Primary Biliary Cholangitis Pipeline Set for Major Breakthroughs by 2026 with 25+ Therapies and Strong Clinical Momentum from GlaxoSmithKline, Novartis, and CymaBay Therapeutics | DelveInsight

Primary Biliary Cholangitis Pipeline

DelveInsight’s, “Primary Biliary Cholangitis Pipeline Insight 2026” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Primary Biliary Cholangitis pipeline landscape. It covers the Primary Biliary Cholangitis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Primary Biliary Cholangitis therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Primary Biliary Cholangitis Pipeline Report

• In March 2026, GSK finalized a late-stage agreement granting Alfasigma commercialization rights for linerixibat, an IBAT inhibitor currently under regulatory review globally for treating cholestatic pruritus in PBC. The deal includes an upfront payment of $300 million, with additional milestone-based payments tied to regulatory approvals and sales performance.
• February 2026: Across North America, Europe, and Asia Pacific, rising prevalence of autoimmune liver diseases and improved early diagnosis significantly accelerated demand for advanced PBC treatment options.
• January 2026: Globally, advancements in next-generation therapies such as FXR agonists, PPAR agonists, and immunomodulators enhanced treatment outcomes and addressed unmet needs beyond standard therapies like ursodeoxycholic acid (UDCA).
• In October 2025, Science 37 successfully completed its third FDA inspection of its Direct-to-Patient clinical trial site, receiving a No Action Indicated (NAI) rating. The inspection reviewed a Phase 3 primary biliary cholangitis study, where Science 37 enrolled 47% of U.S. patients, affirming quality, data integrity, and patient safety compliance.
• 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 June 2025, GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has accepted for review the NDA for linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter (IBAT), for the treatment of cholestatic pruritus in patients with PBC, a rare autoimmune liver disease. The Prescription Drug User Fee Act (PDUFA) goal date is 24 March 2026.
• In May 2025, Ipsen (Euronext: IPN; ADR: IPSEY) announced new data from two late-breaking presentations on IQIRVO® (elafibranor) during the European Association for the Study of the Liver congress. Late-breaking exploratory data highlights the impact of IQIRVO® (elafibranor) on fatigue and provides mechanistic insights into anti-inflammatory and symptom-related effects in patients with primary biliary cholangitis.
• In February 2025, Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Seladelpar (an orphan designated product) is now approved and will provide an important treatment option for people living with the rare liver disease in the European Economic Area (EEA).
• GlaxoSmithKline’s Linerixibat, an IBAT inhibitor currently in Phase III trials, targets the debilitating pruritus associated with PBC. Additionally, COUR Pharmaceuticals’ CNP-104 secured FDA Orphan Drug Designation in January 2025, positioning it as potentially the first disease-modifying treatment for PBC by inducing tolerance to pathogenic activated PDC-E2 T-cells that drive bile duct inflammation.
• In January 2025, COUR Pharmaceuticals, a clinical-stage biotech company focused on developing disease-modifying therapies for immune-mediated diseases, has received Orphan Drug Designation (ODD) from the FDA for CNP-104, a treatment for primary biliary cholangitis (PBC).
• In November 2024:- GlaxoSmithKline- This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study’s end or until linerixibat can be lawfully made available to participants.
• In November 2024:- Mirum Pharmaceuticals Inc.- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Biliary Cholangitis. The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.
• In November 2024:- Intercept Pharmaceuticals- A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid.
• DelveInsight’s Primary Biliary Cholangitis pipeline report depicts a robust space with 18+ active players working to develop 20+ pipeline therapies for Primary Biliary Cholangitis treatment.
• The leading Primary Biliary Cholangitis Companies such as Genfit, Zydus Discovery, Ohara Pharmaceutical, Chia Tai Tianqing Pharmaceutical Group Co. Ltd., Novartis, CymaBay Therapeutics, Calliditas Therapeutics, Hepagene, Calliditas Therapeutics, Dr Falk Pharma, Mirum Pharmaceuticals, GlaxoSmithKline, and others.
• Promising Primary Biliary Cholangitis Therapies such as Saroglitazar Magnesium 1 mg, Seladelpar 10 mg, Obeticholic Acid Tablets, and others.

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Primary Biliary Cholangitis Emerging Drugs Profile

Elafibranor: Genfit

Elafibranor is a dual agonist of the PPARα and PPARδ. Meaning the drug candidate acts simultaneously on the two nuclear receptors, which both play an important role in numerous processes involved in the development of NASH and its co-morbidities. It has shown highly significant results in its Phase 2 Study in patients with primary biliary cholangitis (PBC), while maintaining a favorable tolerability profile and lack of demonstrated safety concerns, paving the way for advancement into phase 3 clinical trial in 2020. It has recently been granted Breakthrough Therapy Designation by the FDA for the treatment of Primary Biliary Cholangitis (PBC) in adults with inadequate response to ursodeoxycholic acid (UDCA), as well as Orphan Drug Designation by the FDA and the EMA (European Medicines Agency).

