Cirrhosis Pipeline: Novel Antifibrotic Therapies and Regenerative Approaches Redefining Cirrhosis Treatment | DelveInsight

The treatment landscape for cirrhosis, a progressive liver condition marked by fibrosis and compromised liver function, is witnessing a transformative shift as biopharmaceutical companies advance beyond symptomatic management to target the underlying causes of liver damage. With no approved therapies to reverse established fibrosis, there is a growing focus on antifibrotic agents, hepatoprotective compounds, and regenerative therapies that aim to halt or reverse disease progression. Companies like Ocera Therapeutics, Gilead Sciences, Chia Tai Tianqing Pharmaceutical Group, Zydus Cadila, and Novartis Pharmaceuticals are leading the charge with innovative therapies targeting fibrosis pathways, immune modulation, and liver regeneration.

DelveInsight's "Cirrhosis - Pipeline Insight, 2025" delivers an in-depth analysis of the global R&D landscape, covering clinical and preclinical-stage drugs with novel mechanisms of action. The report highlights promising candidates including FXR agonists, integrin inhibitors, CCR2/CCR5 antagonists, and stem cell-based interventions, offering hope for disease modification. Additionally, it provides insights into formulation advancements, administration routes, biomarker-guided approaches, regulatory incentives, and strategic partnerships driving innovation. As the burden of cirrhosis grows globally, this report captures the emerging therapeutic solutions poised to reshape its future management.

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

Key Takeaways from the Cirrhosis Pipeline Report
• DelveInsight's cirrhosis pipeline analysis depicts a strong space with 50+ active players working to develop 50+ pipeline drugs for cirrhosis treatment.
• The leading cirrhosis companies include GWOXI Stem Cell Applied Technology, Lipocine, Galectin Therapeutics, Pharmicell, BioVie, Ocera Therapeutics, Gilead Sciences, Chia Tai Tianqing Pharmaceutical Group, Zydus Cadila, Novartis Pharmaceuticals, Genfit, PRISM Pharma, Bristol-Myers Squibb, COUR Pharmaceutical Development Company, HighTide Biopharma, Gannex Pharma, and others are evaluating their lead assets to improve the cirrhosis treatment landscape.
• Key cirrhosis pipeline therapies in various stages of development include Belapectin, GXHPC 1, LPCN 1148, Cellgram-LC, BIV-201, Ornithine phenylacetate, CILO, TQA 3526, Saroglitazar, LDE225, Elafibranor, OP-724, BMS 986263, CNP-104, HTD 1801, ASC42, and others.
• In December 2024, Gilead Sciences, Inc.announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for LIVDELZI (seladelpar) to treat primary biliary cholangitis (PBC). The drug is approved for use in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA or as a monotherapy for patients who cannot tolerate UDCA. However, LIVDELZI is not recommended for individuals with or who develop decompensated cirrhosis.
• In December 2024, the FDA granted Fast Track Designation to Lipocine Inc.'s LPCN 1148 for the treatment of sarcopenia in patients with decompensated cirrhosis. LPCN 1148, an oral prodrug of bioidentical testosterone, demonstrated positive results in a proof-of-concept Phase II study, improving sarcopenia and related clinical outcomes. The treatment aims to be a "First in Class" product with a novel mechanism for managing cirrhosis.
• In December 2024, the FDA reported serious liver injury cases in primary biliary cholangitis (PBC) patients treated with obeticholic acid (OCALIVA) who did not have cirrhosis. The FDA's review of a clinical trial showed that patients without cirrhosis had a significantly higher risk of liver injury, including cases requiring a liver transplant, compared to those on a placebo.
• In August 2024, the FDA granted accelerated approval for LIVDELZI (seladelpar) for treating primary biliary cholangitis (PBC). LIVDELZI can be used with ursodeoxycholic acid (UDCA) in adults who don't respond adequately to UDCA, or as a standalone therapy for those intolerant to UDCA. It is not recommended for patients with decompensated cirrhosis.

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Cirrhosis Overview
Cirrhosis is the scarring (fibrosis) of the liver caused by long-term liver damage, where the scar tissue interferes with the liver's normal functioning. Often referred to as end-stage liver disease, cirrhosis occurs after several stages of liver damage from conditions like hepatitis. While cirrhosis is progressive, it can often be prevented, as the underlying diseases tend to advance slowly, and there are treatments available to address them. Preventing cirrhosis also helps reduce the risk of hepatocellular carcinoma (HCC), since most cases of HCC develop in cirrhotic livers.

Cirrhosis can result from a variety of causes, including toxic, infectious, autoimmune, or metabolic factors, as well as vascular issues. Common signs of cirrhosis include skin changes, a firm liver upon palpation, and risk factors like metabolic syndrome, heavy alcohol use, and exposure to liver-damaging substances. Early symptoms may include fatigue, poor appetite, unexplained weight loss, nausea, vomiting, and mild pain or discomfort in the upper right side of the abdomen. While there is no cure for cirrhosis, its symptoms and complications can be managed, and treatments aimed at the underlying causes, such as antiviral medications for hepatitis C, can help prevent further liver damage.

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Cirrhosis Treatment Analysis: Drug Profile
GXHPC 1: GWOXI Stem Cell Applied Technology
GXHPC1 therapy, which uses adipose-derived mesenchymal stem cells (AD-MSCs), has been developed for the treatment of liver cirrhosis. Animal studies have shown that GXHPC1 transplantation can reduce liver fibrosis and promote the recovery of liver function. The therapy is currently undergoing Phase II clinical trials for liver cirrhosis treatment.

LPCN 1148: Lipocine
LPCN 1148 is an oral prodrug of bioidentical testosterone being developed to manage symptoms associated with cirrhosis. The drug is currently in Phase II of clinical trial evaluation for cirrhosis treatment.

Belapectin: Galectin Therapeutics
Belapectin (GR-MD-02) is a proprietary polysaccharide polymer made up of galactoarabino-rhamnogalacturonan, including galacturonic acid, galactose, arabinose, rhamnose, and other sugars. Structural studies show that belapectin binds to galectin-1 and galectin-3, with a higher affinity for galectin-3. Belapectin targets extracellular galectins and is currently in Phase II/III of clinical trials for cirrhosis treatment.

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

Cirrhosis 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
• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

By Molecule Type
• Oligonucleotide
• Peptide
• Small molecule

Scope of the Cirrhosis Pipeline Report
• Coverage: Global
• Key Cirrhosis Companies: Nacuity Pharmaceuticals, CGeneTech, Plex Pharmaceuticals, and others.
• Key Cirrhosis Pipeline Therapies: NPI 002, CGT 1507, Research programme: ocular therapeutics, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Cirrhosis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Cirrhosis Pipeline Therapeutics
6. Cirrhosis Pipeline: Late-Stage Products (Phase III)
7. Cirrhosis Pipeline: Mid-Stage Products (Phase II)
8. Cirrhosis 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

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
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About DelveInsight
DelveInsight is a leading market research and business consulting firm specializing in the life sciences industry. We provide pharmaceutical companies with tailored, end-to-end solutions to optimize their strategies and enhance business outcomes. With our subscription-based platform, PharmDelve, you can access a comprehensive range of healthcare and pharma market research reports, ensuring informed decision-making and sustained growth.

This release was published on openPR.