Liver Fibrosis Clinical Trials Analysis 2025: Antifibrotic Agents, Gene Modulators, and Combination Therapies Aim to Reverse Liver Damage and Improve Function | DelveInsight

DelveInsight's "Liver Fibrosis - Clinical Trials Analysis, 2025" outlines a rapidly evolving development landscape with two main objectives: (1) halt or reverse hepatic fibrosis progression, and (2) restore liver function and reduce risk of cirrhosis or liver-related complications. Current programs include small-molecule antifibrotics targeting TGF-β, FXR, and CCR2/CCR5 pathways, biologics aimed at inflammation and stellate cell activation, and emerging gene- and RNA-based therapies designed for durable anti-fibrotic effects.

Late-stage and pivotal trials focus on fibrosis regression, liver stiffness measurements, serum biomarkers (ALT, AST, ELF score), histologic improvement, and clinical outcomes such as progression to cirrhosis or hepatic decompensation. Combination therapies, often pairing antifibrotics with metabolic or antiviral agents, are also under study to enhance efficacy.

Regulatory momentum is growing, with several candidates advancing to Phase III and potential approvals expected in the near term. Standardized endpoints, non-invasive biomarkers, and patient-reported outcomes are increasingly integrated into late-phase trials to demonstrate meaningful liver health improvements and long-term functional benefit.

Interested in learning more about the current treatment landscape and the key drivers shaping the liver fibrosis pipeline? Click here: https://www.delveinsight.com/report-store/liver-fibrosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Liver Fibrosis Pipeline Report
• DelveInsight's liver fibrosis pipeline analysis depicts a strong space with 50+ active players working to develop 55r+ pipeline drugs for liver fibrosis treatment.
• The leading liver fibrosis companies include Inventiva Pharma, Galmed Pharmaceuticals, Clovis Oncology, Novartis, Hepion Pharmaceuticals, Kowa Pharmaceutical, Zedira GmbH, Pfizer, Beijing Continent Pharmaceutical, Zydus Therapeutics, TaiwanJ Pharmaceuticals, HEC Pharm, Genoscience, Ark Biosciences, and others are evaluating their lead assets to improve the liver fibrosis treatment landscape.
• Key liver fibrosis pipeline therapies in various stages of development include Lanifibranor, Aramchol meglumine, FAP-2286, Tropifexor, Rencofilstat, K-877-ER, ZED1227, PF-07202954, Hydronidone, Saroglitazar Magnesium, JKB-122, Yifenidone, GNS-561, AK 3280, and others.
• In August 2025, the FDA granted accelerated approval to WEGOVY (semaglutide 2.4 mg) for treating noncirrhotic MASH with moderate to advanced liver fibrosis (F2-F3). Approval was based on the ESSENCE trial, where WEGOVY improved fibrosis and resolved steatohepatitis without worsening disease.
• In May 2025, Roche announced the launch of its ELECSYS PRO-C3 test, a new diagnostic solution designed to assess the severity of liver fibrosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Developed in collaboration with Nordic Bioscience, the test provides clinicians with a simple and efficient way to identify patients with liver fibrosis of varying severity, facilitating timely intervention and management of the disease.
• In November 2024, Novo Nordisk announced positive results for semaglutide in treating metabolic dysfunction-associated steatohepatitis (MASH). In the Phase III Essence trial, a once-weekly 2.4 mg dose of semaglutide improved liver fibrosis and resolved steatohepatitis without worsening liver fibrosis in MASH patients with stage 2 or stage 3 fibrosis, meeting the primary endpoints.
• In October 2024, the FDA granted Breakthrough Therapy designation to survodutide (BI 456906), a dual glucagon/GLP-1 receptor agonist, for treating adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced fibrosis (stages 2 or 3). This follows promising Phase II results. Boehringer Ingelheim also launched two Phase III studies: LIVERAGE, for MASH patients with fibrosis, and LIVERAGE-Cirrhosis, for those with MASH and cirrhosis.

Request a sample and discover the recent breakthroughs happening in the liver fibrosis pipeline landscape at https://www.delveinsight.com/report-store/liver-fibrosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Liver Fibrosis Overview
Liver fibrosis is a progressive condition marked by excessive buildup of extracellular matrix proteins, particularly collagen, in response to chronic liver injury from causes such as viral hepatitis (HBV, HCV), alcohol abuse, NAFLD, or autoimmune diseases. Early stages are often asymptomatic, making diagnosis difficult until significant damage occurs, with later symptoms including fatigue, weight loss, abdominal pain, and mild jaundice. In advanced cases, complications like portal hypertension, ascites, and variceal bleeding may develop. The condition is driven by the activation of hepatic stellate cells, which, under the influence of inflammatory signals, transform into collagen-producing myofibroblast-like cells, disrupting liver structure and function. While early fibrosis may be reversible, ongoing injury can lead to irreversible cirrhosis, liver failure, or hepatocellular carcinoma.

