VivoSeq
Gastroenterology

Primary Biliary Cholangitis

35

Pipeline Programs↗

22

Active Trials↗

26

Companies Involved↗

Primary Biliary Cholangitis is a moderately active landscape with 35 programs across 26 companies. The most active players are Jagotec, GSK, Cara Therapeutics, Inc.. 4 therapies are approved with 8 more in late-stage development.

Intelligence

Pipeline Metrics

Competitive Density

58/100

Pipeline Velocity

15/100

Mech. Concentration

14/100

Completion Rate

75/100

Attrition Rate

13/100

Competition

Competitive Landscape

Bubble size = clinical trials

Approved
Phase 3
Phase 2
Phase 1
Preclinical

Key Players

Top Companies Companies ranked by the number of pipeline programs they run for this disease.

J

Jagotec

1 program

Phase 1GSK logo

GSK

1 program

Phase 2C

Cara Therapeutics, Inc.

1 program

Phase 2H

HighTide Biopharma Pty Ltd

1 program

Phase 2C

Calliditas Therapeutics AB

1 program

Phase 2C

Calliditas Therapeutics Suisse SA

1 program

Phase 2

Pipeline

Programs by Phase

Analysis

Trial Status

61

clinical trials

Completed24 · 39%
Recruiting12 · 20%
Terminated8 · 13%
Unknown status6 · 10%
Active, not recruiting6 · 10%
Not yet recruiting3 · 5%
Other2 · 3%

Clinical Trials

Trial Activity

61 trials

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Recruiting·ZZydus Therapeutics Inc.·Phase 3·NCT06427395·150 enrolled
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
Recruiting·MMirum Pharmaceuticals, Inc.·Phase 2·NCT05050136·260 enrolled
Fenofibrate in Primary Biliary Cholangitis: a Real World Study
Recruiting·XXijing Hospital of Digestive Diseases·Phase 3·NCT06755151·300 enrolled
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study
Recruiting·XXijing Hospital of Digestive Diseases·Phase 3·NCT06755541·150 enrolled
Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
Recruiting·XXijing Hospital of Digestive Diseases·Phase 3·NCT05751967·150 enrolled
Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis
Recruiting·XXijing Hospital of Digestive Diseases·Phase 2/3·NCT05749822·104 enrolled
Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
Recruiting·XXijing Hospital of Digestive Diseases·Phase 1·NCT07104201·15 enrolled
Efficacy and Safety of Bezafibrate 400 mg and Bezafibrate 200 mg as Adjunctive Treatments in Patients With Primary Biliary Cholangitis and Non-optimal Biochemical Response to Ursodeoxycholic Acid Therapy
Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT06443606·108 enrolled
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Recruiting·XXijing Hospital of Digestive Diseases·Phase 2/3·NCT06365424·117 enrolled
A Randomized, Double-Blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of CS0159 in Patients With Primary Biliary Cholangitis (PBC) With Inadequate Response or Intolerance to Ursodeoxycholic Acid (UDCA)
Recruiting·CCascade Pharmaceuticals, Inc·Phase 3·NCT07282353·135 enrolled
Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg/Day in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.
Recruiting·Ipsen logoIpsen·N/A·NCT06447168·424 enrolled
AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Recruiting·Gilead logoGilead·Phase 3·NCT06051617·318 enrolled
Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
Active, not recruiting·Gilead logoGilead·Phase 3·NCT03301506·500 enrolled
Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)
Active, not recruiting·Gilead logoGilead·Phase 3·NCT06060665·90 enrolled
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis
Active, not recruiting·—·Phase 2/3·NCT06174402·184 enrolled
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Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)