Liver Fibrosis Pipeline: 50+ Companies Advancing Antifibrotic Therapies and Disease-Modifying Strategies Redefining Liver Fibrosis Treatment | DelveInsight

The therapeutic landscape for liver fibrosis, a pathological scarring process resulting from chronic liver injury, is rapidly evolving, as biopharmaceutical innovators shift their focus from symptomatic control to targeting the fibrogenic mechanisms driving disease progression. With no FDA-approved treatments specifically for reversing liver fibrosis, the spotlight is now on antifibrotic agents, inflammation modulators, and regenerative therapies aimed at halting or reversing fibrotic damage before it advances to liver fibrosis. Companies such as Inventiva Pharma, Galmed Pharmaceuticals, Clovis Oncology, Novartis, and Hepion Pharmaceuticals are at the forefront, developing candidates that interfere with fibrotic signaling, reduce hepatic stellate cell activation, and restore liver homeostasis.

DelveInsight's "Liver Fibrosis - Pipeline Insight, 2025" offers a comprehensive analysis of the global R&D landscape, profiling clinical and preclinical drug candidates with novel mechanisms of action. The report covers a wide range of innovative approaches, including FXR agonists, galectin-3 inhibitors, LOXL2 inhibitors, CCR2/CCR5 antagonists, and combination strategies targeting multiple fibrotic pathways. It also explores drug delivery innovations, biomarker-led trial designs, regulatory designations, and strategic collaborations shaping the pipeline. As liver fibrosis remains a major contributor to the chronic liver disease burden worldwide, this report highlights the emerging therapies poised to transform its management and offer hope for disease modification.

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 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.

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Liver Fibrosis Overview
Liver fibrosis is characterized by the excessive buildup of extracellular matrix proteins, including collagen, in the liver, typically due to chronic liver injury. It progresses as a result of prolonged inflammation and liver cell damage, often caused by factors like chronic viral hepatitis (HBV, HCV), alcohol abuse, non-alcoholic fatty liver disease (NAFLD), or autoimmune liver diseases. While early fibrosis may be reversible, advanced stages can lead to cirrhosis, liver failure, and hepatocellular carcinoma (HCC).

In the early stages, liver fibrosis often has few or no symptoms, making it challenging to diagnose. Many individuals remain asymptomatic until significant liver damage occurs. As the disease advances, symptoms like fatigue, unexplained weight loss, abdominal pain, and mild jaundice may emerge. In severe cases, complications such as portal hypertension, ascites, splenomegaly, and variceal bleeding can arise.

The pathophysiology of liver fibrosis involves the activation of hepatic stellate cells (HSCs) in response to liver injury. These cells, normally inactive, transform into myofibroblast-like cells under the influence of inflammatory cytokines, growth factors (such as TGF-β), and oxidative stress, leading to excessive collagen deposition and disruption of the liver's architecture. If the injury persists, the fibrosis can become irreversible, eventually progressing to cirrhosis.

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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