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)
18/09/2025 Liver Lineup: Innovations in Cholestatic Disease Management, With Kris Kowdley, MD - HCPLive
13/09/2025 New Hope for People Living with PBC in Europe – ELPA - Oncodaily
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)
Cançado GGL, et al. 2025. High biochemical remission rates in patients with primary biliary cholangitis treated with "triple" anticholestatic therapy. Hepatol Commun (Oct 2025)
Zhang Z, Yang Z. 2025. Which Cells Play a Protective Role in Primary Biliary Cholangitis: Dendritic Cells or Others? Hepatol Res (Sep 2025)
Abbas N, et al. 2025. Non-Response to Obeticholic Acid Is Associated With Heightened Risks of Developing Clinical Events in Primary Biliary Cholangitis. Aliment Pharmacol Ther (Sep 2025)
Sirohi N, et al. 2025. Dismal Prognosis of Primary Biliary Cholangitis and Its Overlap with Autoimmune Hepatitis. J Clin Exp Hepatol (2025)
Nie Y, et al. 2025. Gut Microbiota: Implications in Pathogenesis and Potential Therapeutic Target in Primary Biliary Cholangitis. J Clin Transl Hepatol (Sep 2025)
Media
Press Contact: Gerry Nesbitt, gerry@PBCireland.org