ASC42: Gannex Pharma

ASC42 is a novel non-steroidal, selective, potent FXR agonist. It has shown positive results in its Phase I Study in patients with primary biliary cholangitis with no pruritus observed and LDL-C remained within normal range at the human therapeutic dose of 15 mg. The drug is in Phase II stage of its clinical studies for Primary Biliary Cholangitis.

OP-724: Ohara Pharmaceutical

OP-724 is a synthetic small molecule which is an inhibitor of cyclic AMP response element-binding protein (CREB)-binding protein (CBP)/β-catenin. Ohara Pharmaceutical obtained development rights for OP-724 from PRISM BioLab in 2018. The drug is in Phase I stage of its clinical studies for Primary Biliary Cholangitis.

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Primary Biliary Cholangitis Companies

There are approx. 20+ key companies which are developing the therapies for Primary Biliary Cholangitis (PBC). The companies which have their Primary Biliary Cholangitis (PBC) drug candidates in the most advanced stage, i.e. Phase III include, Zydus Therapeutics.

Primary Biliary Cholangitis Phases of Drugs

DelveInsight’s report covers around 25+ products under different phases of clinical development like

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

Primary Biliary Cholangitis by Route of Administration

Primary Biliary Cholangitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Primary Biliary Cholangitis Products have been categorized under various Molecule types such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

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Scope of the Primary Biliary Cholangitis Pipeline Report

• Coverage- Global
• Primary Biliary Cholangitis Companies- Gilead Sciences (NASDAQ: GILD), Intercept Pharmaceuticals (NASDAQ: ICPT), CymaBay Therapeutics (NASDAQ: CBAY), COUR Pharmaceuticals, Teva Pharmaceutical (NYSE: TEVA), Mylan, AbbVie (NYSE: ABBV), Glenmark Pharmaceuticals (NSE: GLENMARK), Allergan, Eli Lilly (NYSE: LLY), Novartis (NYSE: NVS), Pfizer (NYSE: PFE), Roche (SWX: ROG), Merck (NYSE: MRK), Bristol-Myers Squibb (NYSE: BMY), AstraZeneca (NASDAQ: AZN), GlaxoSmithKline (NYSE: GSK), Takeda (NYSE: TAK), Amgen (NASDAQ: AMGN), Boehringer Ingelheim, Dr. Reddy’s (NYSE: RDY), Amneal (NASDAQ: AMRX), Alnylam (NASDAQ: ALNY), Ionis (NASDAQ: IONS), Arrowhead (NASDAQ: ARWR), CureVac (NASDAQ: CVAC), Sangamo (NASDAQ: SGMO), Calliditas Therapeutics (NASDAQ: CALT), NGM Biopharmaceuticals (NASDAQ: NGM), Bluebird Bio (NASDAQ: BLUE), Intellia (NASDAQ: NTLA), Albireo, TARGET PharmaSolutions, Genfit (NASDAQ: GNFT), and Ascletis Pharma, among others.
• Primary Biliary Cholangitis Therapies- Saroglitazar Magnesium 1 mg, Seladelpar 10 mg, Obeticholic Acid Tablets, and others.
• Primary Biliary Cholangitis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Primary Biliary Cholangitis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

For a detailed overview of our latest research findings and future plans, read the full details of Primary Biliary Cholangitis Pipeline on our website @ Primary Biliary Cholangitis Drugs and Companies

Table of Content

1. Introduction

2. Executive Summary

3. Primary Biliary Cholangitis: Overview

4. Pipeline Therapeutics

5. Therapeutic Assessment

6. Primary Biliary Cholangitis – DelveInsight’s Analytical Perspective

7. Late Stage Products (Phase III)

8. Elafibranor: Genfit

9. Drug profiles in the detailed report…..

10. Mid Stage Products (Phase II)

11. ASC42: Gannex Pharma

12. Drug profiles in the detailed report…..

13. Early Stage Products (Phase I)

14. OP-724: Ohara Pharmaceutical

15. Drug profiles in the detailed report…..

16. Inactive Products

17. Primary Biliary Cholangitis Key Companies

18. Primary Biliary Cholangitis Key Products

19. Primary Biliary Cholangitis- Unmet Needs

20. Primary Biliary Cholangitis- Market Drivers and Barriers

21. Primary Biliary Cholangitis- Future Perspectives and Conclusion

22. Primary Biliary Cholangitis Analyst Views

23. Primary Biliary Cholangitis Key Companies

24. Appendix

About DelveInsight

DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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