Primary Sclerosing Cholangitis Pipeline 2025: FDA Updates, Therapy Innovations, and Clinical Trial Landscape Analysis by DelveInsight

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Primary Sclerosing Cholangitis pipeline constitutes 14+ key companies continuously working towards developing 14+ Primary Sclerosing Cholangitis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Primary Sclerosing Cholangitis Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Primary Sclerosing Cholangitis Market.

The Primary Sclerosing Cholangitis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, FDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Primary Sclerosing Cholangitis Pipeline Report: https://www.delveinsight.com/sample-request/primary-sclerosing-cholangitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Primary Sclerosing Cholangitis treatment therapies with a considerable amount of success over the years.
• Primary Sclerosing Cholangitis companies working in the treatment market are HighTide Biopharma, Gilead Sciences, Immunic, Engitix, GRI Bio, Qing Bile Therapeutics, Sirnaomics, Cascade Pharmaceuticals, Chemomab Therapeutics, Mirum Pharmaceuticals, Pliant Therapeutics, Inc., HighTide Biopharma, Dr. Falk Pharma, Mirum Pharmaceuticals, CymaBay Therapeutics, Ipsen, Genfit, Albireo, and others, are developing therapies for the Primary Sclerosing Cholangitis treatment
• Emerging Primary Sclerosing Cholangitis therapies in the different phases of clinical trials are- HTD 1801, GS-9674, IMU-838, Research programme-antifibrotic therapeutics, GRI-0124, QBT-002, STP707, CS0159, CM 101, Volixibat, PLN-74809 (bexotegrast), HTD1801, Norursodeoxycholic acid, Volixibat, Seladelpar, Elafibranor, A3907, and others are expected to have a significant impact on the Primary Sclerosing Cholangitis market in the coming years.
• In September 2025, Enrollment has been finalized for the Phase 2b VISTAS trial evaluating the oral investigational therapy volixibat in patients experiencing itching related to primary sclerosing cholangitis (PSC). The study, which enrolled 182 participants, is anticipated to release top-line results between April and June of next year.
• In August 2025, Chemomab Therapeutics reached alignment with U.S. regulators on key elements of the late-stage development of nebokitug, its investigational therapy for primary sclerosing cholangitis (PSC), while continuing to seek a strategic partner for the upcoming Phase 3 trial. In prior discussions with the FDA, it was agreed that a single Phase 3 study evaluating PSC progression-related outcomes would be adequate to support a future approval submission, provided the results demonstrate positive efficacy.
• In June 2025, Chemomab Therapeutics Ltd. (Nasdaq: CMMB), a clinical-stage biotech developing innovative treatments for fibro-inflammatory diseases with high unmet need, announced that it has received FDA confirmation on two key development milestones as it progresses the nebokitug Phase 3 program. During the FDA End-of-Phase 2 (EOP2) review, Chemomab and the FDA discussed multiple Chemistry, Manufacturing, and Controls (CMC) topics essential for ensuring drug quality and supply consistency for late-stage development and future commercialization. The FDA expressed agreement with the CMC strategy proposed by Chemomab and its contract manufacturing partner.
• In May 2025, Dr. Falk Pharma's norucholic acid (NCA) has shown promising results in a Phase III study for primary sclerosing cholangitis (PSC). In the pivotal NUC-5 trial (NCT03872921), NCA achieved statistically significant improvements over placebo in meeting the combined primary goals of partially normalizing alkaline phosphatase levels-a liver enzyme associated with PSC-and preventing disease progression as seen on histology. Additionally, NCA demonstrated notable benefits across several secondary endpoints, with safety and tolerability profiles comparable between the NCA and placebo groups.
• In May 2025, Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD), a clinical-stage biopharmaceutical company focused on cardiometabolic and gastrointestinal oncology conditions, has announced promising preclinical results for Aramchol in models of primary sclerosing cholangitis (PSC). Fibroinflammatory cholangiopathies like PSC and primary biliary cholangitis (PBC) involve cholestatic damage, inflammation, and fibrosis-driven bile duct obstruction, leading to disease complications. Aramchol, a stearoyl-CoA desaturase 1 (SCD-1) inhibitor, demonstrated both preventive and therapeutic effects on biliary fibrosis in mouse models of PSC. The drug dose-dependently reduced the expression of fibrotic markers such as plasminogen activator inhibitor-1 and key hepatic stellate cell activation genes (VEGFA and PDGFB) in TGFβ-stimulated human cholangiocyte (H69) and mouse biliary epithelial cells (MLEs). Additionally, Aramchol significantly inhibited TGFβ-driven hepatic fibrosis pathways while enhancing peroxisome proliferator-activated receptor (PPAR) signaling.
• In March 2025, Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), a clinical-stage biotech company focused on developing novel therapies for fibro-inflammatory diseases with significant unmet needs, recently shared encouraging findings from the Open Label Extension (OLE) phase of its Phase 2 SPRING trial evaluating nebokitug in patients with primary sclerosing cholangitis (PSC). Over 90% of eligible SPRING trial participants opted to enroll in the OLE. During this extension, patients previously treated with nebokitug in the 15-week double-blind phase received an additional 33 weeks of therapy, totaling up to 48 weeks, while those initially on placebo crossed over to receive 33 weeks of nebokitug treatment.
• In July 2024, Chemomab Therapeutics Ltd. (Nasdaq: CMMB), a clinical-stage biotechnology company focused on developing innovative therapies for fibro-inflammatory diseases with significant unmet needs, has announced positive topline results from its Phase 2 SPRING trial evaluating its first-in-class monoclonal antibody, CM-101, in patients with primary sclerosing cholangitis (PSC). CM-101 successfully met its primary endpoint of safety and tolerability and showed anti-fibrotic, anti-inflammatory, and anti-cholestatic effects across various disease-related secondary efficacy endpoints, including a statistically significant improvement in liver stiffness, a critical marker for PSC. CM-101 is the first investigational drug developed for PSC that demonstrates broad, clinically relevant effects on all three disease components, supporting its multifactorial mechanism of action and potential for disease modification.

