DelveInsight’s, “Primary Biliary Cholangitis Pipeline Insight 2024” 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

• June 2024:- Zydus Therapeutics Inc.- A Multicenter, Open-Label, Extension Clinical Trial to Evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis (PBC). A Multicenter, Open-Label, Extension Clinical trial to evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis (PBC).
• June 2024:- CymaBay Therapeutics Inc.- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis. To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
• June 2024:- COUR Pharmaceuticals Development Company Inc.- A Phase 2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-104 in Subjects Ages 18-75 With Primary Biliary Cholangitis Who Are Unresponsive to UDCA and/or OCA. This study is a Phase 2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-104. The study consists of a 120 day primary study followed by a 20 month long-term safety and durability of response follow-up period.
• June 2024:- Calliditas Therapeutics Suisse SA– The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).
• June 2024:- Ipsen– A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis (PSC). This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to injury and destruction of bile ducts.
• June 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 Sclerosing 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 Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.
• June 2024:- GlaxoSmithKline– A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC). This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.
• 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- Genfit, Zydus Discovery, Ohara Pharmaceutical, Chia Tai Tianqing Pharmaceutical Group Co. Ltd., Novartis, CymaBay Therapeutics, and 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

 

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