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Biliary Atresia

1
Pipeline Programs
6
Companies
8
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
1
0
0
0
0
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

6 companies ranked by most advanced pipeline stage

Kimia Therapeutics
Kimia TherapeuticsCA - Berkeley
1 program
1
Umbilical Cord-Mesenchymal Stem CellsPhase 11 trial
Active Trials
NCT07797673Recruiting40Est. Dec 2028
T-Therapeutics
T-TherapeuticsUK - Cambridge
2 programs
Granulocyte Colony-Stimulating FactorPHASE_11 trial
FilgrastimPHASE_21 trial
Active Trials
NCT03395028Completed6Est. Jan 2020
NCT04373941UnknownEst. Oct 2025
Ipsen
IpsenChina - Tianjin
2 programs
OdevixibatPHASE_31 trial
OdevixibatPHASE_31 trial
Active Trials
NCT04336722Completed254Est. Jun 2026
NCT05426733Active Not Recruiting180Est. Oct 2026
Baxter International
1 program
CoSeal sprayN/A1 trial
Active Trials
NCT01745991Unknown126Est. Dec 2017
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
Intestinal Microbiome Composition in Infants With Biliary Atresia (BA)N/A1 trial
Active Trials
NCT03890536Withdrawn0Est. Mar 2032
Mirum Pharmaceuticals
Mirum PharmaceuticalsFOSTER CITY, CA
1 program
MaralixibatPHASE_21 trial
Active Trials
NCT04524390Completed75Est. Feb 2024

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
IpsenOdevixibat
IpsenOdevixibat
T-TherapeuticsFilgrastim
Mirum PharmaceuticalsMaralixibat
Kimia TherapeuticsUmbilical Cord-Mesenchymal Stem Cells
T-TherapeuticsGranulocyte Colony-Stimulating Factor
UNION therapeuticsIntestinal Microbiome Composition in Infants With Biliary Atresia (BA)
Baxter InternationalCoSeal spray

Clinical Trials (8)

Total enrollment: 681 patients across 8 trials

NCT05426733IpsenOdevixibat

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia

Start: Jul 2022Est. completion: Oct 2026180 patients
Phase 3Active Not Recruiting
NCT04336722IpsenOdevixibat

Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

Start: Jul 2020Est. completion: Jun 2026254 patients
Phase 3Completed
NCT04373941T-TherapeuticsFilgrastim

Part II: Granulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary Atresia

Start: Sep 2023Est. completion: Oct 2025
Phase 2Unknown
NCT04524390Mirum PharmaceuticalsMaralixibat

Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai

Start: Jul 2021Est. completion: Feb 202475 patients
Phase 2Completed
NCT07797673Kimia TherapeuticsUmbilical Cord-Mesenchymal Stem Cells

Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia

Start: Sep 2026Est. completion: Dec 202840 patients
Phase 1Recruiting
NCT03395028T-TherapeuticsGranulocyte Colony-Stimulating Factor

GCSF Adjunct Therapy for Biliary Atresia

Start: Jan 2018Est. completion: Jan 20206 patients
Phase 1Completed
NCT03890536UNION therapeuticsIntestinal Microbiome Composition in Infants With Biliary Atresia (BA)

Intestinal Microbiome Composition in Infants With Biliary Atresia (BA)

Start: Dec 2023Est. completion: Mar 20320
N/AWithdrawn
NCT01745991Baxter InternationalCoSeal spray

Trail to Investigate the Effectiveness of CoSeal in Reducing Adhesions Following the Kasai Hepatoportoenterostomy for Biliary Atresia

Start: Dec 2012Est. completion: Dec 2017126 patients
N/AUnknown

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 actively recruiting trials targeting 681 patients
6 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.