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Find Clinical Drug Pipeline Developments & Deals for Fosdenopterin

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01

Interphex
Not Confirmed
Interphex
Not Confirmed

Details : Nulibry (fosdenopterin) is the first therapy for patients in Great Britain with molybdenum cofactor deficiency Type A, an ultra-rare genetic disorder that often progresses rapidly in infants.

Product Name : Nulibry

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 16, 2024

Lead Product(s) : Fosdenopterin

Therapeutic Area : Rare Diseases and Disorders

Highest Development Status : Approved FDF

Sponsor : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

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02

Interphex
Not Confirmed
Interphex
Not Confirmed

Details : NULIBRY (fosdenopterin) is first and only approved therapy in U.S. and in Israel to treat patients with MoCD Type A, an ultra-rare, life-threatening genetic disorder that often progresses rapidly in infants with a median overall survival age of about fou...

Product Name : Nulibry

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 08, 2022

Lead Product(s) : Fosdenopterin

Therapeutic Area : Genetic Disease

Highest Development Status : Approved FDF

Sponsor : Sentynl Therapeutics

Deal Size : Inapplicable

Deal Type : Inapplicable

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03

Interphex
Not Confirmed
Interphex
Not Confirmed

Details : Nulibry (fosdenopterin) is a first-in-class cPMP substrate replacement therapy that was approved by the U.S. Food and Drug Administration (FDA) in 2021 to reduce the risk of mortality in patients with MoCD Type A.

Product Name : Nulibry

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 20, 2022

Lead Product(s) : Fosdenopterin

Therapeutic Area : Genetic Disease

Highest Development Status : Approved FDF

Sponsor : Sentynl Therapeutics

Deal Size : Inapplicable

Deal Type : Inapplicable

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04

Interphex
Not Confirmed
Interphex
Not Confirmed

Details : Under the Agreement, Sentynl will acquire global rights to NULIBRY and will be responsible for the ongoing development and commercialization of NULIBRY in the United States and developing, manufacturing and commercializing Fosdenopterin globally.

Product Name : Nulibry

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

August 03, 2022

Lead Product(s) : Fosdenopterin

Therapeutic Area : Genetic Disease

Highest Development Status : Approved FDF

Sponsor : Sentynl Therapeutics

Deal Size : Undisclosed

Deal Type : Agreement

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05

Peptide-Based Therapeutics Summit
Not Confirmed
Peptide-Based Therapeutics Summit
Not Confirmed

Details : CHMP recommendation for approval of NULIBRY (fosdenopterin) in European Union (EU) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A is based on the efficacy and safety data collected to date compared to data from a natural ...

Product Name : Nulibry

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 25, 2022

Lead Product(s) : Fosdenopterin

Therapeutic Area : Genetic Disease

Highest Development Status : Approved FDF

Sponsor : Sentynl Therapeutics

Deal Size : Inapplicable

Deal Type : Inapplicable

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06

Interphex
Not Confirmed
Interphex
Not Confirmed

Details : The efficacy of NULIBRY for the treatment of patients with MoCD Type A was established based on data from three clinical trials compared to data from a natural history study in which it showed a meaningful increase in overall survival compared to a natur...

Product Name : Nulibry

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 28, 2021

Lead Product(s) : Fosdenopterin

Therapeutic Area : Genetic Disease

Highest Development Status : Approved FDF

Sponsor : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

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07

Interphex
Not Confirmed
Interphex
Not Confirmed

Details : FDA has accepted its New Drug Application (NDA) for fosdenopterin, a cyclic pyranopterin monophosphate (cPMP) substrate replacement therapy, for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

Product Name : Nulibry

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 29, 2020

Lead Product(s) : Fosdenopterin

Therapeutic Area : Genetic Disease

Highest Development Status : Phase III

Sponsor : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

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