(Albany, USA) DelveInsight’s “Liver Cirrhosis Pipeline Insight 2025” report provides a detailed assessment of the global liver cirrhosis therapeutic landscape, focusing on drugs currently undergoing clinical development. The report identifies leading pharmaceutical innovators and highlights significant growth prospects across the liver cirrhosis pipeline.
The liver cirrhosis treatment market is projected to witness substantial growth, driven by the increasing global prevalence of liver diseases—particularly NAFLD—associated with rising obesity levels, alcohol consumption, and metabolic syndrome. Progress in antiviral therapies and regenerative medicine is enhancing clinical outcomes, while the aging population continues to fuel demand, collectively signaling a strong and rapidly evolving market outlook.
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Key Highlights from the Liver Cirrhosis Pipeline Report
- DelveInsight’s liver cirrhosis pipeline analysis reveals a robust development ecosystem, with over 30 companies actively advancing more than 30 therapeutic candidates.
- Key stakeholders in the liver cirrhosis space include Sagimet Biosciences, Gwo Xi Stem Cell Applied Technology, AstraZeneca, Galectin Therapeutics, Vedanta Biosciences, Resolution Therapeutics, Mirum Pharmaceuticals, TenNor Therapeutics, Prism Pharma, Ipsen, Versantis AG, Lipocine, and others.
- Prominent investigational therapies—such as Volixibat, VS-01, TVB-2640, TNP-2092, PRI-724, VE303, LPCN 1148, GXHPC1, Belapectin, RTX001, Elafibranor, Zibotentan, and several more—are advancing across multiple stages of clinical development.
- In February 2025, Sagimet disclosed lipidomic data from its Phase IIb FASCINATE-2 trial, examining triglyceride and LDL cholesterol profiles in patients with advanced fibrosis. The findings are scheduled for presentation at the Keystone Symposium on MASH Pathogenesis and Therapeutics. Additionally, the US FDA granted denifanstat both Breakthrough Therapy and Fast Track designations for non-cirrhotic MASH with moderate-to-advanced fibrosis.
- Madrigal Pharmaceuticals intends to launch REZDIFFRA in Europe—beginning with Germany—in the latter half of 2025, subject to EMA approval. If authorized, it would become the first approved therapy for MASH-related liver fibrosis in Europe. Updated two-year MAESTRO-NAFLD-1 data released in February 2025 indicate potential clinical benefits in patients with compensated MASH cirrhosis, broadening its clinical applicability.
- In January 2025, Akero Therapeutics announced the completion of patient enrollment in its Phase III SYNCHRONY Real-World study for MASH/MASLD (F1–F4), with results expected in the first half of 2026.
- During the same month, the company reaffirmed strong momentum across its Phase III MASH programs and plans to release topline results from its first Phase III study by the end of 2025. Two additional Phase III trials—ENLIGHTEN-Fibrosis for non-cirrhotic MASH (F2–F3) and ENLIGHTEN-Cirrhosis for compensated MASH cirrhosis (F4)—are actively enrolling patients worldwide.
- In December 2024, Galectin Therapeutics announced results from the NAVIGATE global clinical trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension.
- In October 2024, PharmaIN Corporation revealed plans to present interim findings from its Phase I clinical study of PHIN-214, a lead candidate designed to prevent and treat decompensated cirrhosis.
- In June 2024, Resolution Therapeutics, in partnership with the University of Edinburgh, showcased key RTX001 data at the EASL Congress 2024 in Milan, highlighting the promise of macrophage cell therapy for advanced liver cirrhosis management.
- Also in June 2024, Lipocine presented Phase II data for LPCN 1148 in cirrhosis during a late-breaking oral session at the EASL Congress in Milan.
- In April 2024, LyGenesis announced dosing of the first patient in its Phase IIa trial evaluating a novel allogeneic regenerative cell therapy administered into lymph nodes for end-stage liver disease (ESLD).
- In March 2024, Lipocine reported encouraging topline results from its Phase II study of LPCN 1148, an oral therapy under development for liver cirrhosis treatment.
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Liver Cirrhosis Overview
Liver cirrhosis is an advanced, chronic liver disorder marked by extensive fibrosis resulting from prolonged liver injury. Common etiologies include chronic alcohol consumption, viral hepatitis (HBV and HCV), nonalcoholic fatty liver disease (NAFLD/MASH), and metabolic abnormalities. As scar tissue progressively replaces healthy liver tissue, hepatic blood flow becomes compromised, leading to impaired detoxification, metabolic regulation, and nutrient processing. Clinical manifestations range from fatigue and jaundice to severe complications such as ascites, variceal hemorrhage, and hepatic encephalopathy. Without early intervention, cirrhosis may advance to liver failure, often necessitating transplantation.
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Liver Cirrhosis Competitive Landscape Analysis
The liver cirrhosis pipeline report presents a comprehensive evaluation of emerging therapies, categorized by development stage, product classification, molecular type, route of administration, and mechanism of action.
- Elafibranor: Ipsen
- Volixibat: Mirum Pharmaceuticals
- GXHPC1: Gwo Xi Stem Cell Applied Technology
- RTX-001: Resolution Therapeutics
- PHIN-214: PharmaIN
Learn more about the emerging liver cirrhosis therapies @ Liver Cirrhosis Clinical Trials and FDA Approvals
Scope of the Liver Cirrhosis Pipeline Report
- Geographic Coverage: Global
- Therapeutic Classification by Product Type: Monotherapy, Combination Therapy, Mono/Combination
- Assessment by Development Stage: Discovery, Preclinical, Phase I, Phase II, Phase III
- Route of Administration Analysis: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal
- Molecule Type Assessment: Oligonucleotides, Peptides, Small Molecules
- Mechanism of Action Coverage: Sodium-bile acid cotransporter inhibition, Regulatory T-cell stimulation, Ammonia scavenging, DNA gyrase inhibition, DNA topoisomerase inhibition, DNA-directed RNA polymerase inhibition, Beta-catenin inhibition, CREB-binding protein inhibition, Wnt signaling pathway modulation, Bacterial replacement strategies, Microbiome modulation
- Key Companies: Sagimet Biosciences, Gwo Xi Stem Cell Applied Technology, AstraZeneca, Galectin Therapeutics, Vedanta Biosciences, Resolution Therapeutics, Mirum Pharmaceuticals, TenNor Therapeutics, Prism Pharma, Ipsen, Versantis AG, Lipocine, among others
- Leading Pipeline Therapies: Volixibat, VS-01, TVB-2640, TNP-2092, PRI-724, VE303, Obeticholic Acid (OCA), BI 685509, OP-724, OCE-205, GKT137831, GB1211, Cellgram-LC, and others
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Table of Contents
- Introduction to the Liver Cirrhosis Pipeline Report
- Executive Summary
- Liver Cirrhosis Pipeline Overview
- In-depth Analytical and Commercial Assessment
- Clinical Trial Therapeutics Analysis
- Late-Stage Pipeline Products (Pre-registration)
- Late-Stage Pipeline Products (Phase III)
- Mid-Stage Pipeline Products (Phase II)
- Early-Stage Pipeline Products (Phase I)
- Therapeutic Assessment of Liver Cirrhosis Pipeline
- Inactive Liver Cirrhosis Pipeline Assets
- Licensing and Partnering (Company–University Collaboration) Analysis
- Key Companies Profiled
- Key Pipeline Products
- Unmet Clinical Needs
- Market Drivers and Challenges
- Future Outlook and Conclusions
- Analyst Perspectives
- Appendix
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