Primary Biliary Cirrhosis Pipeline Drugs Analysis Report, 2023: FDA Approvals, Clinical Trials, Therapies, MOA, ROA by DelveInsight | PRISM Pharma Co, Albireo Pharma, Pliant Therapeutics, GentiBio

The Primary Biliary Cirrhosis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

“Primary Biliary Cirrhosis Pipeline Insight, 2023“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Primary Biliary Cirrhosis Market.

Some of the key takeaways from the Primary Biliary Cirrhosis Pipeline Report:

• Companies across the globe are diligently working toward developing novel Primary Biliary Cirrhosis treatment therapies with a considerable amount of success over the years. 
• Primary Biliary Cirrhosis companies working in the treatment market are Parvus Therapeutics, Selecta Biosciences, Hepagene Therapeutics, Ohara Pharmaceutical, Cour Pharmaceutical, Umecrine Cognition, Mirum Pharmaceuticals, Gannex Pharma, Dr Falk Pharma, Genfit, CymaBay Therapeutics, and others, are developing therapies for the Primary Biliary Cirrhosis treatment 

• Emerging Primary Biliary Cirrhosis therapies in the different phases of clinical trials are- PVT-201, PDC-E2, HPG-1860, OP-724, CNP-104, Golexanolone, Volixibat, ASC42, Norucholic acid, Elafibranor, Seladelpar, and others are expected to have a significant impact on the Primary Biliary Cirrhosis market in the coming years.   
• In January 2023, CymaBay Therapeutics, Inc. has disclosed a collaboration and licensing pact with Kaken Pharmaceutical Co., Ltd. This agreement pertains to the development and commercialization of CymaBay’s experimental drug seladelpar intended for treating primary biliary cholangitis in Japan. As per the terms, Kaken obtains an exclusive license to handle the development, marketing, and sales of seladelpar specifically for Primary Biliary Cirrhosis within Japan.
• In August 2022, Gannex Pharma Co., Ltd., a subsidiary of Ascletis Pharma Inc., has completed the initial dosing phase in the United States for its drug-drug interaction (DDI) study of ASC42, a Farnesoid X Receptor agonist used in treating primary biliary cholangitis (PBC). Simultaneously, the DDI study conducted alongside an ongoing phase II clinical trial for PBC patients in China aims to gather additional data supporting forthcoming phase III trials scheduled in the United States, China, and the European Union.
• In July 2022, CymaBay disclosed that the FDA has removed the clinical holds imposed on seladelpar for all three Investigational New Drug (IND) applications related to Nonalcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC), and Primary Sclerosing Cholangitis (PSC). Initially, in November 2019, the FDA had placed holds on all active INDs for seladelpar due to unusual histological findings noted in the Phase II NASH study, despite the absence of identified clinical or laboratory correlations.
• GENFIT is presently assessing its in-house developed drug candidate, elafibranor, acting as a dual agonist for PPARα and PPARδ in Primary Biliary Cholangitis (PBC). The Phase III clinical trial ELATIVE (NCT04526665) is actively enrolling participants, aiming to validate the efficacy of elafibranor at 80mg by assessing alterations in biochemical parameters. Additionally, the trial seeks to explore its potential in alleviating pruritus while ensuring patient safety in PBC cases. Elafibranor secured Breakthrough Therapy designation from the FDA in April 2019 for treating PBC in adults with insufficient response to UDCA. Moreover, it received Orphan Drug Designation from both the FDA and the EMA (European Medicines Agency) in July 2019. In November 2022, GENFIT announced the anticipated release of Phase III data for elafibranor in primary biliary cholangitis (PBC) expected by the second quarter of 2023.
• CNP-104 is a product in development that utilizes Cour’s nanoparticle platform (CNP), an innovative proprietary system. This technology merges disease-specific pathogenic antigens with advanced pharmaceutical nanoparticles designed to mimic the body’s natural elimination of deceased or dying cells. Cour’s platform has demonstrated its technological effectiveness in both clinical and preclinical settings. COUR is currently conducting a clinical study, with anticipated top-line data to be available in 2023. In January 2022, the US Food and Drug Administration (FDA) granted Fast Track designation to CNP-104 for addressing primary biliary cholangitis (PBC).

Primary Biliary Cirrhosis Overview

Primary biliary cirrhosis (PBC) is an autoimmune-related, chronic liver condition characterized by a gradual and persistent cholestatic disease. It involves damage to the bile ducts within the liver, potentially progressing to liver failure. Typically diagnosed in individuals between their fifth to seventh decades of life, this condition primarily affects women, constituting about 90% of cases.

