NITYR
Peaknitisinone
NDAORALTABLET
Approved
Jul 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
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
Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1)
Started Mar 2016
24 enrolled
Hereditary Tyrosinemia, Type I
Bioavailability Food-Effect Study of an Oral Nitisinone Formulation to Treat Hereditary Tyrosinemia (HT-1)
Started Nov 2015
20 enrolled
Hereditary Tyrosinemia, Type I
Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin
Started Oct 2015
24 enrolled
Hereditary Tyrosinemia, Type I
Loss of Exclusivity
LOE Date
Jan 5, 2035
107 months away
Patent Expiry
Jan 5, 2035
Patent Records (1)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 10328029 | Jan 5, 2035 | Product | U-1836 |