Primary Biliary Cholangitis Pipeline Insight 2025: FXR Agonists, PPAR Modulators, and Novel Anti-Fibrotics Drive Development | DelveInsight

DelveInsight's "Primary Biliary Cholangitis (PBC) - Pipeline Insight, 2025" delves into the promising pipeline addressing this chronic autoimmune liver disease marked by bile duct inflammation, fibrosis, and cirrhosis. While ursodeoxycholic acid (UDCA) and obeticholic acid (Ocaliva) are current standards, a significant percentage of patients fail to respond adequately, necessitating novel therapies that can halt or reverse progression. The 2025 pipeline sees innovation from nuclear receptor modulators, anti-fibrotics, and bile acid regulators.

Key clinical-stage candidates include Seladelpar by CymaBay Therapeutics, a PPAR-delta agonist that has demonstrated significant improvements in alkaline phosphatase levels and symptom relief. Genfit's Elafibranor, a dual PPAR-alpha/delta agonist, is also being evaluated for anti-fibrotic and cholestatic effects. Additionally, Intercept Pharmaceuticals is advancing new-generation FXR agonists aimed at reducing pruritus and improving liver enzyme normalization. Early-phase programs from Mirum Pharmaceuticals and Albireo Pharma are exploring ASBT inhibitors and novel bile acid analogs.

With growing clinical focus on patient-reported outcomes, fatigue and itching-two of PBC's most debilitating symptoms-are becoming endpoints alongside biochemical markers. Regulatory bodies, including the FDA and EMA, have shown increasing support through priority review pathways and conditional approvals, recognizing the need for long-term liver preservation strategies. As more therapies reach late-stage development, the PBC pipeline is poised to offer patients a better quality of life and liver-related outcomes.

Interested in learning more about the current treatment landscape and the key drivers shaping the primary biliary cholangitis pipeline? Click here: https://www.delveinsight.com/report-store/primary-biliary-cholangitis-pbc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Primary Biliary Cholangitis Pipeline Report
• DelveInsight's primary biliary cholangitis pipeline analysis depicts a strong space with 20+ active players working to develop 25+ pipeline drugs for primary biliary cholangitis treatment.
• The leading primary biliary cholangitis companies include Zydus Therapeutics, Calliditas Therapeutics, Hepagene, Dr Falk Pharma, Mirum Pharmaceuticals, GlaxoSmithKline, and others are evaluating their lead assets to improve the primary biliary cholangitis treatment landscape.
• Key primary biliary cholangitis pipeline therapies in various stages of development include Saroglitazar Magnesium, Setanaxib, HPG-1860, Norucholic acid, RhuDex, Volixibat, Linerixibat, and others.
• In June 2025, GSK plc (LSE/NYSE: GSK) announced the FDA has accepted the NDA for linerixibat, an IBAT inhibitor for treating cholestatic pruritus in primary biliary cholangitis (PBC). The PDUFA goal date is March 24, 2026.
• In January 2025, Cour Pharmaceuticals received orphan drug designation from the FDA for CNP-104, a treatment for primary biliary cholangitis (PBC).
• In December 2024, Gilead Sciences announced that the FDA granted accelerated approval for LIVDELZI (seladelpar) to treat primary biliary cholangitis (PBC). The drug is approved for use in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA or as a monotherapy for patients who cannot tolerate UDCA. However, Livdelzi is not recommended for individuals with or who develop decompensated cirrhosis.

Request a sample and discover the recent breakthroughs happening in the primary biliary cholangitis pipeline landscape at https://www.delveinsight.com/report-store/primary-biliary-cholangitis-pbc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Primary Biliary Cholangitis Overview
Primary Biliary Cholangitis (PBC) is a chronic, progressive autoimmune liver disease characterized by the gradual destruction of the small bile ducts within the liver. This damage leads to impaired bile flow (cholestasis), causing bile to accumulate and eventually resulting in liver inflammation, fibrosis, and potentially cirrhosis if untreated. PBC primarily affects middle-aged women and is often diagnosed through blood tests detecting specific antibodies, elevated liver enzymes, and imaging studies.

Symptoms of PBC can include fatigue, itching, dry eyes and mouth, and jaundice in advanced stages. While the exact cause is unknown, it is believed to involve a combination of genetic and environmental factors triggering an autoimmune response. Treatment focuses on slowing disease progression and managing symptoms, with ursodeoxycholic acid (UDCA) being the first-line therapy. For patients who do not respond to UDCA, additional medications like obeticholic acid may be used, and liver transplantation is considered in advanced cases.

Find out more about primary biliary cholangitis medication at https://www.delveinsight.com/report-store/primary-biliary-cholangitis-pbc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Primary Biliary Cholangitis Treatment Analysis: Drug Profile
Setanaxib: Calliditas Therapeutics
Setanaxib (GKT831) is a NOX1 and NOX4 inhibitor that has demonstrated anti-fibrotic effects in a Phase II clinical trial for primary biliary cholangitis (PBC), a rare liver disease. Following promising Phase II results, a Phase II/III trial for Setanaxib in PBC has been initiated. Additionally, Setanaxib is being investigated in Phase II trials led by investigators for Type 1 Diabetes with kidney disease (DKD) and idiopathic pulmonary fibrosis (IPF), a chronic lung condition characterized by fibrosis.

HPG-1860: Hepagene
HPG-1860, developed by Hepagene, is an oral drug candidate for the treatment of non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC). It is an avermectin derivative that works by targeting the farnesoid X receptor (FXR). HPG-1860 is currently in Phase I clinical development for PBC.

Learn more about the novel and emerging primary biliary cholangitis pipeline therapies at https://www.delveinsight.com/report-store/primary-biliary-cholangitis-pbc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Primary Biliary Cholangitis Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intravenous
• Subcutaneous
• Oral
• Intramuscular

By Molecule Type
• Monoclonal antibody
• Small molecule
• Peptide

Scope of the Primary Biliary Cholangitis Pipeline Report
• Coverage: Global
• Key Primary Biliary Cholangitis Companies: Zydus Therapeutics, Calliditas Therapeutics, Hepagene, Dr Falk Pharma, Mirum Pharmaceuticals, GlaxoSmithKline, and others.
• Key Primary Biliary Cholangitis Pipeline Therapies: Saroglitazar Magnesium, Setanaxib, HPG-1860, Norucholic acid, RhuDex, Volixibat, Linerixibat, and others.

To dive deep into rich insights for drugs used for primary biliary cholangitis treatment, visit: https://www.delveinsight.com/report-store/primary-biliary-cholangitis-pbc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Primary Biliary Cholangitis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Primary Biliary Cholangitis Pipeline Therapeutics
6. Primary Biliary Cholangitis Pipeline: Late-Stage Products (Phase III)
7. Primary Biliary Cholangitis Pipeline: Mid-Stage Products (Phase II)
8. Primary Biliary Cholangitis Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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This release was published on openPR.