Resources
New PBC Drugs Monitor
(last checked: 25/5/2025)
Elafibranor (Iqirvo®) : Available ❌ |
HSE HT Approval ❌ |
NCPE (HTA ID: 25005)⌛ |
IQIRVO (Ipsen) |
EMA Approval ✅ |
ELATIVE® Trial
Seladelpar (Lyvdelzi®) : Available ❌ |
HSE HT Approval ❌ |
NCPE (HTA ID: N)❌ |
Lyvdelzi® (Gilead) |
EMA Approval ✅ |
ASSURE Trial,
RESPONSE Trial
Investigational Therapies (in the pipeline)
There are several new drugs in early to mid-stage development for PBC. Some focus on relieving pruritus by reducing bile acid levels through inhibition of bile acid transport (IBAT). Others aim to address both cholestasis and metabolic dysfunction by targeting nuclear receptors (PPARα/γ) involved in lipid and bile acid metabolism. Additional candidates are designed to reduce liver inflammation and fibrosis, offering potential benefits in slowing disease progression.
(last checked: 2/6/2025)
• Volixibat (Mirum Pharmaceuticals): An IBAT inhibitor in Phase IIb trials. Shows strong anti-pruritic effects and bile acid reduction.
• Linerixibat (GlaxoSmithKline): An IBAT inhibitor in Phase III trials, focusing on alleviating pruritus associated with PBC.
• Saroglitazar (Zydus Lifesciences): A dual PPARα/γ agonist in Phase IIb/III trials. It targets both cholestasis and metabolic dysfunction in PBC.
• Cilofexor (Gilead Sciences): FXR agonist, Phase: II, Showed significant reductions in ALP, GGT, and CRP in patients not responding to UDCA, with a tolerable side-effect profile.
• Setanaxib (Genkyotex/Ipsen): NOX1/4 inhibitor. Phase: IIb/III. Targets liver fibrosis and inflammation, with early signs of efficacy in reducing fatigue and improving biochemical markers.
Tips for living with PBC
Primary Biliary Cholangitis (Irish Liver Foundation)
Living with primary biliary cholangitis (British Liver Trust)
Primary biliary cholangitis (PBC) - Living with your diagnosis (Canadian PBC Society)
Primary biliary cholangitis: Lifestyle do's and don'ts (Mayo Clinic)
Primary Biliary Cholangitis (PBC): Living With This Chronic Disease (Cleveland Clinic)
Diet and wellness tips
The PBC Diet: What to Eat, What to Avoid (American Liver Foudation)
Using Food To Manage Primary Biliary Cholangitis (Cleveland Clinic)
Primary biliary cholangitis: Your guide to diet and nutrition (Mayo Clinic)
Health Eating (Canadian PBC Society)
Useful Websites (Irish)
Beaumont Hospital (Hepatology Dept.)
Irish Liver Foundation
Mater Hospital (Centre for Liver Disease)
St. James' (Hepatology Centre)
St. Vincent's (Hepatology Dept.)
Liver Ireland Support Network (LISN)
Useful Websites (International)
PBC Foundation (UK)
PBCers (USA)
American Liver Foundation (USA)
Canadian PBC Society (Canada)
Cleveland Clinic (USA)
PBC in the News (The latest 5 articles from Google News)
13/11/2025 Defining Elafibranor’s Role in a New Era of PBC Management, With Cynthia Levy, MD - HCPLive
12/11/2025 Seladelpar Eases PBC-Related Itch for 30 Months - MedPage Today
Guidelines
Primary biliary cholangitis (PBC) - Living with your diagnosis (Canadian PBC Society)
Diagnosis and Treatment of Primary Biliary Cholangitis: A Patient‐Friendly Summary of the 2018 AASLD Practice Guidance
PBC primary biliary cholangitis treatment and management guidelines (the British Society of Gastroenterology/UK)
EASL Clinical Practice Guidelines: The Diagnosis and management of patients with Primary Biliary Cholangitis (Lay terms)
EASL Clinical Practice Guidelines: The Diagnosis and management of patients with Primary Biliary Cholangitis (Journal of Hepatology)
Publications (The latest 5 articles from PubMed)
Popescu I. 2025. PPARevolution. First PPARδ Agonist and a Dual PPARα/PPARδ Activator Approved for the Treatment of Primary Biliary Cholangitis. J Cell Mol Med (Nov 2025)
Pei Y, et al. 2025. Letter on 'Non-Response to Obeticholic Acid Is Associated With Heightened Risks of Developing Clinical Events in Primary Biliary Cholangitis'. Aliment Pharmacol Ther (Nov 2025)
Tang X, You X. 2025. Progress and prospects of gut microbiota-targeted therapy for primary biliary cholangitis. Gut Pathog (Nov 2025)
Tana MM, Hirschfield GM. 2025. Primary Biliary Cholangitis. JAMA (Nov 2025)
Lakshmanan V, Morris L. 2025. Beyond Ursodeoxycholic Acid: A Comprehensive Review of Second-Line Agents in Primary Biliary Cholangitis. Cureus (Oct 2025)
Media
Press Contact: Gerry Nesbitt, gerry@PBCireland.org
