Primary Biliary Cholangitis Pipeline Drugs Report 2025: Transformative Research, Competitive Landscape, and Future Treatment Prospects
DelveInsight’s, “Primary Biliary Cholangitis Pipeline Insight 2025” 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 pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Curious about the latest updates in the Primary Biliary Cholangitis Pipeline? Click here to explore the therapies and trials making headlines @ Primary Biliary Cholangitis Pipeline Outlook Report
Key Takeaways from the Primary Biliary Cholangitis Pipeline Report
- On 12 September 2025, Gilead Sciences conducted a study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
- On 10 September 2025, Kowa Research Institute Inc. announced a Phase 2 Multicenter 12-week Study With a 52-week Extension to Evaluate the Efficacy and Safety of Two Doses of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Inadequate Response to Ursodeoxycholic Acid and/or Obeticholic Acid Treatment.
- 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.
- The leading Primary Biliary Cholangitis Companies such as Zydus Therapeutics, Calliditas Therapeutics, Hepagene, Dr Falk Pharma, Mirum Pharmaceuticals, GlaxoSmithKline and others.
- Promising Primary Biliary Cholangitis Therapies such as Saroglitazar Magnesium 1 mg, Seladelpar, ASC42 5 mg, Elafibranor, Obeticholic Acid Tablets, Bezafibrate 100 mg, Obeticholic Acid 5 mg and others.
Want to know which companies are leading innovation in Primary Biliary Cholangitis? Dive into the full pipeline insights @ Primary Biliary Cholangitis Clinical Trials Assessment
The Primary Biliary Cholangitis Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The Primary Biliary Cholangitis Pipeline Report also highlights the unmet needs with respect to the Primary Biliary Cholangitis.
Primary Biliary Cholangitis Overview
Primary Biliary Cholangitis (PBC) is a chronic, progressive autoimmune disease that primarily affects the bile ducts in the liver. It leads to inflammation and gradual destruction of the small bile ducts, causing bile to accumulate in the liver (cholestasis). Over time, this can result in liver damage, fibrosis, and eventually cirrhosis. Although the exact cause of PBC remains unclear, it predominantly affects middle-aged women and is considered an autoimmune disorder. Genetic and environmental factors, such as infections or toxic exposures, may contribute to its onset.
Primary Biliary Cholangitis (PBC) Emerging Drugs
- Saroglitazar Magnesium: Zydus Therapeutics
Saroglitazar (LIPAGLYN) contains two main classes of PPAR agonists, which include PPARα (alpha) and PPARγ (gamma). The drug has lipid and glucose-lowering effects in a single molecule; it lowers high blood triglycerides and blood sugar and improves insulin resistance. The drug is available in tablet form of 4 mg dose for oral administration. Saroglitazar is indicated for treating diabetic dyslipidemia and hypertriglyceridemia with type 2 diabetes mellitus not controlled by statin therapy. In clinical studies, saroglitazar has demonstrated a reduction of triglycerides (TG), LDL cholesterol, VLDL cholesterol, and non-HDL cholesterol and an increase in HDL cholesterol, a characteristic hallmark of atherogenic diabetic dyslipidemia (ADD). The US FDA has granted ODD and FTD to saroglitazar Mg for PBC. It is currently being investigated in Phase III stage of clinical development for the treatment of Primary Biliary Cholangitis.
- Setanaxib: Calliditas Therapeutics
Setanaxib (GKT831), a NOX1 and NOX4 inhibitor, has shown evidence of anti-fibrotic activity in a Phase II clinical trial in primary biliary cholangitis (PBC, an orphan liver disease). Based on its Phase II results, a phase II/III trial with Setanaxib in PBC was initiated. Setanaxib is also being evaluated in an investigator-initiated Phase II clinical trial in Type 1 Diabetes and Kidney Disease (DKD) as well as being studied in an investigator led Phase II clinical trial in idiopathic pulmonary fibrosis (IPF), a chronic lung disease that results in fibrosis of the lungs. Currently the drug is in Phase II stage of its development for the treatment of Primary biliary cholangitis.
- HPG-1860: Hepagene
HPG-1860 is under development for the treatment of non-alcoholic steatohepatitis (NASH), Primary Biliary Cholangitis. It is administered by oral route. The drug candidate is an avermectin derivative and acts by targeting farnesoid X activated receptor. The drug is currently in phase I stage of development for the treatment of PBC. The drug is currently in Phase I stage of its clinical development for the study of Primary Biliary Cholangitis (PBC).
If you’re tracking ongoing Primary Biliary Cholangitis Clinical trials, this press release is a must-read. Tap to see the breakthroughs @ Primary Biliary Cholangitis Treatment Drugs
Primary Biliary Cholangitis Companies
Zydus Therapeutics, Calliditas Therapeutics, Hepagene, Dr Falk Pharma, Mirum Pharmaceuticals, GlaxoSmithKline and others.
Primary Biliary Cholangitis (PBC) 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
From emerging drug candidates to competitive intelligence, the Primary Biliary Cholangitis Pipeline Report covers it all – check it out now @ Primary Biliary Cholangitis Market Drivers and Barriers, and Future Perspectives
Scope of the Primary Biliary Cholangitis Pipeline Report
- Coverage- Global
- Primary Biliary Cholangitis Companies- Zydus Therapeutics, Calliditas Therapeutics, Hepagene, Dr Falk Pharma, Mirum Pharmaceuticals, GlaxoSmithKline and others.
- Primary Biliary Cholangitis Therapies- Saroglitazar Magnesium 1 mg, Seladelpar, ASC42 5 mg, Elafibranor, Obeticholic Acid Tablets, Bezafibrate 100 mg, Obeticholic Acid 5 mg 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
Stay ahead in Healthcare Research – discover what’s next for the Primary Biliary Cholangitis treatment landscape in this detailed analysis @ Primary Biliary Cholangitis Emerging Drugs and Major Players
Table of Contents
- Introduction
- Executive Summary
- Primary Biliary Cholangitis (PBC): Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Primary Biliary Cholangitis (PBC)– DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- Saroglitazar Magnesium: Zydus Therapeutics
- Mid Stage Products (Phase II)
- Setanaxib: Calliditas Therapeutics
- Early Stage Products (Phase I)
- HPG-1860: Hepagene
- Preclinical and Discovery Stage Products
- Drug Name: Company Name
- Inactive Products
- Primary Biliary Cholangitis (PBC) Key Companies
- Primary Biliary Cholangitis (PBC) Key Products
- Primary Biliary Cholangitis (PBC)- Unmet Needs
- Primary Biliary Cholangitis (PBC)- Market Drivers and Barriers
- Primary Biliary Cholangitis (PBC)- Future Perspectives and Conclusion
- Primary Biliary Cholangitis (PBC) Analyst Views
- Primary Biliary Cholangitis (PBC) Key Companies
- Appendix
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