(Albany, USA) DelveInsight’s “Liver Cirrhosis Pipeline Insight 2025” report delivers an in-depth overview of the global landscape of liver cirrhosis therapies currently in clinical development. It highlights the key pharmaceutical companies driving innovation in this space and the promising growth opportunities within the liver cirrhosis pipeline.
The liver cirrhosis treatment market is expected to expand considerably, propelled by the growing worldwide burden of liver disorders especially NAFLD, linked to rising obesity rates, alcohol use, and metabolic syndrome. Advances in antiviral treatments and regenerative medicine are improving patient outcomes, while an aging population continues to elevate demand. Together, these trends underscore a robust and accelerating market outlook.
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Key Takeaways from the Liver Cirrhosis Pipeline Report
- DelveInsight’s liver cirrhosis pipeline report highlights a strong landscape, featuring more than 30 companies developing over 30 drug candidates for liver cirrhosis.
- Major players in the liver cirrhosis domain - including 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.
- Notable investigational liver cirrhosis therapies such as Volixibat, VS-01, TVB-2640, TNP-2092, PRI-724, VE303, LPCN 1148, GXHPC1, Belapectin, RTX001, Elafibranor, Zibotentan, and several others are progressing through various stages of clinical evaluation.
- In February 2025, Sagimet released lipidomic findings from its Phase IIb FASCINATE-2 study, focusing on triglycerides and LDL cholesterol in patients with advanced fibrosis. These results will be presented at the Keystone Symposium on MASH Pathogenesis and Therapeutics. Additionally, the US FDA granted denifanstat Breakthrough Therapy and Fast Track designations for non-cirrhotic MASH with moderate to advanced fibrosis.
- Madrigal Pharmaceuticals plans to introduce REZDIFFRA in Europe - starting with Germany - in the second half of 2025, pending EMA authorization, which would make it the first approved therapy for MASH-associated liver fibrosis in the region. Updated two-year MAESTRO-NAFLD-1 data released in February 2025 show potential clinical benefits in patients with compensated MASH cirrhosis, expanding its therapeutic relevance.
- In January 2025, Akero Therapeutics confirmed the completion of patient enrollment in the Phase III SYNCHRONY Real-World trial for MASH/MASLD (F1–F4). Study results are anticipated in the first half of 2026.
- Also in January 2025, the company reaffirmed its strong progress in ongoing Phase III MASH programs. It aims to share topline findings from its first Phase III study by late 2025. Two additional Phase III trials - ENLIGHTEN-Fibrosis for non-cirrhotic MASH (F2–F3) and ENLIGHTEN-Cirrhosis for compensated MASH cirrhosis (F4) - are currently enrolling patients globally.
- In December 2024, Galectin Therapeutics reported outcomes from the NAVIGATE global clinical study assessing belapectin in individuals with MASH cirrhosis accompanied by portal hypertension.
- In October 2024, PharmaIN Corporation announced plans to share interim data from its Phase I clinical trial of PHIN-214, its lead candidate targeted at preventing and treating decompensated cirrhosis.
- In June 2024, Resolution Therapeutics, in collaboration with the University of Edinburgh, presented pivotal RTX001 data at the EASL Congress 2024 in Milan, underscoring the strong potential of macrophage cell therapy in managing advanced liver cirrhosis.
- In June 2024, Lipocine showcased Phase II results of 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 participant in its Phase IIa trial studying an innovative allogeneic regenerative cell therapy delivered into lymph nodes as a potential treatment for end-stage liver disease (ESLD).
- In March 2024, Lipocine reported positive topline findings from its Phase II clinical trial of LPCN 1148, an oral candidate being developed for the therapeutic management of liver cirrhosis.
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Liver Cirrhosis Overview
Liver cirrhosis is a late-stage, progressive liver condition characterized by extensive scarring (fibrosis) that develops after long-term liver damage. Common causes include chronic alcohol use, viral hepatitis (HBV and HCV), nonalcoholic fatty liver disease (NAFLD/MASH), and metabolic disorders. As healthy liver tissue is replaced by scar tissue, blood flow through the liver becomes restricted, impairing essential functions such as detoxification, metabolism, and nutrient processing. Symptoms may range from fatigue and jaundice to complications like ascites, variceal bleeding, and hepatic encephalopathy. Without timely intervention, cirrhosis can progress to liver failure, requiring transplantation in severe cases.
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Liver Cirrhosis Competitive Landscape Assessment
The liver cirrhosis pipeline report proffers an integral view of the emerging liver cirrhosis therapies segmented by stage, product type, molecule 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
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Scope of the Liver Cirrhosis Pipeline Report
- Coverage: Global
- Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
- Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
- Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal
- Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule
- Therapeutics Assessment By Mechanism of Action: Sodium-bile acid cotransporter inhibitors, Regulatory T-lymphocyte stimulants, Ammonia scavengers, DNA gyrase inhibitors, DNA topoisomerase inhibitors, DNA-directed RNA polymerase inhibitors, Beta-catenin inhibitors, CREB-binding protein inhibitors, Wnt signalling pathway inhibitors, Bacteria replacements, Microbiome modulators
- Key Liver Cirrhosis 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, and others.
- Key Liver Cirrhosis 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
1. Liver Cirrhosis Pipeline Report Introduction
2. Liver Cirrhosis Pipeline Report Executive Summary
3. Liver Cirrhosis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Liver Cirrhosis Clinical Trial Therapeutics
6. Liver Cirrhosis Pipeline: Late-Stage Products (Pre-registration)
7. Liver Cirrhosis Pipeline: Late-Stage Products (Phase III)
8. Liver Cirrhosis Pipeline: Mid-Stage Products (Phase II)
9. Liver Cirrhosis Pipeline: Early-Stage Products (Phase I)
10. Liver Cirrhosis Pipeline Therapeutics Assessment
11. Inactive Products in the Liver Cirrhosis Pipeline
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products in the Liver Cirrhosis Pipeline
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix
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.
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