Skip to main content

Homocystinuria

2
Pipeline Programs
3
Companies
5
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
1
1
0
0
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

3 companies ranked by most advanced pipeline stage

March Biosciences
March BiosciencesTX - Houston
1 program
1
N-acetylcysteinePhase 21 trial
Active Trials
NCT00483314Completed5Est. Feb 2009
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
1 program
1
taurinePhase 1/21 trial
Active Trials
NCT01192828Completed15Est. Dec 2017
Travere Therapeutics
3 programs
PegtibatinasePHASE_1_21 trial
PegtibatinasePHASE_31 trial
PegtibatinasePHASE_31 trial
Active Trials
NCT03406611Active Not Recruiting32Est. Dec 2026
NCT06247085Active Not Recruiting70Est. Jan 2026
NCT06431893Enrolling By Invitation100Est. Jan 2027

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Travere TherapeuticsPegtibatinase
Travere TherapeuticsPegtibatinase
March BiosciencesN-acetylcysteine
Travere TherapeuticsPegtibatinase
Colorado Therapeuticstaurine

Clinical Trials (5)

Total enrollment: 222 patients across 5 trials

A Phase 3 Long-term Extension Study to Assess the Long-term Safety and Efficacy of Pegtibatinase Treatment in Participants ≥5 to ≤65 Years of Age With Classical Homocystinuria (HCU) (ENSEMBLE)

Start: Apr 2024Est. completion: Jan 2027100 patients
Phase 3Enrolling By Invitation

A Study to Investigate Efficacy and Safety of Pegtibatinase Compared With Placebo in Participants ≥12 to ≤65 Years of Age With Classical Homocystinuria (HCU) Due to Cystathionine Beta Synthase Deficiency Receiving Standard of Care Treatment

Start: Dec 2023Est. completion: Jan 202670 patients
Phase 3Active Not Recruiting

Homocystinuria: Treatment With N-Acetylcysteine

Start: Nov 2007Est. completion: Feb 20095 patients
Phase 2Completed

Pegtibatinase As an Enzyme Therapy for Patients with Homocystinuria Caused by Cystathionine Beta-Synthase Deficiency (COMPOSE)

Start: Jan 2019Est. completion: Dec 202632 patients
Phase 1/2Active Not Recruiting

Oxidative Stress Markers In Inherited Homocystinuria And The Impact Of Taurine

Start: Jan 2010Est. completion: Dec 201715 patients
Phase 1/2Completed

Phase Legend

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

Key Insights

3 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.