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)
05/12/2025 Primary Biliary Cholangitis Treatment Market to Reach US$2.72 - openPR.com
05/12/2025 Strength and Spirit: Anna’s Experience with a Rare Liver Disease - Reader's Digest
03/12/2025 Shifts in Blood Lipids Linked to Early Primary Biliary Cholangitis - European Medical Journal
28/11/2025 Pruritus Exhausts Patients With Primary Sclerosing Cholangitis - Medscape
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)
Kumar S, et al. 2025. Economic Burden of Primary Biliary Cholangitis by Line of Therapy in the United States. Adv Ther (Dec 2025)
Vierling JM, et al. 2025. Fracture events in patients with primary biliary cholangitis during treatment with seladelpar in the phase III RESPONSE trial. Hepatol Commun (Dec 2025)
Haque T, et al. 2025. AMA-Negative Primary Biliary Cholangitis and Autoimmune Hepatitis Overlap Syndrome Presenting With Bullous Pemphigoid: A Case Report. Clin Case Rep (Dec 2025)
Rogalska M, et al. 2025. Altered sphingolipid profile in primary biliary cholangitis: associations with fibrosis and inflammation. Sci Rep (Nov 2025)
Mandea M, et al. 2025. Profile of Patients with Primary Biliary Cholangitis and Evaluation of Response to Ursodeoxycholic Acid in a Romanian Center-Retrospective Study. J Clin Med (Nov 2025)
Media
Press Contact: Gerry Nesbitt, gerry@PBCireland.org
