Alcoholic Hepatitis Pipeline Insight 2025: Advancing Targeted Immunomodulators and Regenerative Therapies for a High-Mortality Liver Condition | DelveInsight

DelveInsight's "Alcoholic Hepatitis - Pipeline Insight, 2025" presents a comprehensive analysis of the evolving therapeutic landscape for Alcoholic Hepatitis (AH), a severe and often life-threatening inflammatory liver condition triggered by chronic excessive alcohol intake. Characterized by jaundice, liver failure, and systemic inflammation, AH carries a high short-term mortality, particularly in patients with severe forms, and remains an area of urgent unmet clinical need due to the absence of FDA-approved therapies.

Traditionally, treatment has relied on corticosteroids, such as prednisolone, to dampen inflammation; however, their modest survival benefit, contraindications in certain infections, and lack of long-term efficacy have driven the search for more effective and targeted options. The pipeline in 2025 features a dynamic mix of candidates aiming to modulate immune dysregulation, promote hepatic regeneration, and prevent multi-organ complications. Several late-stage and early-phase trials are evaluating novel anti-inflammatory agents, gut-liver axis modulators, and cell-based therapies.

Notable programs include DURECT Corporation's investigational drug larsucosterol (DUR-928), a first-in-class endogenous sulfated oxysterol modulator targeting multiple pathways, including oxidative stress, lipid metabolism, and inflammation. The agent has demonstrated promising survival signals in Phase II trials and is currently being studied in the AHFIRM Phase III trial. Other candidates under exploration involve IL-1β inhibitors, TNF-alpha modulators, and microbiome-focused therapies that aim to restore intestinal barrier function and reduce endotoxemia.

Regulatory authorities, including the FDA and EMA have acknowledged the urgent need for innovation in this field, granting Fast Track and orphan drug designations to several assets, thereby facilitating accelerated clinical development. Biomarker-driven patient stratification and evolving consensus on clinical trial endpoints are also refining study designs in this complex, heterogeneous condition.

With a growing pipeline, deeper mechanistic understanding, and increasing investment from biotech and academic consortia, the therapeutic outlook for Alcoholic Hepatitis is becoming more hopeful. As 2025 unfolds, the progress being made offers cautious optimism for addressing the historically poor outcomes associated with this challenging liver disease.

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

Key Takeaways from the Alcoholic Hepatitis Pipeline Report
• DelveInsight's Alcoholic Hepatitis pipeline analysis depicts a strong space with 11+ active players working to develop 13+ pipeline drugs for Alcoholic Hepatitis treatment.
• The leading Alcoholic Hepatitis companies include Intercept Pharmaceuticals, Seal Rock Therapeutics, Surrozen, Novartis Pharmaceuticals, NEXEL, Aldeyra Therapeutics, and others are evaluating their lead assets to improve the Alcoholic Hepatitis treatment landscape.
• Key Alcoholic Hepatitis pipeline therapies in various stages of development include INT-787, SRT-015, SZN-043, Canakinumab, NP-011, ADX-629, and others.
• In April 2025, although focusing on hepatocellular carcinoma, this FDA action reflects broader advancements in liver disease diagnostics. The "EvoLiver" blood test received Breakthrough Device Designation, underlining regulatory momentum for liver-related innovations
• In September 2024, following a Type B meeting under Breakthrough Therapy status, the FDA endorsed a registrational Phase III trial for larsucosterol with a 90-day survival endpoint. The study aims to enroll ~200 U.S. patients and could support a rolling New Drug Application (NDA) upon positive results

Request a sample and discover the recent breakthroughs happening in the Alcoholic Hepatitis pipeline landscape at https://www.delveinsight.com/report-store/alcoholic-hepatitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Alcoholic Hepatitis Overview
Alcoholic hepatitis is an inflammatory liver condition caused by excessive and prolonged alcohol consumption. It ranges from mild to severe and can lead to liver damage, including cirrhosis and liver failure. Symptoms often include jaundice, fatigue, abdominal pain, and fever.

The disease results from alcohol-induced liver injury, triggering inflammation and liver cell death. Diagnosis is based on clinical history, lab tests, and sometimes liver biopsy. Treatment focuses on abstaining from alcohol, nutritional support, and managing complications. Severe cases may require corticosteroids or other therapies to reduce inflammation.

Find out more about Alcoholic Hepatitis medication at https://www.delveinsight.com/report-store/alcoholic-hepatitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Alcoholic Hepatitis Treatment Analysis: Drug Profile
INT-787: Intercept Pharmaceuticals
INT-787 is Intercept's next-generation farnesoid X receptor (FXR) agonist, designed to target diseases affecting both the gut and liver, including severe alcohol-associated hepatitis (sAH). It is currently in Phase II clinical trials for treating Alcoholic Hepatitis.

SRT-015: Seal Rock Therapeutics
SRT-015 is a second-generation ASK1 inhibitor with an improved safety profile, developed specifically for liver diseases. It works through a trimodal mechanism-antifibrotic, anti-inflammatory, and anti-apoptotic effects-demonstrated in lab and animal studies. SRT-015 is currently in Phase I clinical trials for Alcoholic Hepatitis.

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

Alcoholic Hepatitis 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 Alcoholic Hepatitis Pipeline Report
• Coverage: Global
• Key Alcoholic Hepatitis Companies: Intercept Pharmaceuticals, Seal Rock Therapeutics, Surrozen, Novartis Pharmaceuticals, NEXEL, Aldeyra Therapeutics, and others.
• Key Alcoholic Hepatitis Pipeline Therapies: INT-787, SRT-015, SZN-043, Canakinumab, NP-011, ADX-629, and others.

To dive deep into rich insights for drugs used for Alcoholic Hepatitis treatment, visit: https://www.delveinsight.com/report-store/alcoholic-hepatitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Alcoholic Hepatitis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Alcoholic Hepatitis Pipeline Therapeutics
6. Alcoholic Hepatitis Pipeline: Late-Stage Products (Phase III)
7. Alcoholic Hepatitis Pipeline: Mid-Stage Products (Phase II)
8. Alcoholic Hepatitis 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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This release was published on openPR.