This “Primary Biliary Cholangitis - Pipeline Insight, 2021,” report provides comprehensive insights about 28+ companies and 28+ pipeline drugs in Primary Biliary Cholangitis 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.
Primary Biliary cholangitis (PBC), previously called primary biliary cirrhosis, is a chronic liver disease resulting from progressive destruction of the bile ducts in the liver. The common symptoms of primary biliary cholangitis are feeling tired and having itchy skin. Many people have no symptoms when they are first diagnosed. Women are nine times more likely than men to develop PBC. The diagnosis of primary biliary cirrhosis is done based upon patient history and physical examination. Liver function tests, blood test, ultrasound, CT scan, and/or MRI are done to confirm the diagnosis. Ursodiol (Actigal) or ursodeoxycholic acid (UDCA) is the first line of treatment for PBC. Intense itching is one of the most common symptoms of PBC. Over-the-counter antihistamines like diphenhydramine (Benadryl) may be helpful. Other agents such as rifampicin, naltrexone, cholestyramine and sertraline may also be prescribed.
"Primary Biliary Cholangitis - Pipeline Insight, 2021" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Primary Biliary Cholangitis pipeline landscape is provided which includes the disease overview and Primary Biliary Cholangitis treatment guidelines. The assessment part of the report embraces, in depth Primary Biliary Cholangitis 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 Cholangitis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
The companies and academics are working to assess challenges and seek opportunities that could influence Primary Biliary Cholangitis R&D. The therapies under development are focused on novel approaches to treat/improve Primary Biliary Cholangitis.
This segment of the Primary Biliary Cholangitis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, 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.
Elafibranor: Genfit
Elafibranor (GFT505) is an agonist of the peroxisome proliferator-activated receptor-a and peroxisome proliferator-activated receptor-d. Elafibranor was granted Breakthrough Therapy designation by the FDA in April 2019 for the treatment of PBC in adults with inadequate response to UDCA, as well as Orphan Drug Designation by the FDA and the EMA (European Medicines Agency) in July 2019. The drug is in Phase III clinical development for the treatment of Primary Biliary Cholangitis (PBC).
Seladelpar: CymaBay Therapeutics
Seladelpar (MBX-8025) is a potent, selective, orally active peroxisome proliferator-activated receptor d (PPARd) agonist. In February 2019, the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to seladelpar for the treatment of early-stage primary biliary cholangitis (PBC). The drug is in clinical development for the treatment of primary biliary cholangitis (PBC), primary sclerosing cholangitis, and non-alcoholic steatohepatitis.
There are approx. 28+ key companies which are developing the therapies for Primary Biliary Cholangitis. The companies which have their Primary Biliary Cholangitis drug candidates in the most advanced stage, i.e. Phase III include, Genfit.
The drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
The report provides insights into different therapeutic candidates in phase III, II, I, preclinical and discovery stage. It also analyses Primary Biliary Cholangitis therapeutic drugs key players involved in developing key drugs.
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Primary Biliary Cholangitis drugs.
Research programme: AAV-based gene therapies
Geography Covered
- Global coverage
Primary Biliary Cholangitis Understanding
Primary Biliary Cholangitis: Overview
Primary Biliary cholangitis (PBC), previously called primary biliary cirrhosis, is a chronic liver disease resulting from progressive destruction of the bile ducts in the liver. The common symptoms of primary biliary cholangitis are feeling tired and having itchy skin. Many people have no symptoms when they are first diagnosed. Women are nine times more likely than men to develop PBC. The diagnosis of primary biliary cirrhosis is done based upon patient history and physical examination. Liver function tests, blood test, ultrasound, CT scan, and/or MRI are done to confirm the diagnosis. Ursodiol (Actigal) or ursodeoxycholic acid (UDCA) is the first line of treatment for PBC. Intense itching is one of the most common symptoms of PBC. Over-the-counter antihistamines like diphenhydramine (Benadryl) may be helpful. Other agents such as rifampicin, naltrexone, cholestyramine and sertraline may also be prescribed.
"Primary Biliary Cholangitis - Pipeline Insight, 2021" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Primary Biliary Cholangitis pipeline landscape is provided which includes the disease overview and Primary Biliary Cholangitis treatment guidelines. The assessment part of the report embraces, in depth Primary Biliary Cholangitis 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 Cholangitis 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 Cholangitis R&D. The therapies under development are focused on novel approaches to treat/improve Primary Biliary Cholangitis.
Primary Biliary Cholangitis Emerging Drugs Chapters
This segment of the Primary Biliary Cholangitis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, 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 Cholangitis Emerging Drugs
Elafibranor: Genfit
Elafibranor (GFT505) is an agonist of the peroxisome proliferator-activated receptor-a and peroxisome proliferator-activated receptor-d. Elafibranor was granted Breakthrough Therapy designation by the FDA in April 2019 for the treatment of PBC in adults with inadequate response to UDCA, as well as Orphan Drug Designation by the FDA and the EMA (European Medicines Agency) in July 2019. The drug is in Phase III clinical development for the treatment of Primary Biliary Cholangitis (PBC).
