sponsorNew":"PANTHERx Rare Pharmacy \/ ITF Therapeutics","highestDevelopmentStatusID":"12","companyTruncated":"PANTHERx Rare Pharmacy \/ ITF Therapeutics"},{"orgOrder":0,"company":"Italfarmaco S.p.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Small molecule","year":"2024","type":"Not Applicable","leadProduct":"Givinostat HCl","moa":"","graph1":"Genetic Disease","graph2":"Approved","graph3":"Italfarmaco S.p.A","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"","sponsorNew":"Italfarmaco S.p.A \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Italfarmaco S.p.A \/ Not Applicable"},{"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"}]

Find Clinical Drug Pipeline Developments & Deals for Givinostat HCl

Menu
Xls
Filters Filter
×
FILTER:
filter
Company Name
filter

Year

filter

DEALS // DEV.

filter

Country

filter
Sponsor
filter

Therapeutic Area

filter

Study Phase

filter

Deal Type

filter

Product Type

filter

Dosage Form

filter

Lead Product

filter

Target

Therapeutic Area by Lead Product

ForexGraph

Study Phase by Lead Product

ForexGraph

Company by Lead Product

ForexGraph

Top Deals by Deal Size (USD bn)

ForexGraph

01

ELCC
Not Confirmed
ELCC
Not Confirmed

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

blank

02

ELCC
Not Confirmed
ELCC
Not Confirmed

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 : Small molecule

Upfront Cash : Undisclosed

July 25, 2024

Lead Product(s) : Givinostat HCl

Therapeutic Area : Genetic Disease

Highest Development Status : Approved

Sponsor : ITF Therapeutics

Deal Size : Undisclosed

Deal Type : Partnership

blank

03

ELCC
Not Confirmed
ELCC
Not Confirmed

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 : Small molecule

Upfront Cash : Not Applicable

July 25, 2024

Lead Product(s) : Givinostat HCl

Therapeutic Area : Genetic Disease

Highest Development Status : Approved

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

blank

04

ELCC
Not Confirmed
ELCC
Not Confirmed

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 : Small molecule

Upfront Cash : Not Applicable

March 21, 2024

Lead Product(s) : Givinostat HCl

Therapeutic Area : Genetic Disease

Highest Development Status : Approved

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

blank

05

ELCC
Not Confirmed
ELCC
Not Confirmed

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 : Small molecule

Upfront Cash : Not Applicable

November 29, 2023

Lead Product(s) : Givinostat HCl

Therapeutic Area : Genetic Disease

Highest Development Status : Phase III

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

blank

06

ELCC
Not Confirmed
ELCC
Not Confirmed

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 : Small molecule

Upfront Cash : Not Applicable

June 29, 2023

Lead Product(s) : Givinostat HCl

Therapeutic Area : Genetic Disease

Highest Development Status : Phase III

Sponsor : Syneos Health

Deal Size : Not Applicable

Deal Type : Not Applicable

blank

07

ELCC
Not Confirmed
ELCC
Not Confirmed

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 : Small molecule

Upfront Cash : Not Applicable

June 25, 2022

Lead Product(s) : Givinostat HCl

Therapeutic Area : Genetic Disease

Highest Development Status : Phase III

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

blank

08

ELCC
Not Confirmed
ELCC
Not Confirmed

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 : ITF2357

Product Type : Small molecule

Upfront Cash : Not Applicable

February 22, 2021

Lead Product(s) : Givinostat HCl

Therapeutic Area : Genetic Disease

Highest Development Status : Phase III

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

blank

09

ELCC
Not Confirmed
ELCC
Not Confirmed

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 : Small molecule

Upfront Cash : Not Applicable

October 09, 2020

Lead Product(s) : Givinostat HCl

Therapeutic Area : Genetic Disease

Highest Development Status : Phase III

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

blank

10

ELCC
Not Confirmed
ELCC
Not Confirmed

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 : Undisclosed

Product Type : Small molecule

Upfront Cash : Not Applicable

April 27, 2020

Lead Product(s) : Givinostat HCl

Therapeutic Area : Genetic Disease

Highest Development Status : Phase III

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

blank