liver fibrosis pipeline insight

DelveInsight’s, “Liver Fibrosis- Pipeline Insight, 2025” report provides comprehensive insights about 50+ companies and 55+ pipeline drugs in Liver Fibrosis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

 

Geography Covered

• Global coverage

 

Liver Fibrosis: Understanding

Liver Fibrosis: Overview

Liver fibrosis is the excessive accumulation of extracellular matrix proteins, including collagen, in the liver due to chronic injury. It is a progressive condition that results from sustained inflammation and hepatocyte damage, often caused by chronic viral hepatitis (HBV, HCV), alcohol abuse, non-alcoholic fatty liver disease (NAFLD), or autoimmune liver diseases. While early-stage fibrosis may be reversible, advanced fibrosis can progress to cirrhosis, liver failure, and hepatocellular carcinoma (HCC).

 

The signs and symptoms of liver fibrosis are often nonspecific in the early stages, making it difficult to diagnose. Many patients remain asymptomatic until significant liver damage has occurred. As fibrosis progresses, individuals may experience fatigue, unexplained weight loss, abdominal discomfort, and mild jaundice. In more advanced stages, complications such as portal hypertension, ascites, splenomegaly, and variceal bleeding may develop.

 

Pathophysiologically, liver fibrosis occurs due to the activation of hepatic stellate cells (HSCs) in response to liver injury. These cells, usually in a quiescent state, transform into myofibroblast-like cells under the influence of pro-inflammatory cytokines, growth factors (e.g., TGF-β), and oxidative stress. This leads to excessive deposition of collagen and disruption of the normal liver architecture, impairing blood flow and hepatocyte function. If the underlying cause persists, fibrosis can become irreversible, leading to cirrhosis.

 

Diagnosis of liver fibrosis involves a combination of clinical assessment, laboratory tests, imaging, and sometimes liver biopsy. Blood tests such as the AST-to-platelet ratio index (APRI) and Fibrosis-4 (FIB-4) score provide noninvasive markers of fibrosis. Imaging techniques like transient elastography (FibroScan) and magnetic resonance elastography (MRE) assess liver stiffness. Liver biopsy remains the gold standard but is used selectively due to its invasiveness.

 

Treatment focuses on addressing the underlying cause of fibrosis to prevent progression. For viral hepatitis, antiviral therapies (e.g., direct-acting antivirals for HCV) are effective. In NAFLD, lifestyle modifications, weight loss, and metabolic control are key. Antifibrotic agents, though under research, show promise in targeting fibrotic pathways. In severe cases, liver transplantation may be the only option. Early detection and intervention are crucial to improving prognosis and preventing cirrhosis-related complications.

 

"Liver Fibrosis- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Liver Fibrosis pipeline landscape is provided which includes the disease overview and Liver Fibrosis treatment guidelines. The assessment part of the report embraces, in depth Liver Fibrosis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Liver Fibrosis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

 

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Liver Fibrosis R&D. The therapies under development are focused on novel approaches to treat/improve Liver Fibrosis. 

 

Liver Fibrosis Emerging Drugs Chapters

This segment of the Liver Fibrosis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

 

Liver Fibrosis Emerging Drugs

• Aramchol: Galmed Research and Development, Ltd

Aramchol (Arachidyl Amido Cholanoic Acid) is a first-in-class, novel synthetic small molecule, a conjugate of Cholic Acid and Arachidic Acid, liver targeted SCD1 modulator, developed as an oral therapy for the treatment of NASH (Nonalcoholic Steatohepatitis) and fibrosis. Aramchol’s ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation, and fibrosis. The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells.

Aramchol, by targeting this single receptor, induces a cascade of events that leads to two main changes; in hepatocytes, Aramchol elevates the fatty acids oxidation (or in other words – fat burn) and influences AMPK, which results also in reducing glycemic parameters; and in hepatic stellate cells, Aramchol has been shown to down-regulate the expression and activity of stearoyl-CoA desaturase-1 (SCD-1), resulting in a direct effect on fibrogenesis. Currently, the drug is in the Phase III stage of its development for the treatment of Liver Fibrosis

 

• Belapectin: Galectin Therapeutics

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. Currently, the drug is in Phase II/III stage of development for the treatment of liver fibrosis.

 

• AZD2693: AstraZeneca

AZD2693 is a liver-targeted antisense oligonucleotide against PNPLA3 mRNA. AZD2693 lowers the mRNA expression of PNPLA3 in patients that are homozygotes for the 148M risk allele thereby reducing an important disease driver for NASH. AZD2693 has been evaluated in 3-month repeat dose subcutaneous toxicity study in preclinical species. Findings were consistent with typical class effects of ASOs, including histiocytic infiltration in multiple tissues and evidence of ASO accumulation in liver and spleen. No effects were attributed to the reduction in PNPLA3.

Preclinical safety pharmacology studies have also been conducted with no effects on the respiratory, cardiovascular, and central and peripheral nervous systems. Under preclinical pharmacology, Murine PNPLA3 tool ASO has been shown to reduce liver steatosis, inflammation and fibrosis in homozygous PNPLA3 148M knock-in mice. Currently, the drug is in the Phase II stage of its development for the treatment of Liver Fibrosis.

 

• RTX001: Resolution Therapeutics

RTX001 is an engineered, autologous regenerative macrophage therapy with enhanced anti-fibrotic and anti-inflammatory effect. The product candidate is engineered with IL-10-MMP9 mRNA to enhance the natural regenerative properties of macrophages for superior efficacy and durability. RTX001 is an innovative medical treatment being studied for patients with decompensated liver cirrhosis. It is classified as an autologous macrophage therapy, which means it uses the patient’s own immune cells to potentially treat their condition. RTX001 is administered as a dispersion for infusion, which is a liquid form of the medication that is given directly into the bloodstream through an Intravenous (IV) line.  Currently, the drug is in the Phase I/II stage of its development for the treatment of Liver Fibrosis

 

• AD-214: AdAlta

AD-214 is AdAlta's lead drug candidate, an Fc-fusion protein that combines anti-body with the Fc fragment of a traditional monoclonal antibody to extend its duration in the body. AD-214 binds to the CXCR4 receptor on target diseased cells, exerting anti-inflammatory and anti-fibrotic effects without impacting healthy cells. It has demonstrated efficacy in animal models of fibrosis and is being explored for the treatment of liver fibrosis. Currently, the drug is in Preclinical stage of its clinical trial for the treatment of liver fibrosis.

Further product details are provided in the report……..

 

Liver Fibrosis: Therapeutic Assessment

This segment of the report provides insights about the different Liver Fibrosis drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Liver Fibrosis

There are approx. 50+ key companies which are developing the therapies for Liver Fibrosis. The companies which have their Liver Fibrosis drug candidates in the most advanced stage, i.e. Phase III include, Galmed Research and Development, Ltd

 

Phases

DelveInsight’s report covers around 55+ products under different phases of clinical development like

• 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

 

Route of Administration

Liver Fibrosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as 

• Intravenous
• Subcutaneous
• Oral
• Intramuscular

 

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide

 

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

 

Liver Fibrosis: Pipeline Development Activities 

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Liver Fibrosis therapeutic drugs key players involved in developing key drugs. 

 

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Liver Fibrosis drugs.

 

Liver Fibrosis Report Insights

• Liver Fibrosis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

 

Liver Fibrosis Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

 

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Liver Fibrosis drugs?
• How many Liver Fibrosis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Liver Fibrosis?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Liver Fibrosis therapeutics? 
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? 
• What are the clinical studies going on for Liver Fibrosis and their status?
• What are the key designations that have been granted to the emerging drugs?