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Emerging Primary Biliary Cirrhosis Drugs Under Different Phases of Clinical Development Include:

• PVT-201: Parvus Therapeutics
• PDC-E2: Selecta Biosciences
• HPG-1860: Hepagene Therapeutics
• OP-724: Ohara Pharmaceutical
• CNP-104: Cour Pharmaceutical
• Golexanolone: Umecrine Cognition
• Volixibat: Mirum Pharmaceuticals
• ASC42: Gannex Pharma
• Norucholic acid: Dr Falk Pharma
• Elafibranor: Genfit
• Seladelpar: CymaBay Therapeutics

Primary Biliary Cirrhosis Route of Administration

Primary Biliary Cirrhosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as 

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Primary Biliary Cirrhosis Molecule Type

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

• Oligonucleotide
• Peptide
• Small molecule

Primary Biliary Cirrhosis Pipeline Therapeutics Assessment

• Primary Biliary Cirrhosis Assessment by Product Type
• Primary Biliary Cirrhosis By Stage and Product Type
• Primary Biliary Cirrhosis Assessment by Route of Administration
• Primary Biliary Cirrhosis By Stage and Route of Administration
• Primary Biliary Cirrhosis Assessment by Molecule Type
• Primary Biliary Cirrhosis by Stage and Molecule Type

DelveInsight’s Primary Biliary Cirrhosis 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)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Primary Biliary Cirrhosis product details are provided in the report. Download the Primary Biliary Cirrhosis pipeline report to learn more about the emerging Primary Biliary Cirrhosis therapies

Some of the key companies in the Primary Biliary Cirrhosis Therapeutics Market include:

Key companies developing therapies for Primary Biliary Cirrhosis are – PRISM Pharma Co, Albireo Pharma, Pliant Therapeutics, GentiBio, Gannex Pharma, Selecta Biosciences, Intercept Pharmaceuticals, Umecrine Cognition, Genfit, CymaBay Therapeutics, Calliditas Therapeutics, Zydus-Cadila, Cour Pharmaceutical, Mirum Pharmaceuticals, HighTide Biopharma, Suzhou Zelgen Biopharmaceuticals, Merck Sharp & Dohme LLC, Kowa Pharmaceuticals, and others.

Primary Biliary Cirrhosis Pipeline Analysis:

The Primary Biliary Cirrhosis pipeline report provides insights into 

• The report provides detailed insights about companies that are developing therapies for the treatment of Primary Biliary Cirrhosis with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Primary Biliary Cirrhosis Treatment.
• Primary Biliary Cirrhosis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Primary Biliary Cirrhosis 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 Cirrhosis market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

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Primary Biliary Cirrhosis Pipeline Market Drivers

• Increasing Cases of Primary Biliary Cirrhosis, increasing demand for effective treatment, increasing drug pipeline and FDA approval are some of the important factors that are fueling the Primary Biliary Cirrhosis Market.

Primary Biliary Cirrhosis Pipeline Market Barriers

• However, high cost of the treatment, challenging clinical trial study, lacking consensus stratification protocol to identify patients for second line treatment and other factors are creating obstacles in the Primary Biliary Cirrhosis Market growth.

Scope of Primary Biliary Cirrhosis Pipeline Drug Insight    

• Coverage: Global
• Key Primary Biliary Cirrhosis Companies: Parvus Therapeutics, Selecta Biosciences, Hepagene Therapeutics, Ohara Pharmaceutical, Cour Pharmaceutical, Umecrine Cognition, Mirum Pharmaceuticals, Gannex Pharma, Dr Falk Pharma, Genfit, CymaBay Therapeutics, and others
• Key Primary Biliary Cirrhosis Therapies: PVT-201, PDC-E2, HPG-1860, OP-724, CNP-104, Golexanolone, Volixibat, ASC42, Norucholic acid, Elafibranor, Seladelpar, and others
• Primary Biliary Cirrhosis Therapeutic Assessment: Primary Biliary Cirrhosis current marketed and Primary Biliary Cirrhosis emerging therapies
• Primary Biliary Cirrhosis Market Dynamics: Primary Biliary Cirrhosis market drivers and Primary Biliary Cirrhosis market barriers 

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Table of Contents

1. Primary Biliary Cirrhosis Report Introduction

2. Primary Biliary Cirrhosis Executive Summary

3. Primary Biliary Cirrhosis Overview

4. Primary Biliary Cirrhosis- Analytical Perspective In-depth Commercial Assessment

5. Primary Biliary Cirrhosis Pipeline Therapeutics

6. Primary Biliary Cirrhosis Late Stage Products (Phase II/III)

7. Primary Biliary Cirrhosis Mid Stage Products (Phase II)

8. Primary Biliary Cirrhosis Early Stage Products (Phase I)

9. Primary Biliary Cirrhosis Preclinical Stage Products

10. Primary Biliary Cirrhosis Therapeutics Assessment

11. Primary Biliary Cirrhosis Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Primary Biliary Cirrhosis Key Companies

14. Primary Biliary Cirrhosis Key Products

15. Primary Biliary Cirrhosis Unmet Needs

16 . Primary Biliary Cirrhosis Market Drivers and Barriers

17. Primary Biliary Cirrhosis Future Perspectives and Conclusion

18. Primary Biliary Cirrhosis Analyst Views

19. Appendix

20. About DelveInsight

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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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