Primary Biliary Cholangitis

15
Pipeline Programs
6
Companies
11
Clinical Trials
2 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
1
4
0
7
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 12 programs with unclassified modality

On Market (2)

Approved therapies currently available

Ipsen
IQIRVOApproved
elafibranor
Ipsen
Peroxisome Proliferator-activated Receptor Agonist [EPC]oral2024
GS
LIVDELZIApproved
seladelpar lysine
Gilead Sciences
oral2024

Competitive Landscape

6 companies ranked by most advanced pipeline stage

GS
Gilead SciencesFOSTER CITY, CA
7 programs
1
1
5
1
LIVDELZI(Seladelpar)Phase 31 trial
SeladelparPhase 3
Seladelpar 10 mgPhase 31 trial
Seladelpar 10 mgPhase 3
seladelpar 5-10 mgPhase 31 trial
+2 more programs
Active Trials
NCT04950764Completed24Est. Feb 2025
NCT02943447Terminated71Est. Sep 2019
NCT06051617Recruiting318Est. Aug 2030
+2 more trials
Ipsen
IpsenChina - Tianjin
2 programs
2
1
ElafibranorPhase 31 trial
ElafibranorPhase 31 trial
Active Trials
NCT06383403Active Not Recruiting69Est. Jun 2026
NCT06730061Active Not Recruiting18Est. Apr 2032
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
1 program
1
BaricitinibPhase 2Small Molecule1 trial
Active Trials
NCT03742973Terminated2Est. Sep 2019
E
EisaiChina - Liaoning
1 program
1
E6011Phase 21 trial
Active Trials
NCT03092765Terminated29Est. Oct 2018
Mirum Pharmaceuticals
Mirum PharmaceuticalsFOSTER CITY, CA
1 program
1
VolixibatPhase 21 trial
Active Trials
NCT05050136Recruiting260Est. Jul 2027
COUR Pharmaceuticals
1 program
1
CNP-104Phase 1/21 trial
Active Trials
NCT05104853Active Not RecruitingEst. Jan 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
IpsenElafibranor
IpsenElafibranor
Gilead SciencesSeladelpar
Gilead SciencesSeladelpar 10 mg
Gilead Sciencesseladelpar 5-10 mg
Mirum PharmaceuticalsVolixibat
Eli Lilly and CompanyBaricitinib
EisaiE6011
Gilead SciencesCilofexor
COUR PharmaceuticalsCNP-104
Gilead SciencesSeladelpar 10 mg

Clinical Trials (11)

Total enrollment: 1,249 patients across 11 trials

NCT06730061IpsenElafibranor

A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)

Start: Jan 2025Est. completion: Apr 203218 patients
Phase 3Active Not Recruiting
NCT06383403IpsenElafibranor

A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

Start: Jul 2024Est. completion: Jun 202669 patients
Phase 3Active Not Recruiting

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

Start: Sep 2023Est. completion: Aug 2030318 patients
Phase 3Recruiting

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start: Apr 2021Est. completion: Aug 2023193 patients
Phase 3Completed
NCT03602560Gilead Sciencesseladelpar 5-10 mg

ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start: Oct 2018Est. completion: Feb 2020265 patients
Phase 3Completed

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

Start: Sep 2021Est. completion: Jul 2027260 patients
Phase 2Recruiting

A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA

Start: Mar 2019Est. completion: Sep 20192 patients
Phase 2Terminated

Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid

Start: May 2017Est. completion: Oct 201829 patients
Phase 2Terminated

Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis

Start: Dec 2016Est. completion: Sep 201971 patients
Phase 2Terminated

Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects with Primary Biliary Cholangitis

Start: Jan 2022Est. completion: Jan 2026
Phase 1/2Active Not Recruiting

An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)

Start: Sep 2021Est. completion: Feb 202524 patients
Phase 1Completed

Phase Legend

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

Key Insights

7 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 1,249 patients
6 companies competing in this space