Liver Cirrhosis Pipeline 2025: FDA Updates, Therapy Innovations, and Clinical Trial Landscape Analysis

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Liver Cirrhosis pipeline constitutes 30+ key companies continuously working towards developing 30+ Liver Cirrhosis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Liver Cirrhosis Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Liver Cirrhosis Market.

The Liver Cirrhosis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Liver Cirrhosis Pipeline Report: https://www.delveinsight.com/sample-request/liver-cirrhosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Liver Cirrhosis treatment therapies with a considerable amount of success over the years.
• Liver Cirrhosis companies working in the treatment market are PharmaIN, Gwo Xi Stem Cell Applied Technology Co., Ltd., Lipocine Inc., Calliditas Therapeutics, Galectin Therapeutics, Zydus Therapeutics, CymaBay Therapeutics, and others, are developing therapies for the Liver Cirrhosis treatment
• Emerging Liver Cirrhosis therapies in the different phases of clinical trials are- PHIN-214, GXHPC1, LPCN 1148, Setanaxib, Belapectin, Saroglitazar, Seladelpar, and others are expected to have a significant impact on the Liver Cirrhosis market in the coming years.
• In August 2025, Zydus Therapeutics, a unit of Zydus Lifesciences, announced that its experimental drug Saroglitazar delivered positive outcomes in a late-stage clinical trial for primary biliary cholangitis (PBC), a rare chronic liver disorder. The company stated it intends to submit an application for USFDA approval in the first quarter of 2026. Notably, Saroglitazar has already been available in India since 2020 for the treatment of non-alcoholic fatty liver disease (NAFLD) and its advanced stage, non-alcoholic steatohepatitis (NASH).
• In August 2025, The European Union (EU) has granted conditional approval to Rezdiffra (resmetirom) for certain patients with metabolic dysfunction-associated steatohepatitis (MASH), marking it as the first authorized treatment for this serious fatty liver disease. The European Commission's (EC) decision allows access to the drug for individuals with MASH who have moderate to advanced liver fibrosis that has not yet progressed to permanent damage. This conditional marketing authorization extends across all EU member states as well as Iceland, Liechtenstein, and Norway.
• In August 2025, The FDA has granted approval for Wegovy, a GLP-1 medication for obesity, to also be used in treating metabolic dysfunction-associated steatohepatitis (MASH), a serious liver condition. Novo Nordisk, the drug's manufacturer, received accelerated approval for its use in patients with moderate to advanced liver fibrosis, in combination with a reduced-calorie diet and increased physical activity. With this decision, Wegovy becomes the second FDA-approved therapy for MASH-related fibrosis.
• In April 2025, Enrollment has been finalized for the Phase 3 NATiV3 clinical trial (NCT04849728), which is evaluating lanifibranor in individuals with metabolic dysfunction-associated steatohepatitis (MASH) and advanced liver fibrosis. According to the developer, Inventiva, if the results are favorable, the top-line data from this global study could support regulatory approval submissions for lanifibranor.
• In March 2025, According to two-year data from the Phase 3 MAESTRO-NAFLD-1 clinical trial (NCT04197479), long-term treatment with Rezdiffra (resmetirom) has been shown to reduce liver scarring in most individuals with compensated cirrhosis-irreversible scarring in a still-functioning liver-caused by metabolic dysfunction-associated steatohepatitis (MASH). This finding was recently revealed by Madrigal Pharmaceuticals, the developer of the therapy.
• In March 2025, Akero Therapeutics' experimental therapy efruxifermin has shown the ability to reverse compensated cirrhosis-permanent liver scarring with preserved function-in adults with metabolic dysfunction-associated steatohepatitis (MASH), a serious form of fatty liver disease. These top-line results come from the Phase 2b SYMMETRY clinical trial (NCT05039450) and were described by the company as both "unprecedented" and statistically significant in a recent press release. The findings align with previous Phase 2b HARMONY trial (NCT04767529) data, which demonstrated that efruxifermin reduced liver fibrosis in patients with MASH who had not yet developed cirrhosis.
• In January 2025, Akero Therapeutics has announced preliminary topline results from week 96 of its Phase IIb SYMMETRY study evaluating efruxifermin (EFX) in adults with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, caused by metabolic dysfunction-associated steatohepatitis (MASH). This placebo-controlled, multicenter, double-blind, dose-ranging, randomized trial focused on individuals with the condition.
• In December 2024, Galectin Therapeutics revealed findings from its global NAVIGATE clinical trial assessing belapectin in individuals with Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis and portal hypertension.
• In October 2024, PharmaIN Corporation announced that it will present interim findings from its ongoing Phase I clinical trial of PHIN-214, its leading candidate for preventing and treating decompensated cirrhosis.
• In June 2024, Resolution Therapeutics Limited, in collaboration with the University of Edinburgh, presented key data on RTX001 at the EASL Congress 2024 in Milan, Italy, highlighting the promising potential of macrophage cell therapy for treating advanced liver cirrhosis.
• In June 2024, Lipocine announced that Phase II findings on LPCN 1148 in cirrhosis were showcased in a late-breaking oral presentation at the EASL Congress 2024 in Milan, Italy.
• In April 2024, LyGenesis announced that the first patient has received a dose in their Phase IIa clinical trial assessing their innovative allogenic regenerative cell therapy, transplanted into lymph nodes, as a potential treatment for end-stage liver disease (ESLD).
• In March 2024, Lipocine reported positive topline results from a Phase II clinical trial of LPCN 1148, an oral therapy in development for managing liver cirrhosis.