Primary Sclerosing Cholangitis Overview
Primary Sclerosing Cholangitis (PSC) is a rare, chronic liver disease characterized by inflammation and scarring of the bile ducts, which can lead to bile flow obstruction, liver damage, and eventually cirrhosis. The exact cause is unknown, but it is often associated with autoimmune conditions, particularly inflammatory bowel disease (IBD). PSC progresses slowly and may cause fatigue, itching, jaundice, and abdominal pain, but many patients remain asymptomatic in early stages. There is currently no cure, and treatment focuses on managing symptoms, preventing complications, and monitoring for liver failure or bile duct cancer.

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Emerging Primary Sclerosing Cholangitis Drugs Under Different Phases of Clinical Development Include:
• HTD 1801: HighTide Biopharma
• GS-9674: Gilead Sciences
• IMU-838: Immunic
• Research programme: antifibrotic therapeutics Engitix
• GRI-0124: GRI Bio
• QBT-002: Qing Bile Therapeutics
• STP707: Sirnaomics
• CS0159: Cascade Pharmaceuticals
• CM 101: Chemomab Therapeutics
• Volixibat: Mirum Pharmaceuticals
• PLN-74809 (bexotegrast): Pliant Therapeutics, Inc.
• HTD1801: HighTide Biopharma
• Norursodeoxycholic acid: Dr. Falk Pharma
• Volixibat: Mirum Pharmaceuticals
• Seladelpar: CymaBay Therapeutics
• Elafibranor: Ipsen/Genfit
• A3907: Albireo/IPSEN

Primary Sclerosing Cholangitis Route of Administration
Primary Sclerosing 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

Primary Sclerosing Cholangitis Molecule Type
Primary Sclerosing Cholangitis Products have been categorized under various Molecule types, such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy
• Product Type

Primary Sclerosing Cholangitis Pipeline Therapeutics Assessment
• Primary Sclerosing Cholangitis Assessment by Product Type
• Primary Sclerosing Cholangitis By Stage and Product Type
• Primary Sclerosing Cholangitis Assessment by Route of Administration
• Primary Sclerosing Cholangitis By Stage and Route of Administration
• Primary Sclerosing Cholangitis Assessment by Molecule Type
• Primary Sclerosing Cholangitis by Stage and Molecule Type

DelveInsight's Primary Sclerosing Cholangitis Report covers around 14+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Primary Sclerosing Cholangitis product details are provided in the report. Download the Primary Sclerosing Cholangitis pipeline report to learn more about the emerging Primary Sclerosing Cholangitis therapies
https://www.delveinsight.com/sample-request/primary-sclerosing-cholangitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key companies in the Primary Sclerosing Cholangitis Therapeutics Market include:
Key companies developing therapies for Primary Sclerosing Cholangitis are - HighTide Biopharma, Dr. Falk Pharma, Mirum Pharmaceuticals, Pliant Therapeutics, Inc., Chemomab Therapeutics, CymaBay Therapeutics, Genfit, Albireo, IPSEN, and others.

Primary Sclerosing Cholangitis Pipeline Analysis:
The Primary Sclerosing Cholangitis pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Primary Sclerosing Cholangitis with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Primary Sclerosing Cholangitis Treatment.
• Primary Sclerosing Cholangitis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Primary Sclerosing Cholangitis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Primary Sclerosing Cholangitis market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Primary Sclerosing Cholangitis drugs and therapies
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Primary Sclerosing Cholangitis Pipeline Market Drivers
• Increasing prevalence of diseases associated with PSC such as liver cancer and inflammatory bowel disease, A rising number of research studies on PSC are some of the important factors that are fueling the Primary Sclerosing Cholangitis Market.

Primary Sclerosing Cholangitis Pipeline Market Barriers
• However, withdrawal of molecules from late clinical stages, lack of skilled professionals or trained expertise and other factors are creating obstacles in the Primary Sclerosing Cholangitis Market growth.

Scope of Primary Sclerosing Cholangitis Pipeline Drug Insight
• Coverage: Global
• Key Primary Sclerosing Cholangitis Companies: HighTide Biopharma, Gilead Sciences, Immunic, Engitix, GRI Bio, Qing Bile Therapeutics, Sirnaomics, Cascade Pharmaceuticals, Chemomab Therapeutics, Mirum Pharmaceuticals, Pliant Therapeutics, Inc., HighTide Biopharma, Dr. Falk Pharma, Mirum Pharmaceuticals, CymaBay Therapeutics, Ipsen, Genfit, Albireo, and others
• Key Primary Sclerosing Cholangitis Therapies: HTD 1801, GS-9674, IMU-838, Research programme-antifibrotic therapeutics, GRI-0124, QBT-002, STP707, CS0159, CM 101, Volixibat, PLN-74809 (bexotegrast), HTD1801, Norursodeoxycholic acid, Volixibat, Seladelpar, Elafibranor, A3907, and others
• Primary Sclerosing Cholangitis Therapeutic Assessment: Primary Sclerosing Cholangitis current marketed and Primary Sclerosing Cholangitis emerging therapies
• Primary Sclerosing Cholangitis Market Dynamics: Primary Sclerosing Cholangitis market drivers and Primary Sclerosing Cholangitis market barriers

Contact Us:
Gaurav Bora
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About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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