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Primary Biliary Cholangitis

16
Pipeline Programs
18
Companies
21
Clinical Trials
3 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
9
0
4
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
2100%
+ 29 programs with unclassified modality

On Market (1)

Approved therapies currently available

Gilead Sciences
LIVDELZIApproved
seladelpar lysine
Gilead Sciences
oral2024

Competitive Landscape

18 companies ranked by most advanced pipeline stage

Gilead Sciences
Gilead SciencesFOSTER CITY, CA
7 programs
1
Seladelpar 10 mgPHASE_1
CilofexorPHASE_2
LIVDELZI(Seladelpar)PHASE_3
SeladelparPHASE_3
Seladelpar 10 mgPHASE_3
+2 more programs
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
1
ursodeoxycholic acidPhase 41 trial
Active Trials
NCT04650243Recruiting90Est. May 2025
Kite Pharma
Kite PharmaCA - El Segundo
6 programs
1
1
4
SeladelparPhase 31 trial
Seladelpar 10 mgPhase 31 trial
Seladelpar 10 mgPhase 31 trial
seladelpar 5-10 mgPhase 31 trial
CilofexorPhase 21 trial
+1 more programs
Active Trials
NCT04950764Completed24Est. Feb 2025
NCT02943447Terminated71Est. Sep 2019
NCT06051617Recruiting318Est. Aug 2030
+3 more trials
Prevail Therapeutics
1 program
1
BaricitinibPhase 2Small Molecule1 trial
Active Trials
NCT03742973Terminated2Est. Sep 2019
EA Pharma
EA PharmaJapan - Tokyo
1 program
1
E6011Phase 2
Enanta Pharmaceuticals
1 program
1
EDP-305 1 mgPhase 21 trial
Active Trials
NCT03394924Completed68Est. Jan 2020
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
1 program
1
EmtricitabinePhase 2
MSD
MSDIreland - Ballydine
1 program
1
EmtricitabinePhase 21 trial
Active Trials
NCT03954327Completed37Est. Jan 2024
HighTide Therapeutics
HighTide TherapeuticsChina - Shenzhen
1 program
1
HTD1801Phase 21 trial
Active Trials
NCT04604652Completed24Est. May 2022
Sandoz
SandozAustria - Kundl
1 program
1
Part 1: LJN452Phase 21 trial
Active Trials
NCT02516605Completed61Est. Aug 2018
Calliditas Therapeutics
Calliditas TherapeuticsSweden - Stockholm
1 program
1
SetanaxibPhase 21 trial
Active Trials
NCT05014672Completed76Est. Jul 2024
Syneos Health
Syneos HealthNC - Morrisville
2 programs
Obeticholic Acid 5 MGN/A1 trial
Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC PatientsN/A1 trial
Active Trials
NCT05293938Withdrawn0Est. Jul 2023
NCT05292872Completed4,577Est. Dec 2021
Ipsen
IpsenChina - Tianjin
2 programs
ElafibranorPHASE_31 trial
ElafibranorPHASE_31 trial
Active Trials
NCT06730061Active Not Recruiting18Est. Apr 2032
NCT06383403Active Not Recruiting69Est. Jun 2026
Autonomous Therapeutics
1 program
Ursodeoxycholic AcidN/A1 trial
Active Trials
NCT06309589Completed60Est. Dec 2023
COUR Pharmaceuticals
1 program
CNP-104PHASE_1_21 trial
Active Trials
NCT05104853Active Not RecruitingEst. Jan 2026
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
1 program
BaricitinibPHASE_2Small Molecule
Eisai
EisaiChina - Liaoning
1 program
E6011PHASE_21 trial
Active Trials
NCT03092765Terminated29Est. Oct 2018
Mirum Pharmaceuticals
Mirum PharmaceuticalsFOSTER CITY, CA
1 program
VolixibatPHASE_21 trial
Active Trials
NCT05050136Recruiting260Est. Jul 2027

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
UNION therapeuticsursodeoxycholic acid
IpsenElafibranor
IpsenElafibranor
Kite PharmaSeladelpar
Kite PharmaSeladelpar 10 mg
Kite PharmaSeladelpar 10 mg
Kite Pharmaseladelpar 5-10 mg
Calliditas TherapeuticsSetanaxib
Mirum PharmaceuticalsVolixibat
HighTide TherapeuticsHTD1801
MSDEmtricitabine
Prevail TherapeuticsBaricitinib
Enanta PharmaceuticalsEDP-305 1 mg
EisaiE6011
Kite PharmaCilofexor

Showing 15 of 21 trials with date data

Clinical Trials (21)

Total enrollment: 6,332 patients across 21 trials

NCT04650243UNION therapeuticsursodeoxycholic acid

Clinical Research of Tapering UDCA in PBC Patients With a Complete Response

Start: Jan 2020Est. completion: May 202590 patients
Phase 4Recruiting
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
NCT06060665Kite PharmaSeladelpar 10 mg

Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)

Start: Sep 2023Est. completion: Jun 202690 patients
Phase 3Active Not Recruiting
NCT04620733Kite PharmaSeladelpar 10 mg

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
NCT03602560Kite Pharmaseladelpar 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 Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness

Start: Feb 2022Est. completion: Jul 202476 patients
Phase 2Completed

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

Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis

Start: May 2021Est. completion: May 202224 patients
Phase 2Completed
NCT03954327MSDEmtricitabine

Combination Antiretroviral Therapy (cART) for PBC

Start: Mar 2021Est. completion: Jan 202437 patients
Phase 2Completed

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

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis

Start: Dec 2017Est. completion: Jan 202068 patients
Phase 2Completed

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
NCT02516605SandozPart 1: LJN452

A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients

Start: Sep 2015Est. completion: Aug 201861 patients
Phase 2Completed

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
NCT04950764Kite PharmaSeladelpar 10 mg

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

Start: Nov 2021Est. completion: Feb 202524 patients
Phase 1Completed
NCT05293938Syneos HealthObeticholic Acid 5 MG

A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients

Start: Mar 2022Est. completion: Jul 20230
N/AWithdrawn

The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis

Start: May 2021Est. completion: Dec 202360 patients
N/ACompleted
NCT05292872Syneos HealthReal-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients

Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients

Start: Jun 2015Est. completion: Dec 20214,577 patients
N/ACompleted

Related Jobs

Phase Legend

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

Key Insights

4 late-stage (Phase 3) programs, potential near-term approvals
3 actively recruiting trials targeting 6,332 patients
18 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.