Liver Cirrhosis Overview
Liver Cirrhosis is a chronic liver disease marked by scarring (fibrosis) of liver tissue due to long-term damage. It occurs when healthy liver cells are replaced by scar tissue, which interferes with the liver's ability to function properly. Common causes include chronic alcohol use, hepatitis B or C infections, and non-alcoholic fatty liver disease (NAFLD). Symptoms may include fatigue, jaundice, easy bruising, swelling, and confusion. As the disease progresses, it can lead to liver failure or liver cancer. While the damage is usually irreversible, early diagnosis and treatment can slow progression and manage complications.

Get a Free Sample PDF Report to know more about Liver Cirrhosis Pipeline Therapeutic Assessment-
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Emerging Liver Cirrhosis Drugs Under Different Phases of Clinical Development Include:
• PHIN-214: PharmaIN
• GXHPC1: Gwo Xi Stem Cell Applied Technology Co., Ltd.
• LPCN 1148: Lipocine Inc.
• Setanaxib: Calliditas Therapeutics
• Belapectin: Galectin Therapeutics
• Saroglitazar: Zydus Therapeutics
• Seladelpar: CymaBay Therapeutics

Liver Cirrhosis Route of Administration
Liver Cirrhosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
• Inhalation
• Inhalation/Intravenous/Oral
• Intranasal
• Intravenous
• Intravenous/ Subcutaneous
• NA
• Oral
• Oral/intranasal/subcutaneous
• Parenteral
• Subcutaneous

Liver Cirrhosis Molecule Type
Liver Cirrhosis Products have been categorized under various Molecule types, such as
• Antibody
• Antisense oligonucleotides
• Immunotherapy
• Monoclonal antibody
• Peptides
• Protein
• Recombinant protein
• Small molecule
• Stem Cell
• Vaccine

Liver Cirrhosis Pipeline Therapeutics Assessment
• Liver Cirrhosis Assessment by Product Type
• Liver Cirrhosis By Stage and Product Type
• Liver Cirrhosis Assessment by Route of Administration
• Liver Cirrhosis By Stage and Route of Administration
• Liver Cirrhosis Assessment by Molecule Type
• Liver Cirrhosis by Stage and Molecule Type

DelveInsight's Liver Cirrhosis Report covers around 30+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Liver Cirrhosis product details are provided in the report. Download the Liver Cirrhosis pipeline report to learn more about the emerging Liver Cirrhosis therapies
https://www.delveinsight.com/sample-request/liver-cirrhosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key companies in the Liver Cirrhosis Therapeutics Market include:
Key companies developing therapies for Liver Cirrhosis are - Astrazeneca, Bayer, Sanofi, Pfizer, Merck & Co., Novartis, Hoffmann-La Roche, Takeda, Gilead Sciences, Shionogi Inc., Promethera, and others.

Liver Cirrhosis Pipeline Analysis:
The Liver Cirrhosis pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Liver Cirrhosis with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Liver Cirrhosis Treatment.
• Liver Cirrhosis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Liver Cirrhosis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Liver Cirrhosis market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Liver Cirrhosis drugs and therapies
https://www.delveinsight.com/sample-request/liver-cirrhosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Liver Cirrhosis Pipeline Market Drivers
• Increasing Prevalence for the treatment of Liver Cirrhosis, increase in the growing government initiatives and rising awareness are some of the important factors that are fueling the Liver Cirrhosis Market.

Liver Cirrhosis Pipeline Market Barriers
• However, side-effects associated with the treatment of Liver Cirrhosis, high cost associated with the treatment and other factors are creating obstacles in the Liver Cirrhosis Market growth.

Scope of Liver Cirrhosis Pipeline Drug Insight
• Coverage: Global
• Key Liver Cirrhosis Companies: PharmaIN, Gwo Xi Stem Cell Applied Technology Co., Ltd., Lipocine Inc., Calliditas Therapeutics, Galectin Therapeutics, Zydus Therapeutics, CymaBay Therapeutics, and others
• Key Liver Cirrhosis Therapies: PHIN-214, GXHPC1, LPCN 1148, Setanaxib, Belapectin, Saroglitazar, Seladelpar, and others
• Liver Cirrhosis Therapeutic Assessment: Liver Cirrhosis current marketed and Liver Cirrhosis emerging therapies
• Liver Cirrhosis Market Dynamics: Liver Cirrhosis market drivers and Liver Cirrhosis market barriers

Contact Us:
Gaurav Bora
gbora@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

This release was published on openPR.