Non-Alcoholic Steatohepatitis (NASH) Pipeline Insight 2025: REZDIFFRA EU Approval and Emerging Therapies Target Fibrosis and Metabolic Dysregulation | DelveInsight

On 19th August 2025, REZDIFFRA became the first and only therapy approved for Non-Alcoholic Steatohepatitis (NASH) in the EU, following a positive recommendation from the European Medicines Agency (EMA)'s CHMP in June 2025. This milestone marks a historic advancement for a progressive liver disease that has long lacked disease-modifying treatments.

DelveInsight's "Non-Alcoholic Steatohepatitis - Pipeline Insight, 2025" provides a comprehensive analysis of the evolving therapeutic landscape for NASH, a condition characterized by hepatic steatosis, inflammation, and fibrosis, often associated with obesity, type 2 diabetes, and metabolic syndrome. Patients with advanced fibrosis face a high risk of cirrhosis, liver failure, and cardiovascular complications, creating a critical unmet need.

The 2025 pipeline highlights a surge of mechanism-based therapies targeting key drivers of NASH progression, including fibrosis, lipid metabolism, inflammation, and insulin resistance. REZDIFFRA leads the field as a first-in-class agent addressing fibrotic progression, while other promising therapies such as tropifexor (FXR agonist), semaglutide (GLP-1 receptor agonist), and resmetirom (thyroid hormone receptor-β agonist) advance through late-stage trials, demonstrating improvements in liver histology, fibrosis regression, and metabolic parameters. Combination strategies pairing anti-fibrotic and metabolic modulators are gaining attention for enhanced efficacy across diverse patient populations.

Emerging gene therapies, cell-based approaches, and novel anti-inflammatory biologics are also entering early-phase studies, aiming to halt or reverse hepatic damage. Clinical trials increasingly incorporate non-invasive biomarkers, MRI-PDFF, liver stiffness measurements, and patient-reported outcomes to better capture disease-modifying effects.

From a regulatory and market perspective, accelerated pathways, orphan drug designations for advanced fibrosis, and real-world data integration are shaping development timelines. The pipeline underscores a shift toward personalized, multi-targeted approaches, with the potential to transform NASH management from symptomatic care to true disease modification.

With REZDIFFRA's EU approval and a diverse pipeline of emerging therapies, NASH treatment is poised to improve liver health, slow disease progression, and enhance long-term outcomes for patients across the disease spectrum.

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

Key Takeaways from the Non-Alcoholic Steatohepatitis Pipeline Report
• DelveInsight's Non-Alcoholic Steatohepatitis pipeline analysis depicts a strong space with 70+ active players working to develop 75+ pipeline drugs for Non-Alcoholic Steatohepatitis treatment.
• The leading Non-Alcoholic Steatohepatitis companies include Guangdong Raynovent Biotech, Dr. Falk Pharma GmbH, Enyo Pharma, Viking Therapeutics, Eli Lilly and Company, Sagimet Biosciences, Terns, Sinew Pharma, Madrigal Pharmaceuticals, Hepion Pharmaceuticals, Poxel SA, Pfizer, CytoDyn, Altimmune, Oramed Ltd, PharmaKing, Can-Fite Biopharma, Cirius Therapeutics, and others are evaluating their lead assets to improve the Non-Alcoholic Steatohepatitis treatment landscape.
• Key Non-Alcoholic Steatohepatitis pipeline therapies in various stages of development include ZSP1601, ZED1227, EPY 651, VK2809, LY3849891, TVB-2640, TERN-501, SNP-630, Resmetirom, Rencofilstat, PXL065, PF-06865571, leronlimab, Pemvidutide, ORMD-0801, Oltipraz, Namodenoson, MSDC-0602K, and others.
• In August 2025, REZDIFFRA becomes the first and only therapy approved for this severe liver condition in the EU, following a positive recommendation from the European Medicines Agency (EMA)'s CHMP in June 2025. Now, REZDIFFRA is the first and only approved treatment for MASH in the EU.
• In August 2025, the FDA granted accelerated approval to WEGOVY® (semaglutide 2.4 mg) for treating noncirrhotic MASH with moderate to advanced liver fibrosis (F2-F3). Approval was based on the ESSENCE trial, where Wegovy® improved fibrosis and resolved steatohepatitis without worsening disease.
• In August 2025, Sonic Incytes Medical Corp announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for Velacur ONETM, the company's next-generation point-of-care ultrasound elastography device. Building on its predecessor VelacurTM, the new system offers an enhanced interface, improved portability, and expanded functionality to support wider adoption. Velacur ONETM measures attenuation, VDFF (Velacur Determined-Fat Fraction), and liver stiffness using 3D S-WAVE technology, aiding in the management of chronic liver diseases including MASH and MASLD.
• In July 2025, Madrigal Pharmaceuticals announced an exclusive global license agreement with CSPC Pharmaceutical for SYH2086, a preclinical oral GLP-1 receptor agonist and orforglipron derivative. Madrigal plans to start clinical trials in early 2026. This agreement supports their strategy to develop innovative combination treatments for MASH (metabolic dysfunction-associated steatohepatitis), combining SYH2086 with their therapy RezdiffraTM (resmetirom) for a potential best-in-class, once-daily MASH treatment.

