According to DelveInsight, the Primary Biliary Cholangitis (PBC) pipeline includes over 20 leading companies actively developing more than 25 therapeutic candidates for the treatment of PBC.
Primary Biliary Cholangitis Overview:
Primary Biliary Cholangitis (PBC) is a chronic autoimmune disorder that progressively damages the small bile ducts in the liver, causing bile accumulation (cholestasis), liver injury, fibrosis, and eventually cirrhosis. While the exact cause remains unclear, the disease predominantly affects middle-aged women and is associated with genetic factors and environmental triggers such as infections or toxins.
In its early stages, PBC may be asymptomatic, but as the disease advances, common symptoms include fatigue, itching, and dryness of the eyes or mouth. In more severe cases, patients may experience jaundice, dark urine, pale stools, and fluid-related swelling. Potential complications include vitamin deficiencies, osteoporosis, liver failure, and an elevated risk of liver cancer.
The condition is thought to result from an autoimmune response in which the immune system mistakenly attacks the bile ducts, with both genetic predisposition and environmental factors likely contributing to disease development.
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"Primary Biliary Cholangitis Pipeline Insight 2025" report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Primary Biliary Cholangitis Therapeutics Market.
Key Takeaways from the Primary Biliary Cholangitis Pipeline Report
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DelveInsight’s Primary Biliary Cholangitis (PBC) pipeline report highlights a dynamic landscape, with over 20 active companies developing more than 25 therapeutic candidates for PBC treatment.
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Key players—including Zydus Therapeutics, Calliditas Therapeutics, Hepagene, Dr Falk Pharma, Mirum Pharmaceuticals, GlaxoSmithKline, and others—are actively exploring new therapies to enhance the PBC treatment landscape. Notable pipeline candidates in various stages of development include Saroglitazar Magnesium, Setanaxib, HPG-1860, and others.
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In November 2024, the FDA declined full approval for Ocaliva as a PBC treatment due to concerns over its clinical benefit. By December 2024, the FDA reported cases of serious liver injury in patients without severe liver scarring, advising healthcare professionals to discontinue use if disease progression is evident or if the drug’s efficacy is unproven.
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Seladelpar received FDA approval in August 2024 for PBC treatment and acts as a peroxisome proliferator-activated receptor delta (PPARδ) agonist.
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In June 2024, the FDA granted accelerated approval to elafibranor for adults with PBC who have an inadequate response to ursodeoxycholic acid or cannot tolerate it, based on positive results from the Phase III ELATIVE trial.
Primary Biliary Cholangitis Pipeline Analysis
The report provides insights into:
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The report provides detailed insights into the key companies that are developing therapies in the Primary Biliary Cholangitis Market.
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The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Primary Biliary Cholangitis treatment.
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It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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It navigates the emerging drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement, and financing details for future advancement of the Primary Biliary Cholangitis market.
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Primary Biliary Cholangitis Emerging Drugs
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Saroglitazar Magnesium: Zydus Therapeutics
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Setanaxib: Calliditas Therapeutics
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HPG-1860: Hepagene
Primary Biliary Cholangitis Companies
Approximately 20 leading companies are actively developing therapies for Primary Biliary Cholangitis (PBC), with Zydus Therapeutics having a drug candidate currently in the most advanced stage of development, Phase III.
DelveInsight’s report covers around 25+ products under different phases of clinical development like
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Late stage products (Phase III)
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Mid-stage products (Phase II)
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Early-stage product (Phase I) along with the details of
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Pre-clinical and Discovery stage candidates
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Discontinued & Inactive candidates
Primary Biliary Cholangitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
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Intravenous
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Subcutaneous
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Oral
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Intramuscular
Primary Biliary Cholangitis Products have been categorized under various Molecule types such as
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Monoclonal antibody
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Small molecule
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Peptide
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Primary Biliary Cholangitis Pipeline Therapeutic Assessment
• Primary Biliary Cholangitis Assessment by Product Type
• Primary Biliary Cholangitis By Stage
• Primary Biliary Cholangitis Assessment by Route of Administration
• Primary Biliary Cholangitis Assessment by Molecule Type
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Table of Content
1. Report Introduction
2. Executive Summary
3. Primary Biliary Cholangitis Current Treatment Patterns
4. Primary Biliary Cholangitis - DelveInsight's Analytical Perspective
5. Therapeutic Assessment
6. Primary Biliary Cholangitis Late-Stage Products (Phase-III)
7. Primary Biliary Cholangitis Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Primary Biliary Cholangitis Discontinued Products
13. Primary Biliary Cholangitis Product Profiles
14. Primary Biliary Cholangitis Key Companies
15. Primary Biliary Cholangitis Key Products
16. Dormant and Discontinued Products
17. Primary Biliary Cholangitis Unmet Needs
18. Primary Biliary Cholangitis Future Perspectives
19. Primary Biliary Cholangitis Analyst Review
20. Appendix
21. Report Methodology
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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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