NDAORALCAPSULEPriority Review
Approved
Jan 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Mechanism of Action
Hydroxyphenylpyruvate Dioxygenase Inhibitors
Pharmacologic Class:
4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor
Clinical Trials (5)
A Non-interventional, Post-Marketing Study to Describe Outcome of Nitisinone Treatment in HT-1 Patients
Started Sep 2025
0Hereditary Tyrosinemia, Type I
A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers
Started Mar 2017
36 enrolled
Drug Drug Interaction
Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1
Started Dec 2014
18 enrolled
Hereditary Tyrosinemia, Type I
Long Term Safety Study of Orfadin Treatment in HT-1 Patients in Standard Clinical Care
Started Sep 2013
315 enrolled
Hereditary Tyrosinemia, Type I
Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.
Started May 2013
12 enrolled
Healthy