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

Non-Alcoholic Steatohepatitis Overview
NASH is a progressive liver disease characterized by fat buildup, inflammation, and liver cell damage in people who drink little or no alcohol. It's part of a broader condition called metabolic dysfunction-associated steatohepatitis (MASH) and is linked to obesity, diabetes, and metabolic syndrome. If left untreated, NASH can lead to fibrosis, cirrhosis, or liver cancer. Early stages may have no symptoms, making diagnosis and management, through lifestyle changes and emerging therapies, critical to slowing disease progression.

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

Non-Alcoholic Steatohepatitis Treatment Analysis: Drug Profile
Survodutide: Boehringer Ingelheim
Survodutide is a dual GLP-1/glucagon receptor agonist designed to target metabolic dysfunction and liver diseases like NASH. It works by improving glucose regulation, reducing liver fat, and controlling inflammation-key factors in disease progression. Currently in Phase III trials, Survodutide offers a novel approach to managing NASH and preventing liver fibrosis and cirrhosis.

AZD2693: AstraZeneca
AZD2693 is a liver-targeted antisense oligonucleotide that reduces PNPLA3 mRNA expression, particularly in patients with the high-risk 148M genetic variant. It has shown potential in lowering liver fat, inflammation, and fibrosis in preclinical studies. The drug is currently in Phase II development for NASH.

ALN-HSD: Regeneron Pharmaceuticals (with Alnylam)
ALN-HSD is an RNAi therapeutic that targets HSD17B13, a gene linked to reduced risk of liver disease when its function is lost. By mimicking this protective effect, ALN-HSD aims to slow NASH progression. It is administered subcutaneously and is in Phase II clinical development.

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

Non-Alcoholic Steatohepatitis 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
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the Non-Alcoholic Steatohepatitis Pipeline Report
• Coverage: Global
• Key Non-Alcoholic Steatohepatitis Companies: Guangdong Raynovent Biotech, Dr. Falk Pharma GmbH, Enyo Pharma, Viking Therapeutics, Eli Lilly and Company, Sagimet Biosciences, Terns, Sinew Pharma, Madrigal Pharmaceuticals, Hepion Pharmaceuticals, Poxel SA, Pfizer, CytoDyn, Altimmune, Oramed Ltd, PharmaKing, Can-Fite Biopharma, Cirius Therapeutics, and others.
• Key Non-Alcoholic Steatohepatitis Pipeline Therapies: ZSP1601, ZED1227, EPY 651, VK2809, LY3849891, TVB-2640, TERN-501, SNP-630, Resmetirom, Rencofilstat, PXL065, PF-06865571, leronlimab, Pemvidutide, ORMD-0801, Oltipraz, Namodenoson, MSDC-0602K, and others.

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

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