Primary Biliary Cholangitis- Pipeline Insight, 2025

DelveInsight’s, “Primary Biliary Cholangitis- Pipeline Insight, 2025” report provides comprehensive insights about 18+ companies and 20+ 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.

Geography Covered

• Global coverage

Primary Biliary Cholangitis: Understanding

Primary Biliary Cholangitis: Overview

Primary Biliary Cholangitis (PBC) is a chronic autoimmune liver disease characterized by progressive destruction of the bile ducts within the liver. This condition primarily affects women, typically between the ages of 30 and 60, though it can occur in men and at other ages. The exact cause of PBC is still unknown, but it's believed to involve a combination of genetic predisposition and environmental factors triggering an autoimmune response against the liver cells.

Signs and symptoms of PBC can vary widely among individuals and may develop gradually over time. Early stages may be asymptomatic or exhibit nonspecific symptoms such as fatigue, itching (pruritus), and dry eyes and mouth. As the disease progresses, more specific symptoms may emerge, including jaundice (yellowing of the skin and eyes), abdominal pain or discomfort, swollen abdomen (ascites), and complications related to liver failure such as portal hypertension.

Several risk factors may increase the likelihood of developing PBC, including being female, having a family history of autoimmune diseases or PBC specifically, and certain environmental triggers such as exposure to toxic substances. Diagnosis of PBC typically involves a combination of medical history, physical examination, blood tests to assess liver function and detect specific antibodies associated with PBC (such as antimitochondrial antibodies), and imaging studies like ultrasound or magnetic resonance cholangiopancreatography (MRCP) to evaluate the bile ducts.

Treatment for PBC aims to slow disease progression, manage symptoms, and prevent complications. Ursodeoxycholic acid (UDCA) is the primary medication used to treat PBC, as it helps improve liver function and may slow the progression of the disease. For individuals who do not respond adequately to UDCA or have advanced disease, other medications such as obeticholic acid may be considered. In some cases, liver transplantation may be necessary for those with end-stage liver disease. Additionally, managing symptoms such as pruritus with medications and lifestyle changes can improve quality of life for individuals with PBC. Regular monitoring and follow-up with healthcare providers are essential to manage the disease effectively and prevent complications.

""Primary Biliary Cholangitis- Pipeline Insight, 2025"" report by DelveInsight 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 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

• Seladelpar: CymaBay Therapeutics, Inc.

Seladelpar is a first-in-class oral, selective peroxisome proliferator-activated receptor (PPAR) delta agonist, or delpar, shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need. Preclinical and clinical data support its ability to regulate genes involved in bile acid synthesis, inflammation, fibrosis and lipid metabolism, storage, and transport. CymaBay Therapeutics, Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational treatment, seladelpar, for the management of primary biliary cholangitis, including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to ursodeoxycholic acid (UDCA). Seladelpar has been granted Breakthrough Therapy Designation by the FDA. Currently, the drug is in Preregistration stage of its 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, Calliditas is conducting a phase 2/3 trial with setanaxib in PBC. In addition, a proof-of-concept study in head and neck cancer is planned to start in Q1 2022. Setanaxib is also being evaluated in two investigator-led clinical trials, a Phase II clinical trial in Type 1 Diabetes and Kidney Disease (DKD) and a 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.

• OP-724: Ohara Pharmaceutical

OP-724 is a synthetic small molecule which is an inhibitor of cyclic AMP response element-binding protein (CREB)-binding protein (CBP)/β-catenin. Ohara Pharmaceutical obtained development rights for OP-724 from PRISM BioLab in 2018. Currently, the drug is in Phase I stage of its development for the treatment of Primary Biliary Cholangitis.

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

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. 18+ 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, CymaBay Therapeutics, Inc.
• Phases

DelveInsight’s report covers around 20+ 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
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

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 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

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

• CymaBay Therapeutics, Inc.
• Calliditas Therapeutics
• Ohara Pharmaceutical
• Pliant Therapeutics
• Parvus Therapeutics
• Shanghai Henlius Biotech
• Gilead Sciences
• Umecrine Cognition
• Mirum Pharmaceuticals, Inc.
• Zydus Therapeutics Inc.
• Intercept Pharmaceuticals
• GlaxoSmithKline

Key Products

• Seladelpar
• Setanaxib
• OP-724
• Bexotegrast
• PVT 201
• HLX 92
• Emtricitabine/tenofovir disoproxil fumarate
• Golexanolone
• Volixibat
• Saroglitazar Magnesium
• Obeticholic Acid (OCA)
• GSK2330672