Liver Cirrhosis Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, Treatment Market, Mechanism of Action, Route of Administration, and Companies by DelveInsight

Liver cirrhosis companies such as Versantis AG, Mirum Pharmaceuticals, Sagimet Biosciences, TenNor Therapeutics, Prism Pharma, Vedanta Biosciences, Lipocine, Gwo Xi Stem Cell Applied Technology, Galectin Therapeutics, Resolution Therapeutics, Ipsen, AstraZeneca, and others.
(Albany, USA) DelveInsight's 'Liver Cirrhosis Pipeline Insight 2025' report provides comprehensive global coverage of pipeline liver cirrhosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the liver cirrhosis pipeline domain.

The liver cirrhosis treatment market is poised for significant growth, driven by the rising global prevalence of liver diseases, particularly NAFLD, fueled by lifestyle factors like obesity, alcohol consumption, and metabolic syndrome. Technological advancements in antiviral therapies and regenerative medicine are enhancing treatment outcomes, while an aging population further increases demand. These factors collectively highlight a strong growth trajectory for the market.

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Key Takeaways from the Liver Cirrhosis Pipeline Report

* DelveInsight's liver cirrhosis pipeline report depicts a robust space with 30+ active players working to develop 30+ pipeline liver cirrhosis drugs.
* Key liver cirrhosis companies such as Versantis AG, Mirum Pharmaceuticals, Sagimet Biosciences, TenNor Therapeutics, Prism Pharma, Vedanta Biosciences, Lipocine, Gwo Xi Stem Cell Applied Technology, Galectin Therapeutics, Resolution Therapeutics, Ipsen, AstraZeneca, and others are evaluating new liver cirrhosis drugs to improve the treatment landscape.
* Promising pipeline liver cirrhosis therapies such as Volixibat, VS-01, TVB-2640, TNP-2092, PRI-724, VE303, LPCN 1148, GXHPC1, Belapectin, RTX001, Elafibranor, Zibotentan, and others are under different phases of liver cirrhosis clinical trials.
* In February 2025, Sagimet announced lipidomic data from the Phase IIb FASCINATE-2 trial, focusing on triglycerides and LDL cholesterol in advanced fibrosis, which will be presented at the MASH Pathogenesis and Therapeutic Approaches Keystone Symposium. The US FDA granted denifanstat Breakthrough Therapy (BTD) and Fast Track Designation (FTD) for non-cirrhotic MASH with moderate to advanced fibrosis.
* Madrigal Pharmaceuticals aims to roll out REZDIFFRA across Europe starting with Germany in the second half of 2025, pending EMA approval for REZDIFFRA, making it the first authorized therapy for MASH-related liver fibrosis in the region. Furthermore, updated two-year data from the MAESTRO-NAFLD-1 trial, released in February 2025, indicate possible benefits for patients with compensated MASH cirrhosis, suggesting an expanded scope of clinical effectiveness.
* In January 2025, Akero Therapeutics announced the completion of patient enrollment in the Phase III SYNCHRONY Real-World study for MASH or MASLD (F1-F4), with results expected in the first half of 2026.
* In January 2025, the company emphasized its strong position for the year, with ongoing Phase III trials in MASH. It expects to release topline data from its first Phase III trial in late 2025. The company is also conducting two Phase III trials-ENLIGHTEN-Fibrosis for non-cirrhotic MASH (F2-F3) patients and ENLIGHTEN-Cirrhosis for compensated cirrhotic MASH (F4) patients-both of which are actively enrolling global patients.
* In December 2024, Galectin Therapeutics announced results from its global clinical trial NAVIGATE evaluating belapectin in patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis and portal hypertension.
* In October 2024, PharmaIN Corporation announced the company will present interim results from its ongoing Phase I clinical trial of PHIN-214, the company's lead candidate, for the prevention and treatment of decompensated cirrhosis.
* In June 2024, Resolution Therapeutics Limited announced key data presentations of RTX001 with the University of Edinburgh at the EASL Congress 2024, held in Milan, Italy which demonstrate the significant potential of macrophage cell therapy as a treatment for advanced liver cirrhosis.
* In June 2024, Lipocine announced that Phase II results on LPCN 1148 in cirrhosis were featured in a late breaking oral presentation at the European Association for the Study of Liver (EASL) Congress in Milan, Italy.
* In April 2024, LyGenesis announced that the first patient had been dosed in their Phase IIa clinical trial evaluating their first-in-class allogenic regenerative cell therapy transplanted into patients' lymph nodes as a potential treatment for end-stage liver disease (ESLD).
* In March 2024, Lipocine announced positive topline results from a Phase II clinical study of LPCN 1148. LPCN 1148 is an oral candidate under development for the clinical management of liver cirrhosis.

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Liver Cirrhosis Overview

Liver cirrhosis is a condition where the liver becomes scarred and permanently damaged, with healthy liver tissue replaced by scar tissue, impairing its normal function. It often results from long-term liver damage caused by conditions like alcohol-related liver disease, nonalcoholic fatty liver disease, chronic hepatitis C, and chronic hepatitis B. Symptoms may not be noticeable until significant liver damage occurs and can include fatigue, severe itching, and swelling in the legs and abdomen. Doctors diagnose cirrhosis through a combination of medical history, physical examination, and tests such as blood work, imaging, and liver biopsy. While there is no definitive cure, addressing the underlying causes can slow disease progression and reduce the risk of liver failure. Complications may include portal hypertension, infections, and liver cancer. Managing cirrhosis involves eating a healthy diet, avoiding alcohol and liver-damaging foods like raw shellfish, and, in severe cases, considering a liver transplant.

The symptoms of liver cirrhosis can vary based on its severity. Early signs include fatigue, poor appetite, weight loss, nausea, abdominal pain, and spider-like red blood vessels on the skin. As the condition worsens, symptoms may include fluid buildup in the legs and abdomen, yellowing of the skin and eyes (jaundice), redness on the palms, easy bruising, abnormal bleeding, confusion or difficulty thinking, pale stools, and gastrointestinal bleeding.

Diagnosing liver cirrhosis involves blood tests, imaging studies, and, sometimes, a liver biopsy. Blood tests can identify elevated liver enzymes, abnormal liver function, or signs of inflammation or infection. Imaging techniques such as ultrasound, CT scans, or MRIs can reveal liver abnormalities, while a biopsy can confirm the diagnosis and evaluate the extent of damage.

Treatment focuses on slowing scar tissue formation, managing symptoms, and preventing complications. Lifestyle changes may include a healthy diet, stopping alcohol consumption, weight loss for obese individuals, regular exercise, and maintaining good hygiene to lower infection risks. Medications may include antivirals for hepatitis, diuretics to reduce fluid retention, beta-blockers to prevent bleeding from enlarged veins, and creams to relieve itching.

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Liver Cirrhosis Therapeutics 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: Versantis AG, Mirum Pharmaceuticals, Sagimet Biosciences, TenNor Therapeutics, Prism Pharma, Vedanta Biosciences, Intercept Pharmaceuticals, Boehringer Ingelheim, Ohara Pharmaceutical, Ocelot Bio, Calliditas Therapeutics, Galecto Biotech, Pharmicell, 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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