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Primary Biliary Cholangitis (PBC)

4
Pipeline Programs
6
Companies
5
Clinical Trials
2 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
2
1
0
0
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

6 companies ranked by most advanced pipeline stage

Genfit
GenfitFrance - Loos
1 program
1
Elafibranor 80 mgPhase 21 trial
Active Trials
NCT03124108Completed45Est. Oct 2018
Cognition Therapeutics
Cognition TherapeuticsPA - Pittsburgh
1 program
1
golexanolonePhase 1/21 trial
Active Trials
NCT07304843Recruiting84Est. Jun 2026
Umecrine Cognition
Umecrine CognitionSweden - Solna
1 program
1
golexanolonePhase 1/2
Ohara Pharmaceutical
1 program
1
OP-724Phase 11 trial
Active Trials
NCT04047160Completed7Est. Mar 2022
Parvus Therapeutics
Parvus TherapeuticsCA - South SF
1 program
PVT201PHASE_11 trial
Active Trials
NCT06798454Completed24Est. Apr 2025
Ipsen
IpsenChina - Tianjin
1 program
ElafibranorPHASE_31 trial
Active Trials
NCT06016842Recruiting276Est. May 2029

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
IpsenElafibranor
GenfitElafibranor 80 mg
Cognition Therapeuticsgolexanolone
Parvus TherapeuticsPVT201
Ohara PharmaceuticalOP-724

Clinical Trials (5)

Total enrollment: 436 patients across 5 trials

NCT06016842IpsenElafibranor

A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis

Start: Aug 2023Est. completion: May 2029276 patients
Phase 3Recruiting
NCT03124108GenfitElafibranor 80 mg

Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

Start: Apr 2017Est. completion: Oct 201845 patients
Phase 2Completed
NCT07304843Cognition Therapeuticsgolexanolone

A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction

Start: Apr 2023Est. completion: Jun 202684 patients
Phase 1/2Recruiting
NCT06798454Parvus TherapeuticsPVT201

Single Ascending Dose Study to Evaluate Safety Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 in Healthy Subjects and Patients (PBC/PSC)

Start: Oct 2024Est. completion: Apr 202524 patients
Phase 1Completed
NCT04047160Ohara PharmaceuticalOP-724

Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)

Start: Aug 2019Est. completion: Mar 20227 patients
Phase 1Completed

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

2 actively recruiting trials targeting 436 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.