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Primary Biliary Cirrhosis - Pipeline Insight, 2021

March 2021 | 60 pages | ID: PB4CCE22175EN
DelveInsight

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DelveInsight’s, “Primary Biliary Cirrhosis - Pipeline Insight, 2021,” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Primary Biliary Cirrhosis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered
  • Global coverage
Primary Biliary Cirrhosis Understanding

Primary Biliary Cirrhosis: Overview

Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disease predominantly affecting middle-aged women. It is hypothesized that PBC begins with loss of immune self tolerance, leading to damage of the biliary epithelial cells of small bile ducts. Ongoing immunologic events perpetuate the biliary epithelial cell destruction via direct cytotoxicity or lymphokine-mediated cell damage, leading to disease progression. PBC is most commonly diagnosed after the age of 40 years. Of patients with PBC, 90% are women

'Primary Biliary Cirrhosis - Pipeline Insight, 2021' report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Primary Biliary Cirrhosis pipeline landscape is provided which includes the disease overview and Primary Biliary Cirrhosis treatment guidelines. The assessment part of the report embraces, in depth Primary Biliary Cirrhosis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Primary Biliary Cirrhosis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights
  • The companies and academics are working to assess challenges and seek opportunities that could influence Primary Biliary Cirrhosis R&D. The therapies under development are focused on novel approaches to treat/improve Primary Biliary Cirrhosis.
Primary Biliary Cirrhosis Emerging Drugs Chapters

This segment of the Primary Biliary Cirrhosis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Primary Biliary Cirrhosis Emerging Drugs
  • Seladelpar: CymaBay Therapeutics
Seladelpar (MBX-8025) is a potent, selective, orally active peroxisome proliferator-activated receptor ? (PPAR?) agonist in development for the treatment of patients with the autoimmune liver disease, primary biliary cholangitis (PBC). Seladelpar is uniquely suited as a potential treatment for inflammatory liver diseases. In the liver, PPAR? is expressed in multiple cell types including: hepatocytes, cholangiocytes, Kupffer cells and stellate cells. Preclinical and clinical data support its effect on regulating genes involved in bile acids synthesis, inflammation, fibrosis and lipid metabolism, storage and transport. The drug is currently in phase 3 of clinical trials for the treatment of Primary Biliary Cirrhosis.
  • Maralixibat: Mirum Pharmaceuticals
Maralixibat is an orally administered investigational drug being evaluated in several rare cholestatic liver diseases for both pediatric and adult populations. Maralixibat inhibits the apical sodium dependent bile acid transporter (ASBT), thereby preventing bile acids from accumulating in the liver. The drug is currently in phase 2 of clinical trials for the treatment of Primary Biliary Cirrhosis.

Further product details are provided in the report……..

Primary Biliary Cirrhosis: Therapeutic Assessment

This segment of the report provides insights about the different Primary Biliary Cirrhosis drugs segregated based on following parameters that define the scope of the report, such as:
  • Major Players in Primary Biliary Cirrhosis
There are approx. 5+ key companies which are developing the therapies for Primary Biliary Cirrhosis. The companies which have their Primary Biliary Cirrhosis drug candidates in the mid to advanced stage, i.e. phase III include, CymaBay Therapeutics and others.

Phases

DelveInsight’s report covers around 5+ products under different phases of clinical development like
  • Late-stage products (phase III)
  • Mid-stage products (Phase II and Phase I/II)
  • Early-stage products (Phase I/II and Phase I) along with the details of
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates
  • 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
  • Subcutaneous
  • Intravenous
  • Oral
  • Intramuscular
  • Molecule Type
Products have been categorized under various Molecule types such as
  • Small molecules
  • Natural metabolites
  • Monoclonal antibodies
  • Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Primary Biliary Cirrhosis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Primary Biliary Cirrhosis therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Primary Biliary Cirrhosis drugs.

Primary Biliary Cirrhosis Report Insights
  • Primary Biliary Cirrhosis Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs
Primary Biliary Cirrhosis Report Assessment
  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Inactive drugs assessment
  • Unmet Needs
Key Questions

Current Treatment Scenario and Emerging Therapies:
  • How many companies are developing Primary Biliary Cirrhosis drugs?
  • How many Primary Biliary Cirrhosis drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Primary Biliary Cirrhosis?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Primary Biliary Cirrhosis therapeutics?
  • What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Primary Biliary Cirrhosis and their status?
  • What are the key designations that have been granted to the emerging drugs?
Key Players
  • CymaBay Therapeutics
  • Mirum Pharmaceuticals
  • MYR Pharma
  • Incyte Corporation
  • Chia Tai Tianqing Pharmaceutical Group
Key Products
  • Seladelpar
  • Maralixibat
  • Bulevirtide
  • Baricitinib
  • TQA3526
Introduction
Executive Summary
Primary Biliary Cirrhosis: Overview
• Causes
• Mechanism of Action
• Signs and Symptoms
• Diagnosis
• Disease Management
Pipeline Therapeutics
• Comparative Analysis
Therapeutic Assessment
• Assessment by Product Type
• Assessment by Stage and Product Type
• Assessment by Route of Administration
• Assessment by Stage and Route of Administration
• Assessment by Molecule Type
• Assessment by Stage and Molecule Type
Primary Biliary Cirrhosis – DelveInsight’s Analytical Perspective
In-depth Commercial Assessment
• Primary Biliary Cirrhosis companies’ collaborations, Licensing, Acquisition -Deal Value Trends
Primary Biliary Cirrhosis Collaboration Deals
• Company-Company Collaborations (Licensing / Partnering) Analysis
• Company-University Collaborations (Licensing / Partnering) Analysis
Late Stage Products (Phase III)
• Comparative Analysis
Seladelpar: CymaBay Therapeutics
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
• Comparative Analysis
Maralixibat: Mirum Pharmaceuticals
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
• Comparative Analysis
Primary Biliary Cirrhosis Key Companies
Primary Biliary Cirrhosis Key Products
Primary Biliary Cirrhosis- Unmet Needs
Primary Biliary Cirrhosis- Market Drivers and Barriers
Primary Biliary Cirrhosis- Future Perspectives and Conclusion
Primary Biliary Cirrhosis Analyst Views
Primary Biliary Cirrhosis Key Companies
Appendix

LIST OF TABLES

Table 1 Total Products for Primary Biliary Cirrhosis
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products


LIST OF FIGURES

Figure 1 Total Products for Primary Biliary Cirrhosis
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products


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