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Disease

Cholangitis

Late-stage therapeutic developmentEmerging research
MeSHCholangitis
4
Publications
19
Clinical trials
1
Related conditions
1
Associated genes
1
Related proteins
2018
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 6 clinical trials expected to report results, the earliest in Q4 2026.
  • 1 industry development reported.
Upcoming Milestones
Clinical Milestones8View
Results expected 5
Recently completed 2
Industry & Market1View
Activity timeline9

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Elafibranorapproved

Conditional marketing authorisation — Iqirvo is indicated for the treatment of primary biliary cholangitis (PBC) in combination… (2024)

Obeticholic acidapproved

Product authorisation ended — Ocaliva is indicated for the treatment of primary biliary cholangitis (also known as prim… (2024)

Clinical trials

14 sponsors · 1 new · 2 completed in the last 12 months (net +1)

The current development programme across all trial phases.

Clinical programme
19
All trials
6
Active
14
Late-stage
6
Completed
Late-stage studies

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis (PBC)

Phase 3 · Recruiting · Xijing Hospital of Digestive Diseases

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis (PBC)

Phase 3 · Recruiting · Xijing Hospital of Digestive Diseases

A Phase III, Open-label, Single Arm Study to Investigate the Efficacy and Safety of Elafibranor 80 mg in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)

Phase 3 · Active, not recruiting · Ipsen

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis

Phase 3 · Recruiting · Ipsen

Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

Phase 4 · Completed · Tongji Hospital

A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

Phase 3 · Completed · Ipsen
Recruiting

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis (PBC)

Phase 3 · Recruiting · Xijing Hospital of Digestive Diseases

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis (PBC)

Phase 3 · Recruiting · Xijing Hospital of Digestive Diseases

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis

Phase 3 · Recruiting · Ipsen

Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation

Phase 2 · Recruiting · Mayo Clinic
Recently completed

A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

Phase 3 · Completed · Ipsen

IDEAL: A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3 Study Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)

Phase 3 · Completed · Gilead Sciences

A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis

Phase 2/3 · Completed · Zydus Therapeutics Inc.

A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis

Phase 3 · Completed · Nanjing Chia-tai Tianqing Pharmaceutical

Combination Use of Intravenous Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography ; A Randomized Control Trial

Phase 2 · Completed · National University of Malaysia

Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

Phase 4 · Completed · Tongji Hospital

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2024emaConditional marketing authorisation — Elafibranor· Iqirvo is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. source ↗
Other regulatory activity
2024emaProduct authorisation ended — Obeticholic acid· Ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

4 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
2017–2018
Major themes6
  • Antibiotic Prophylaxis1
  • Cholangiopancreatography, Endoscopic Retrograde1
  • Cholangitis1
  • Cholestasis, Extrahepatic1
  • Endoscopy, Gastrointestinal1
  • Video Recording1
Leading journals4
  • Endoscopy1
  • Gastrointestinal endoscopy1
  • Gut1
  • Journal of hepato-biliary-pancreatic sciences1
Leading researchers8
  • Acosta RD1
  • Agrawal D1
  • Asai K1
  • Asbun HJ1
  • Beckingham I1
  • Belli G1
  • Blero D1
  • Bruining DH1
Affiliations (unnormalised)6
  • Academic Medical Center1
  • Ageo Central General Hospital1
  • Agia Olga Hospital1
  • Aintree University Hospital Liverpool1
  • Bournemouth Digestive Diseases Centre1
  • Catholic University1

Associated genes

1 match

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

NR1H40.37

Disease biology

1 match

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

Bile acid receptorvia NR1H40.37

Related conditions

1 match

Diseases frequently studied alongside this one. Number shows shared papers.

Pancreatitis2

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Inflammation of the biliary ductal system (BILE DUCTS); intrahepatic, extrahepatic, or both.

Identifiers
MeSHCholangitis
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.