Primary Biliary Cholangitis (PBC)- Pipeline Insight, 2025

This “Primary Biliary Cholangitis (PBC)- Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Primary Biliary Cholangitis (PBC) 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): Understanding

Primary Biliary Cholangitis (PBC): Overview

Primary Biliary Cholangitis (PBC) is a chronic, progressive autoimmune disease that primarily affects the bile ducts in the liver. It leads to inflammation and gradual destruction of the small bile ducts, causing bile to accumulate in the liver (cholestasis). Over time, this can result in liver damage, fibrosis, and eventually cirrhosis. Although the exact cause of PBC remains unclear, it predominantly affects middle-aged women and is considered an autoimmune disorder. Genetic and environmental factors, such as infections or toxic exposures, may contribute to its onset.

Early stages of PBC may be asymptomatic, but as the disease progresses, common symptoms include persistent fatigue, pruritus (itching), and dry eyes or mouth. Advanced stages can lead to jaundice (yellowing of the skin and eyes), dark urine, pale stools, and swelling in the abdomen or legs due to fluid retention. Complications include vitamin deficiencies, osteoporosis, and an increased risk of liver failure or hepatocellular carcinoma.

The exact cause of PBC is unknown, but it is thought to result from an autoimmune reaction where the body's immune system mistakenly attacks the bile ducts. A genetic predisposition may play a role, as PBC is more common in individuals with a family history of autoimmune diseases. Environmental triggers, such as infections or toxins, might also contribute to initiating the immune response.

PBC is typically diagnosed through a combination of blood tests, imaging studies, and sometimes liver biopsy. Elevated levels of alkaline phosphatase (ALP) and other liver enzymes suggest bile duct dysfunction. The presence of antimitochondrial antibodies (AMA) in the blood is a key diagnostic marker, present in over 90% of cases. Imaging tests like ultrasound or MRI rule out other conditions affecting the bile ducts, and a liver biopsy may confirm the diagnosis and assess disease severity.

There is no cure for PBC, but treatments aim to slow disease progression, alleviate symptoms, and manage complications. Ursodeoxycholic acid (UDCA) is the first-line medication that improves bile flow and liver function. Obeticholic acid (OCA) may be prescribed for patients unresponsive to UDCA. Symptomatic treatments include antihistamines for itching and supplements for vitamin deficiencies. Advanced cases may require liver transplantation, which is curative. Lifestyle modifications, such as avoiding alcohol and maintaining a balanced diet, are also recommended to support liver health.

'Primary Biliary Cholangitis (PBC)- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Primary Biliary Cholangitis (PBC) pipeline landscape is provided which includes the disease overview and Primary Biliary Cholangitis (PBC) treatment guidelines. The assessment part of the report embraces, in depth Primary Biliary Cholangitis (PBC) 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 (PBC) 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 (PBC) R&D. The therapies under development are focused on novel approaches to treat/improve Primary Biliary Cholangitis (PBC).

Primary Biliary Cholangitis (PBC) Emerging Drugs Chapters

This segment of the Primary Biliary Cholangitis (PBC) report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III 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 (PBC) Emerging Drugs

Saroglitazar Magnesium: Zydus Therapeutics

Saroglitazar (LIPAGLYN) contains two main classes of PPAR agonists, which include PPARα (alpha) and PPARγ (gamma). The drug has lipid and glucose-lowering effects in a single molecule; it lowers high blood triglycerides and blood sugar and improves insulin resistance. The drug is available in tablet form of 4 mg dose for oral administration. Saroglitazar is indicated for treating diabetic dyslipidemia and hypertriglyceridemia with type 2 diabetes mellitus not controlled by statin therapy. In clinical studies, saroglitazar has demonstrated a reduction of triglycerides (TG), LDL cholesterol, VLDL cholesterol, and non-HDL cholesterol and an increase in HDL cholesterol, a characteristic hallmark of atherogenic diabetic dyslipidemia (ADD). The US FDA has granted ODD and FTD to saroglitazar Mg for PBC. It is currently being investigated in Phase III stage of clinical 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, a phase II/III trial with Setanaxib in PBC was initiated. Setanaxib is also being evaluated in an investigator-initiated Phase II clinical trial in Type 1 Diabetes and Kidney Disease (DKD) as well as being studied in an investigator led Phase II clinical trial in idiopathic pulmonary fibrosis (IPF), a chronic lung disease that results in fibrosis of the lungs.

HPG-1860: Hepagene

HPG-1860 is under development for the treatment of non-alcoholic steatohepatitis (NASH), Primary Biliary Cholangitis. It is administered by oral route. The drug candidate is an avermectin derivative and acts by targeting farnesoid X activated receptor. The drug is currently in phase I stage of development for the treatment of PBC. The drug is currently in Phase I stage of its clinical development for the study of Primary Biliary Cholangitis (PBC).

Primary Biliary Cholangitis (PBC): Therapeutic Assessment

This segment of the report provides insights about the different Primary Biliary Cholangitis (PBC) drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Primary Biliary Cholangitis (PBC)

There are approx. 20+ key companies which are developing the therapies for Primary Biliary Cholangitis (PBC). The companies which have their Primary Biliary Cholangitis (PBC) drug candidates in the most advanced stage, i.e. Phase III include, Zydus Therapeutics.

Phases

The 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 Cholangitis (PBC) pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intravenous
• Subcutaneous
• Oral
• Intramuscular

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Primary Biliary Cholangitis (PBC): 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 (PBC) 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 (PBC) drugs.

Primary Biliary Cholangitis (PBC) Report Insights

• Primary Biliary Cholangitis (PBC) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Primary Biliary Cholangitis (PBC) 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 (PBC) drugs?
• How many Primary Biliary Cholangitis (PBC) 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 (PBC)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Primary Biliary Cholangitis (PBC) 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 (PBC) and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Zydus Therapeutics
• Calliditas Therapeutics
• Hepagene
• Calliditas Therapeutics
• Dr Falk Pharma
• Mirum Pharmaceuticals
• GlaxoSmithKline

Key Products

• Saroglitazar Magnesium
• Setanaxib
• HPG-1860
• Setanaxib
• Norucholic acid
• RhuDex
• Volixibat
• linerixibat

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