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Hereditary Tyrosinemia, Type I

0
Pipeline Programs
2
Companies
7
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
0
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Swedish Orphan Biovitrum
4 programs
NitisinoneN/A1 trial
NitisinoneN/A1 trial
NitisinonePHASE_11 trial
NitisinonePHASE_31 trial
Active Trials
NCT02320084Completed315Est. Sep 2019
NCT06227429Withdrawn0Est. Jun 2027
NCT01734889Completed18Est. Mar 2013
+1 more trials
Parexel
ParexelMA - Boston
3 programs
NitisinonePHASE_11 trial
NitisinonePHASE_11 trial
NitisinonePHASE_11 trial
Active Trials
NCT02750345Completed24Est. May 2016
NCT02750332Completed20Est. Jan 2016
NCT02750709Completed24Est. Jan 2016

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Swedish Orphan BiovitrumNitisinone
ParexelNitisinone
ParexelNitisinone
ParexelNitisinone
Swedish Orphan BiovitrumNitisinone
Swedish Orphan BiovitrumNitisinone
Swedish Orphan BiovitrumNitisinone

Clinical Trials (7)

Total enrollment: 419 patients across 7 trials

Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1

Start: Dec 2014Est. completion: Sep 201518 patients
Phase 3Completed

Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1)

Start: Mar 2016Est. completion: May 201624 patients
Phase 1Completed

Bioavailability Food-Effect Study of an Oral Nitisinone Formulation to Treat Hereditary Tyrosinemia (HT-1)

Start: Nov 2015Est. completion: Jan 201620 patients
Phase 1Completed

Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin

Start: Oct 2015Est. completion: Jan 201624 patients
Phase 1Completed

Taste and Palatability of Orfadin Suspension

Start: Oct 2012Est. completion: Mar 201318 patients
Phase 1Completed

A Non-interventional, Post-Marketing Study to Describe Outcome of Nitisinone Treatment in HT-1 Patients

Start: Sep 2025Est. completion: Jun 20270
N/AWithdrawn

Long Term Safety Study of Orfadin Treatment in HT-1 Patients in Standard Clinical Care

Start: Sep 2013Est. completion: Sep 2019315 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

2 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.