Find out more about liver fibrosis medication at https://www.delveinsight.com/report-store/liver-fibrosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Liver Fibrosis Treatment Analysis: Drug Profile
Aramchol: Galmed Research and Development, Ltd
Aramchol (Arachidyl Amido Cholanoic Acid) is a first-in-class synthetic small molecule, combining Cholic Acid and Arachidic Acid. It is a liver-targeted SCD1 modulator developed as an oral treatment for Nonalcoholic Steatohepatitis (NASH) and fibrosis. Aramchol's ability to modulate hepatic lipid metabolism was established in animal models, showing a reduction in the three primary pathologies of NASH: steatosis, inflammation, and fibrosis. Its effect on fibrosis is mediated by decreasing steatosis and directly targeting collagen-producing cells.

Aramchol operates by elevating fatty acid oxidation (fat burning) in hepatocytes and influencing AMPK, which helps reduce glycemic parameters. In hepatic stellate cells, Aramchol inhibits the activity of stearoyl-CoA desaturase-1 (SCD-1), leading to a direct impact on fibrogenesis. The drug is currently in Phase III development for liver fibrosis treatment.

Belapectin: Galectin Therapeutics
Belapectin is a complex carbohydrate designed to target galectin-3, a key protein involved in the pathogenesis of NASH and fibrosis. Galectin-3 plays a significant role in fibrotic disorders of various organs, including the liver, lungs, kidneys, heart, and vascular system. Belapectin binds to and disrupts galectin-3's function. Preclinical animal studies have demonstrated that belapectin can effectively reverse liver fibrosis and cirrhosis. The drug is currently in Phase II/III development for liver fibrosis treatment.

AZD2693: AstraZeneca
AZD2693 is a liver-targeted antisense oligonucleotide that targets PNPLA3 mRNA. By reducing PNPLA3 expression in homozygotes for the 148M risk allele, AZD2693 aims to tackle a major driver of NASH. Preclinical studies have shown typical class effects of antisense oligonucleotides (ASOs), including histiocytic infiltration in multiple tissues and accumulation in the liver and spleen, with no adverse effects linked to PNPLA3 reduction. Additional safety pharmacology studies revealed no impact on the respiratory, cardiovascular, or nervous systems. In preclinical pharmacology studies, AZD2693 has reduced liver steatosis, inflammation, and fibrosis in PNPLA3 148M knock-in mice. The drug is currently in Phase II development for liver fibrosis treatment.

Learn more about the novel and emerging liver fibrosis pipeline therapies at https://www.delveinsight.com/report-store/liver-fibrosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Liver Fibrosis Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intravenous
• Subcutaneous
• Oral
• Intramuscular

By Molecule Type
• Monoclonal antibody
• Small molecule
• Peptide

Scope of the Liver Fibrosis Pipeline Report
• Coverage: Global
• Key Liver Fibrosis Companies: Inventiva Pharma, Galmed Pharmaceuticals, Clovis Oncology, Novartis, Hepion Pharmaceuticals, Kowa Pharmaceutical, Zedira GmbH, Pfizer, Beijing Continent Pharmaceutical, Zydus Therapeutics Inc., TaiwanJ Pharmaceuticals, HEC Pharm, Genoscience, Ark Biosciences, and others.
• Key Liver Fibrosis Pipeline Therapies: Lanifibranor, Aramchol meglumine, FAP-2286, Tropifexor, Rencofilstat, K-877-ER, ZED1227, PF-07202954, Hydronidone, Saroglitazar Magnesium, JKB-122, Yifenidone, GNS-561, AK 3280, and others.

Dive deep into rich insights for drugs used for liver fibrosis treatment, visit: https://www.delveinsight.com/report-store/liver-fibrosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Liver Fibrosis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Liver Fibrosis Pipeline Therapeutics
6. Liver Fibrosis Pipeline: Late-Stage Products (Phase III)
7. Liver Fibrosis Pipeline: Mid-Stage Products (Phase II)
8. Liver Fibrosis Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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Jatin Vimal
jvimal@delveinsight.com
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Healthcare Consulting
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