Primary Biliary Cholangitis Clinical and Non-Clinical Studies, Key Companies, Therapeutic Assessment, Emerging Therapies, Treatment Algorithm, and Pipeline Analysis | Zydus Therapeutics, Calliditas Therapeutics, Hepagene, Calliditas Therapeutics, Dr Falk

Primary Biliary Cholangitis Pipeline constitutes 20+ key companies continuously working towards developing 25+ Primary Biliary Cholangitis treatment therapies, analyzes DelveInsight.

Primary Biliary Cholangitis Overview:

Primary Biliary Cholangitis (PBC) is a long-term autoimmune disease that gradually damages the small bile ducts in the liver, leading to bile buildup (cholestasis), liver damage, fibrosis, and eventually cirrhosis. The exact cause is unknown, but it mainly affects middle-aged women and is linked to genetic and environmental factors like infections or toxins.

In early stages, PBC may not cause symptoms, but as it progresses, fatigue, itching, and dry eyes or mouth often appear. Advanced disease can result in jaundice, dark urine, pale stools, and swelling due to fluid retention. Complications include vitamin deficiencies, osteoporosis, liver failure, and an increased risk of liver cancer.

PBC is believed to stem from an autoimmune reaction where the immune system mistakenly attacks bile ducts, possibly influenced by genetic predisposition and environmental triggers.

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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

DelveInsight's Primary Biliary Cholangitis pipeline report depicts a robust space with 20+ active players working to develop 25+ pipeline therapies for Primary Biliary Cholangitis treatment.
Key Primary Biliary Cholangitis companies such as Zydus Therapeutics, Calliditas Therapeutics, Hepagene, Calliditas Therapeutics, Dr Falk Pharma, Mirum Pharmaceuticals, GlaxoSmithKline, and others are evaluating new drugs for Primary Biliary Cholangitis to improve the treatment landscape.
Promising Primary Biliary Cholangitis pipeline therapies in various stages of development include Saroglitazar Magnesium, Setanaxib, HPG-1860, and others.

Recent breakthroughs in the Primary Biliary Cholangitis Pipeline Segment:
In November 2024, the FDA declined to grant full approval for Ocaliva as a treatment for PBC, following concerns about its clinical benefit. Subsequently, in December 2024, the FDA identified cases of serious liver injury associated with Ocaliva in patients without severe liver scarring. Healthcare professionals were advised to discontinue its use if liver disease progression is evident or if the drug's efficacy is not established.
Approved by the FDA in August 2024, seladelpar is indicated for PBC treatment. It functions as a peroxisome proliferator-activated receptor delta (PPARδ) receptor agonist.
In June 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to elafibranor for treating PBC in adults who have an inadequate response to ursodeoxycholic acid or cannot tolerate it. This approval was based on positive phase III ELATIVE trial data.

Primary Biliary Cholangitis Pipeline Analysis
The report provides insights into:
The report provides detailed insights into the key companies that are developing therapies in the Primary Biliary Cholangitis Market.
The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Primary Biliary Cholangitis treatment.
It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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.
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.

Download our free sample page report on Primary Biliary Cholangitis pipeline insights @ https://www.delveinsight.com/sample-request/primary-biliary-cholangitis-pbc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr

Primary Biliary Cholangitis Emerging Drugs

Saroglitazar Magnesium: Zydus Therapeutics
Setanaxib: Calliditas Therapeutics
HPG-1860: Hepagene

Primary Biliary Cholangitis Companies

Around 20 key companies are working on developing therapies for Primary Biliary Cholangitis (PBC). Among them, Zydus Therapeutics has a drug candidate in the most advanced stage of development, Phase III.

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

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

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

Intravenous
Subcutaneous
Oral
Intramuscular

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

Monoclonal antibody
Small molecule
Peptide

Download Sample Pages to Get an in-depth Assessment of the Emerging Primary Biliary Cholangitis Therapies and Key Companies: Primary Biliary Cholangitis Clinical Trials and advancements @ https://www.delveinsight.com/report-store/primary-biliary-cholangitis-pbc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr

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

Download Primary Biliary Cholangitis Sample report to know in detail about the Primary Biliary Cholangitis treatment market @ Primary Biliary Cholangitis Therapeutic Assessment @ https://www.delveinsight.com/sample-request/primary-biliary-cholangitis-pbc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr

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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Contact Info:
Kritika Rehani
krehani@delveinsight.com
info@delveinsight.com
+14699457679

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.

This release was published on openPR.