Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Dipharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Orfadin (nitisinone) is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1.
Product Name : Orfadin-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 31, 2023
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Dipharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
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 ...
Product Name : Nitisinone-Generic
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
April 10, 2023
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Eton Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Orfadin
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 18, 2020
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Nityr
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 14, 2020
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Study Phase : Undisclosed
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 03, 2019
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Highest Development Status : Undisclosed
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Nitisinone
Therapeutic Area : Undisclosed
Study Phase : Phase I
Sponsor : Parexel
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 06, 2017
Lead Product(s) : Nitisinone
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Sponsor : Parexel
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Study Phase : Phase I
Sponsor : Parexel
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 25, 2016
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Sponsor : Parexel
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Study Phase : Phase I
Sponsor : Parexel
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1)
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 25, 2016
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Sponsor : Parexel
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Study Phase : Phase I
Sponsor : Parexel
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 25, 2016
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Sponsor : Parexel
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 23, 2014
Lead Product(s) : Nitisinone
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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