Homocystinuria

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

Competitive Landscape

1 companies ranked by most advanced pipeline stage

Travere Therapeutics
3 programs
1
2
PegtibatinasePhase 31 trial
PegtibatinasePhase 31 trial
PegtibatinasePhase 1/21 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
Travere TherapeuticsPegtibatinase

Clinical Trials (3)

Total enrollment: 202 patients across 3 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

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

Phase Legend

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

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
1 companies competing in this space