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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)

26/12/2025 Primary Biliary Cholangitis Treatment Market Analysis Report - openPR.com

23/12/2025 Vitamin D3 attenuates hepatic inflammation in primary biliary cholangitis by inhibiting TLR4/NF-κB mediated M1 macrophage polarization | Scientific Reports - Nature

21/12/2025 UDCA Use in Primary Biliary Cholangitis Associated With Reduced Cancer Risk: JAMA - Medical Dialogues

12/12/2025 Study Reveals Long-Term Financial Burden of Managing Primary Biliary Cholangitis in the United States - geneonline.com

11/12/2025 Current Liver Stiffness Best Predicts PBC Outcomes - EMJ

See All PBC in the News


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)

Romeo M, et al. 2025. The Personalized Management of Primary Biliary Cholangitis in the Era of Precision Medicine: Current Challenges and Future Perspectives. J Pers Med (Dec 2025)

Wang Z, et al. 2025. Vitamin D attenuates hepatic inflammation in primary biliary cholangitis by inhibiting TLR4/NF-κB mediated M1 macrophage polarization. Sci Rep (Dec 2025)

Chen Z, et al. 2025. The causal relationship between inflammatory bowel disease and primary biliary cholangitis: A bidirectional two-sample Mendelian randomization study. Medicine (Baltimore) (Dec 2025)

Li Y, et al. 2025. Systemic inflammatory response index: a novel predictor for cardiovascular disease risk in patients with primary biliary cholangitis. Eur J Med Res (Dec 2025)

Wang W, et al. 2025. Clinical outcomes and early- prognostic biomarkers of primary biliary cholangitis with ductopenia. Front Immunol (2025)

See 100 Publications


Media

Press Contact: Gerry Nesbitt, gerry@PBCireland.org

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