Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Eton Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Eton Pharmaceuticals Announces Acquisition of FDA-Approved Ultra-Rare Disease Product Nitisinone
Details : Through the acquisition, Eton gains access to an abbreviated new drug application for Nitisinone Capsules via Oakrum. Nitisinone is FDA approved or the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine ...
Brand Name : Nitisinone-Generic
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 04, 2023
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Eton Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Dipharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Orfadin (nitisinone) is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1.
Brand Name : Orfadin-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 31, 2023
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Dipharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Sobi's Orfadin® (nitisinone) Receives Positive Opinion from CHMP for Treatment of AKU
Details : European Medicines Agency (EMA) has adopted a positive opinion for Orfadin® (nitisinone) for the treatment of adult patients with alkaptonuria (AKU). The opinion is based on the scientific results of the DevelopAKUre clinical development programme.
Brand Name : Orfadin
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 18, 2020
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
US FDA Grants Once Daily Dosing Option for NITYR (nitisinone) Tablets for HT-1 Patients
Details : NITYR® is indicated for the treatment of patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Brand Name : Nityr
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 14, 2020
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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