Seladelpar: CymaBay Therapeutics
Seladelpar (MBX-8025) is a potent, selective, orally active peroxisome proliferator-activated receptor d (PPARd) agonist. In February 2019, the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to seladelpar for the treatment of early-stage primary biliary cholangitis (PBC). The drug is in clinical development for the treatment of primary biliary cholangitis (PBC), primary sclerosing cholangitis, and non-alcoholic steatohepatitis.
Primary Biliary Cholangitis: Therapeutic Assessment
This segment of the report provides insights about the different Primary Biliary Cholangitis drugs segregated based on following parameters that define the scope of the report, such as:
Major Players in Primary Biliary Cholangitis
There are approx. 28+ key companies which are developing the therapies for Primary Biliary Cholangitis. The companies which have their Primary Biliary Cholangitis drug candidates in the most advanced stage, i.e. Phase III include, Genfit.
Phases
This report covers around 28+ 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
- Route of Administration
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
- Oral
- Parenteral
- Intravitreal
- Subretinal
- Topical
- Molecule Type
Products have been categorized under various Molecule types such as
- Monoclonal Antibody
- Peptides
- Polymer
- Small molecule
- Gene therapy
- Product Type
The drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
Primary Biliary Cholangitis: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase III, II, I, preclinical and discovery stage. It also analyses Primary Biliary Cholangitis 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 Cholangitis drugs.
Primary Biliary Cholangitis Report Insights
- Primary Biliary Cholangitis Pipeline Analysis
- Therapeutic Assessment
- Unmet Needs
- Impact of Drugs
Primary Biliary Cholangitis Report Assessment
- Pipeline Product Profiles
- Therapeutic Assessment
- Pipeline Assessment
- Inactive drugs assessment
- Unmet Needs
Key Questions Answered
Current Treatment Scenario and Emerging Therapies:
- How many companies are developing Primary Biliary Cholangitis drugs?
- How many Primary Biliary Cholangitis 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 Cholangitis?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Primary Biliary Cholangitis 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 Cholangitis and their status?
- What are the key designations that have been granted to the emerging drugs?
Key Players
- Genfit
- CymaBay Therapeutics
- Mirum Pharmaceuticals
- Gilead Sciences
- Eli Lilly and Company
- Future Medicine
- Ohara Pharmaceutical
- Zydus Cadila
- MYR Pharma
- Selecta Biosciences
Key Products
- Elafibranor
- Seladelpar
- Lopixibat chloride
- Cilofexor
- Baricitinib
- FM 101
- OP 724
- Saroglitazar
- Bulevirtide
- Autoimmune therapy
Research programme: AAV-based gene therapies
Table of Contents
IntroductionExecutive Summary
Primary Biliary Cholangitis: 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 Cholangitis - Analytical Perspective
In-depth Commercial Assessment
- Primary Biliary Cholangitis companies’ collaborations, Licensing, Acquisition -Deal Value Trends
Primary Biliary Cholangitis Collaboration Deals
- Company-Company Collaborations (Licensing/Partnering) Analysis
- Company-University Collaborations (Licensing/Partnering) Analysis
Late Stage Products (Phase III)
- Comparative Analysis
Elafibranor: Genfit
- Product Description
- Research and Development
- Product Development Activities
Mid Stage Products (Phase II)
- Comparative Analysis
Lopixibat chloride: Mirum Pharmaceuticals
- Product Description
- Research and Development
- Product Development Activities
Early Stage Products (Phase I)
- Comparative Analysis
FM 101: Future Medicine
- Product Description
- Research and Development
- Product Development Activities
Preclinical and Discovery Stage Products
- Comparative Analysis
Autoimmune therapy: Selecta Biosciences
- Product Description
- Research and Development
- Product Development Activities
Inactive Products
- Comparative Analysis
Primary Biliary Cholangitis Key Companies
Primary Biliary Cholangitis Key Products
Primary Biliary Cholangitis- Unmet Needs
Primary Biliary Cholangitis- Market Drivers and Barriers
Primary Biliary Cholangitis- Future Perspectives and Conclusion
Primary Biliary Cholangitis Analyst Views
Primary Biliary Cholangitis Key Companies
AppendixList of Tables
Table 1 Total Products for Primary Biliary Cholangitis
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 ProductsList of Figures
Figure 1 Total Products for Primary Biliary Cholangitis
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
Companies Mentioned
A selection of companies mentioned in this report includes:
- Genfit
- CymaBay Therapeutics
- Mirum Pharmaceuticals
- Gilead Sciences
- Eli Lilly and Company
- Future Medicine
- Ohara Pharmaceutical
- Zydus Cadila
- MYR Pharma
- Selecta Biosciences
