Primary Biliary Cirrhosis

Gastroenterology
9
Pipeline Programs
6
Companies
8
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
4
0
3
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 7 programs with unclassified modality

On Market (1)

Approved therapies currently available

Bristol Myers Squibb
ORENCIAApproved
abatacept
Bristol Myers Squibb
Selective T Cell Costimulation Modulator [EPC]iv (infusion)2005

Competitive Landscape

6 companies ranked by most advanced pipeline stage

Bristol Myers Squibb
1 program
1
abataceptPhase 41 trial
Active Trials
NCT02078882Completed16Est. Oct 2018
GS
Gilead SciencesFOSTER CITY, CA
2 programs
1
1
Seladelpar 5 mg CapsulePhase 31 trial
MBX-8025 2 mg CapsulePhase 21 trial
Active Trials
NCT02955602Completed119Est. Jul 2019
NCT03301506Active Not Recruiting500Est. Nov 2028
CT
2 programs
1
1
Obeticholic Acid TabletsPhase 31 trial
TQA3526Phase 21 trial
Active Trials
NCT04278820UnknownEst. Nov 2022
NCT04956328UnknownEst. Sep 2023
Ipsen
IpsenChina - Tianjin
1 program
1
Elafibranor 80mgPhase 31 trial
Active Trials
NCT04526665Active Not Recruiting161Est. Dec 2028
Mirum Pharmaceuticals
Mirum PharmaceuticalsFOSTER CITY, CA
1 program
1
LUM001Phase 21 trial
Active Trials
NCT02321306Withdrawn0Est. Mar 2018
UP
UCB PharmaBelgium - Brussels
1 program
1
MoexiprilPhase 2Small Molecule1 trial
Active Trials
NCT00588302Completed20Est. Jun 2007

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Bristol Myers Squibbabatacept
Chia Tai TianQing Pharmaceutical GroupObeticholic Acid Tablets
IpsenElafibranor 80mg
Gilead SciencesSeladelpar 5 mg Capsule
Chia Tai TianQing Pharmaceutical GroupTQA3526
Gilead SciencesMBX-8025 2 mg Capsule
Mirum PharmaceuticalsLUM001
UCB PharmaMoexipril

Clinical Trials (8)

Total enrollment: 816 patients across 8 trials

NCT02078882Bristol Myers Squibbabatacept

Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis

Start: Sep 2014Est. completion: Oct 201816 patients
Phase 4Completed
NCT04956328Chia Tai TianQing Pharmaceutical GroupObeticholic Acid Tablets

Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)

Start: Jul 2021Est. completion: Sep 2023
Phase 3Unknown
NCT04526665IpsenElafibranor 80mg

Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)

Start: Sep 2020Est. completion: Dec 2028161 patients
Phase 3Active Not Recruiting
NCT03301506Gilead SciencesSeladelpar 5 mg Capsule

Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

Start: Dec 2017Est. completion: Nov 2028500 patients
Phase 3Active Not Recruiting
NCT04278820Chia Tai TianQing Pharmaceutical GroupTQA3526

A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC)

Start: Mar 2020Est. completion: Nov 2022
Phase 2Unknown
NCT02955602Gilead SciencesMBX-8025 2 mg Capsule

Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)

Start: Nov 2016Est. completion: Jul 2019119 patients
Phase 2Completed
NCT02321306Mirum PharmaceuticalsLUM001

An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis

Start: May 2015Est. completion: Mar 20180
Phase 2Withdrawn
NCT00588302UCB PharmaMoexipril

Moexipril for Primary Biliary Cirrhosis

Start: Jun 2003Est. completion: Jun 200720 patients
Phase 2Completed

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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

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

Related Indications

Hepatic Impairment(79)Gastroesophageal Reflux Disease(37)Irritable Bowel Syndrome(29)Gastroesophageal Reflux(27)Liver Transplantation(24)Celiac Disease(23)Hepatic Insufficiency(22)Liver Cirrhosis(22)Gastroesophageal Reflux Disease (GERD)(14)Hepatic Encephalopathy(12)