Primary biliary cirrhosis- Pipeline Insight, 2025

DelveInsight’s, “Primary biliary cirrhosis- Pipeline Insight, 2025” report provides comprehensive insights about 25+ companies and 25+ 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 and slowly progressive cholestatic liver disease of autoimmune etiology characterized by injury of the intrahepatic bile ducts that may eventually lead to liver failure. Affected individuals are usually in their fifth to seventh decades of life at time of diagnosis, and 90% are women. Annual incidence is estimated between 0.7 and 49 cases per million-population and prevalence between 6.7 and 940 cases per million-population (depending on age and sex). PBC does not always cause symptoms, but some people may experience: bone and joint aches, fatigue (extreme tiredness), itchy skin, dry eyes and mouth, pain or discomfort in the upper right side of their tummy. The majority of patients are asymptomatic at diagnosis, however, some patients present with symptoms of fatigue and/or pruritus. Patients may even present with ascites, hepatic encephalopathy and/or esophageal variceal hemorrhage. Genetic susceptibility as a predisposing factor for PBC has been suggested. Environmental factors may have potential causative role (infection, chemicals, smoking). Diagnosis is based on a combination of clinical features, abnormal liver biochemical pattern in a cholestatic picture persisting for more than six months and presence of detectable antimitochondrial antibodies (AMA) in serum. All AMA negative patients with cholestatic liver disease should be carefully evaluated with cholangiography and liver biopsy. Ursodeoxycholic acid (UDCA) is the only currently known medication that can slow the disease progression.

""Primary biliary cirrhosis- 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 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

• Elafibranor: Genfit

Elafibranor is an investigational compound. GENFIT is currently evaluating its proprietary drug candidate, elafibranor, a dual agonist of PPARα and PPARδ in PBC. Targeting PPAR receptors may result in a reduction of bile acid synthesis, improved detoxification of bile in the bile duct and anti-inflammatory activity. The use of drugs targeting PPAR receptors has been shown to reduce blood levels of Alkaline Phosphatase (ALP), and improve biochemical measures of cholestasis and pruritus (itching) in patients with PBC.

• Seladelpar: CymaBay Therapeutics

Seladelpar (MBX-8025) is a potent, selective, orally active peroxisome proliferator-activated receptor δ (PPARδ) agonist in development for the treatment of patients with the autoimmune liver disease, primary biliary cholangitis (PBC). It has received Breakthrough Therapy Designation (FDA) and PRIME status (EMEA); Orphan Drug Designation in U.S. and Europe. Backed by an extensive body of clinical evidence and global patient experience through its Phase 2 and Phase 3 (ENHANCE) studies of seladelpar in Primary Biliary Cholangitis (PBC), CymaBay initiated an international pivotal Phase 3 study (RESPONSE) in early 2021.

• Setanaxib: Calliditas Therapeutics

Calliditas’ pipeline contains development programs based on a first in class, novel NOX inhibitor platform that includes lead compound setanaxib, the first NOX inhibitor to reach the clinical trial stage. NOX enzyme inhibitors are a set of promising novel experimental drugs in a new therapeutic class, recognised by the WHO since 2019 when it approved “naxib” as a new stem. Calliditas launched trials with setanaxib in Primary Biliary Cholangitis (PBC) and in Squamous Cell Carcinoma of the Head & Neck (SCCHN).

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. 25+ key companies which are developing the therapies for Primary biliary cirrhosis. The companies which have their Primary biliary cirrhosis drug candidates in the most advanced stage, i.e. phase III include, Genfit.

• Phases

DelveInsight’s 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) 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

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

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule
• 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

• Genfit
• CymaBay Therapeutics
• Calliditas Therapeutics
• Zydus-Cadila
• Chia Tai Tianqing Pharmaceutical Group
• Cour Pharmaceutical Development
• Ascletis
• Novartis
• Mirum Pharmaceuticals
• Intercept Pharmaceuticals
• HighTide Biopharma
• PRISM Pharma Co
• GlaxoSmithKline

Key Products

• Elafibranor
• Seladelpar
• Setanaxib
• Bilypsa
• TQA3526
• CNP-104
• ASC42
• LJN-452
• Volixibat
• Bezafibrate
• HTD1801
• OP-724
• Linerixibat