Primary sclerosing cholangitis (PSC) is a rare, chronic liver disease characterized by inflammation and scarring of the bile ducts. It accounts for around 0.87 cases per 100,000 person-years globally. The current primary sclerosing cholangitis drug pipeline includes bile acid derivatives, immunomodulators, and anti-fibrotic agents. With growing focus on targeted therapies and advanced biologics, the market is expected to witness significant growth in the coming years. According to the primary sclerosing cholangitis pipeline analysis by Expert Market Research, increasing R&D investments and improved diagnostic tools are driving development of novel primary sclerosing cholangitis therapeutic products across clinical phases.
Major companies involved in the primary sclerosing cholangitis pipeline analysis include Cascade Pharmaceuticals, Inc., CuromeBiosciences, and others.
Leading drugs currently in the pipeline include HK-660S, and LB-P8, among others.
The increasing clinical trials, rising focus on FXR agonists, and novel immunomodulatory drug development are driving growth in the primary sclerosing cholangitis pipeline.
The Primary Sclerosing Cholangitis Pipeline Analysis Report by Expert Market Research gives comprehensive insights into primary sclerosing cholangitis therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for primary sclerosing cholangitis. The primary sclerosing cholangitis report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The primary sclerosing cholangitis pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with primary sclerosing cholangitis treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to primary sclerosing cholangitis.
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Primary sclerosing cholangitis (PSC) is a rare, chronic liver disease marked by inflammation and scarring of the bile ducts, leading to bile buildup and liver damage. It often arises alongside inflammatory bowel disease and progresses unpredictably. The exact cause remains unknown, but autoimmune factors and genetic predisposition may contribute to its development and progression.
Primary sclerosing cholangitis treatment currently focuses on managing symptoms, reducing complications, and slowing disease progression, often through bile acid therapy, endoscopic procedures, and, in advanced cases, liver transplantation. In July 2022, Pliant Therapeutics received FDA Fast Track designation for PLN-74809, an oral dual-selective integrin inhibitor, showing promise in Phase 2a trials as a potential disease-modifying therapy for PSC.
Primary sclerosing cholangitis (PSC) remains a rare but serious liver disease with limited treatment options and ongoing research interest. A pooled global incidence rate of 0.87 per 100,000 person-years has been reported, with higher rates in the United States (1.05) and New Zealand (1.11). The prevalence is highest in the United States at 18.60 per 100,000. These findings highlight the need for broader epidemiological studies to support drug development efforts.
This section of the report covers the analysis of primary sclerosing cholangitis drug candidates based on several segmentations, including:
By Phase
By Drug Class
By Route of Administration
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II at 62% covers a major share of the total primary sclerosing cholangitis clinical trials, reflecting strong research focus and promising mid-stage developments. Phase III follows with around 17%, indicating progress toward advanced clinical validation. Phase I accounts for 12.5%, while Early Phase I contributes approximately 8%. The active pipeline across multiple phases supports innovation and may significantly advance treatment options in the primary sclerosing cholangitis market.
The drug molecule categories covered under the primary sclerosing cholangitis pipeline analysis include small molecules, monoclonal antibodies, nucleic acid therapies, gene therapies, peptides, and others. The primary sclerosing cholangitis report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for primary sclerosing cholangitis. Farnesoid X receptor (FXR) agonists are gaining traction in the treatment pipeline for primary sclerosing cholangitis. For instance, Dr. Falk Pharma’s norucholic acid, a modified bile acid and FXR agonist, has shown positive outcomes in a Phase III trial. The therapy demonstrated significant improvement in liver enzyme levels and halted disease progression, highlighting its potential as a promising therapeutic candidate.
The EMR report for the primary sclerosing cholangitis pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed primary sclerosing cholangitis therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in primary sclerosing cholangitis clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for primary sclerosing cholangitis. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of primary sclerosing cholangitis drug candidates.
HK-660S is a synthetic beta-lapachone compound currently being evaluated by CuromeBiosciences in a Phase 2b clinical study for the treatment of primary sclerosing cholangitis (PSC). The study is assessing the efficacy and safety of HK-660S, which targets the NQO1 enzyme to elevate NAD⁺ levels and activate sirtuins involved in energy metabolism. The objective is to determine if HK-660S can reduce serum ALP by at least 20% over 12 weeks.
LB-P8, developed by LISCure Biosciences, is currently being evaluated in a Phase 2 randomized, double-blind, placebo-controlled trial for patients with primary sclerosing cholangitis (PSC). The objective of this phase is to assess the safety, tolerability, and efficacy of LB-P8, a live probiotic containing Leuconostoc citreum, commonly found in kimchi. LB-P8 is aiming to improve gut-liver axis function to reduce bile buildup, liver inflammation, and fibrosis.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Primary Sclerosing Cholangitis Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for primary sclerosing cholangitis. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into primary sclerosing cholangitis collaborations, regulatory environments, and potential growth opportunities.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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