(Albany, USA) DelveInsight’s, “Primary Biliary Cholangitis Pipeline Insight 2025” report provides comprehensive insights about 18+ companies and 20+ 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 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, 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 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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