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Ornithine Transcarbamylase Deficiency

2
Pipeline Programs
3
Companies
6
Clinical Trials
1 recruiting
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

Drug Modality Breakdown

Gene Therapy
1100%
+ 2 programs with unclassified modality

Competitive Landscape

3 companies ranked by most advanced pipeline stage

Arcturus Therapeutics
Arcturus TherapeuticsCA - San Diego
1 program
1
ARCT-810Phase 24 trials
Active Trials
NCT06488313Recruiting9Est. Sep 2026
NCT05526066Terminated8Est. Oct 2024
NCT04442347Completed16Est. Apr 2024
+1 more trials
Biocorp
BiocorpFrance - Issoire
1 program
1
MRT5201Phase 1/21 trial
Active Trials
NCT03767270Withdrawn0Est. Jul 2022
Ultragenyx Pharmaceutical
1 program
Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson DiseaseN/AGene Therapy1 trial
Active Trials
NCT04909346Terminated51Est. Nov 2022

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Arcturus TherapeuticsARCT-810
Arcturus TherapeuticsARCT-810
BiocorpMRT5201
Arcturus TherapeuticsARCT-810
Arcturus TherapeuticsARCT-810
Ultragenyx PharmaceuticalAdeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease

Clinical Trials (6)

Total enrollment: 114 patients across 6 trials

A Study to Evaluate the Pharmacodynamics and Safety of ARCT-810 in Participants With OTCD

Start: Nov 2024Est. completion: Sep 20269 patients
Phase 2Recruiting

Study for Adolescents and Adults With Ornithine Transcarbamylase Deficiency to Evaluate Safety and Tolerability of ARCT-810

Start: Oct 2022Est. completion: Oct 20248 patients
Phase 2Terminated

Safety, Tolerability and PK/PD Evaluation of Intravenous Administration of MRT5201 in Patients With OTC Deficiency

Start: Dec 2019Est. completion: Jul 20220
Phase 1/2Withdrawn

Phase 1b Study to Assess Safety, Tolerability, and Pharmacokinetics of ARCT-810 in Stable Adult Subjects With Ornithine Transcarbamylase Deficiency

Start: Nov 2020Est. completion: Apr 202416 patients
Phase 1Completed

Safety, Tolerability and Pharmacokinetics of ARCT-810 in Healthy Adult Subjects

Start: Jun 2020Est. completion: Dec 202030 patients
Phase 1Completed
NCT04909346Ultragenyx PharmaceuticalAdeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease

Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease

Start: Jun 2021Est. completion: Nov 202251 patients
N/ATerminated

Phase Legend

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

Key Insights

1 actively recruiting trials targeting 114 patients
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.