DelveInsight’s comprehensive “Primary Sclerosing Cholangitis Pipeline Insights 2025” report delivers extensive analysis of more than 14 pharmaceutical companies and over 14 investigational drugs currently in the Primary Sclerosing Cholangitis development pipeline. The report encompasses detailed profiles of Primary Sclerosing Cholangitis treatment candidates spanning both clinical and preclinical development phases. Additionally, it includes thorough evaluation of Primary Sclerosing Cholangitis therapeutics organized by product classification, developmental stage, administration method, and molecular structure. The report also identifies dormant pipeline candidates in this therapeutic space.
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Major Highlights from the Primary Sclerosing Cholangitis Pipeline Analysis
- On October 24, 2025, LISCure Biosciences launched an investigation engineered to evaluate the safety profile and therapeutic effectiveness of LB-P8 in individuals with primary sclerosing cholangitis. Part 1 will assess safety and tolerability of 2 pre-selected dose levels of LB-P8 (low-dose [1 times 10^10 CFU/capsule] and high dose [1 times 10^11 CFU/capsule]) in adult individuals with PSC. Part 1 plans to recruit a maximum number of 12 individuals based on a “3+3” study design.
- On October 23, 2025, HighTide Biopharma Pty Ltd initiated an investigation that was a dose-ranging, 18-week trial comparing two doses of HTD1801 (500 mg BID and 1000 mg BID) to placebo in adult subjects with PSC.
- DelveInsight’s Primary Sclerosing Cholangitis pipeline analysis reveals a dynamic landscape featuring over 14 active pharmaceutical developers advancing more than 14 investigational treatments for Primary Sclerosing Cholangitis.
- Key Primary Sclerosing Cholangitis developers include Gilead Sciences, Immunic, Dr Falk Pharma, Pliant Therapeutics, CymaBay Therapeutics, SCOHIA PHARMA, Albireo Pharma, Sirnaomics, Morphic Therapeutic, among others.
- Notable Primary Sclerosing Cholangitis Pipeline treatment candidates comprise Ritivixibat, HK-660S, Cenicriviroc 150 mg, Elafibranor 80 mg, BTT1023, PLN-74809, Volixibat, among others.
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Primary Sclerosing Cholangitis Investigational Drug Profiles
GS-9674: Gilead Sciences
GS-9674 (Cilofexor) represents an orally active, small molecule-based nonsteroidal FXR agonist. The drug undergoes Phase III clinical evaluation for Primary sclerosing cholangitis treatment.
IMU-838: Immunic
IMU-838 represents a small molecule investigational drug (vidofludimus calcium) under advancement as an oral tablet formulation for PSC treatment. The drug undergoes clinical evaluation for Relapsing-Remitting Multiple Sclerosis, Progressive Multiple Sclerosis, Ulcerative Colitis, Crohn’s Disease, and Primary Sclerosing Cholangitis treatment. The drug undergoes Phase II clinical evaluation for Primary sclerosing cholangitis treatment.
Key Insights from the Primary Sclerosing Cholangitis Pipeline Report
The report delivers comprehensive information regarding:
- Pharmaceutical companies developing treatments for Primary Sclerosing Cholangitis management with aggregate therapeutic candidates created by each organization for the same.
- Multiple investigational candidates organized across early-phase, mid-phase, and late-phase development for Primary Sclerosing Cholangitis therapy.
- Primary Sclerosing Cholangitis pharmaceutical companies pursuing targeted therapeutic development, including both active and inactive (suspended or terminated) programs.
- Primary Sclerosing Cholangitis investigational drugs categorized by development phase, administration route, target receptor, monotherapy versus combination therapy, mechanism of action, and molecular classification.
- In-depth examination of partnerships (pharmaceutical-pharmaceutical and pharmaceutical-academic collaborations), licensing arrangements, and funding details for future Primary Sclerosing Cholangitis market progression.
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Primary Sclerosing Cholangitis Pharmaceutical Companies
Gilead Sciences, Immunic, Dr Falk Pharma, Pliant Therapeutics, CymaBay Therapeutics, SCOHIA PHARMA, Albireo Pharma, Sirnaomics, Morphic Therapeutic, among others.
Primary Sclerosing Cholangitis Pipeline Report: Therapeutic Classification by Administration Route
Investigational products have been organized under multiple administration routes including:
- Oral
- Parenteral
- Intravitreal
- Subretinal
- Topical
- Molecule Type
Primary Sclerosing Cholangitis Products: Molecular Classification
Candidates have been grouped under various molecular categories including:
- Monoclonal Antibody
- Peptides
- Polymer
- Small molecule
- Gene therapy
- Product Type
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Report Scope
- Coverage: Global
- Primary Sclerosing Cholangitis Pharmaceutical Companies: Gilead Sciences, Immunic, Dr Falk Pharma, Pliant Therapeutics, CymaBay Therapeutics, SCOHIA PHARMA, Albireo Pharma, Sirnaomics, Morphic Therapeutic, among others.
- Primary Sclerosing Cholangitis Pipeline Investigational Therapies: Ritivixibat, HK-660S, Cenicriviroc 150 mg, Elafibranor 80 mg, BTT1023, PLN-74809, Volixibat, among others.
- Primary Sclerosing Cholangitis Therapeutic Classification by Product Type: Mono, Combination, Mono/Combination
- Primary Sclerosing Cholangitis Therapeutic Classification by Clinical Phases: Discovery, Pre-clinical, Phase I, Phase II, Phase III
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Report Contents
* Introduction
* Executive Summary
* Primary Sclerosing Cholangitis: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Primary Sclerosing Cholangitis – DelveInsight’s Analytical Perspective
* Late Stage Products (Phase III)
* GS-9674: Gilead Sciences
* Drug profiles in the detailed report…..
* Mid Stage Products (Phase II)
* IMU-838: Immunic
* Drug profiles in the detailed report…..
* Early Stage Products (Phase I)
* SCO-240: SCOHIA PHARMA
* Drug profiles in the detailed report…..
* Preclinical and Discovery Stage Products
* MORF 627: Morphic Therapeutic
* Drug profiles in the detailed report…..
* Inactive Products
* Primary Sclerosing Cholangitis Key Companies
* Primary Sclerosing Cholangitis Key Products
* Primary Sclerosing Cholangitis- Unmet Needs
* Primary Sclerosing Cholangitis- Market Drivers and Barriers
* Primary Sclerosing Cholangitis- Future Perspectives and Conclusion
* Primary Sclerosing Cholangitis Analyst Views
* Appendix
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