MASH Market Momentum: Late-Stage Assets Fuel Competitive Therapeutic Landscape

Metabolic Dysfunction-Associated Steatohepatitis (MASH), formerly known as Nonalcoholic Steatohepatitis (NASH), is becoming an increasingly urgent global public health issue. This progressive liver disease, characterized by fat buildup in the liver unrelated to alcohol consumption, can lead to inflammation (hepatitis), fibrosis, cirrhosis, and eventually liver cancer.

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Akero Therapeutics Completes Enrollment for Double-Blind Phase III SYNCHRONY Real-World Study of Efruxifermin (EFX) in Patients with Non-Invasively Diagnosed MASH or MASLD - January 2025

Competitive Landscape and Market Positioning

Several major pharmaceutical companies and biotech firms are actively pursuing treatments for MASH:

Leading Late-Stage Pipeline Candidates

Several key players are in advanced clinical development:
• Madrigal Pharmaceuticals - Resmetirom (THR-β Agonist)
• Intercept Pharmaceuticals - Ocaliva (Obeticholic Acid, FXR Agonist)
• Akero Therapeutics - Efruxifermin (FGF21 Analog)
• 89bio - Pegozafermin (FGF21 Analog)
• Novo Nordisk - Semaglutide (GLP-1 Agonist)
• Eli Lilly - Tirzepatide (GLP-1/GIP Agonist)
• Pfizer - PF-06865571 (DGAT2 Inhibitor)

In March 2025- The European Medicines Agency approved AIM-NASH, an AI tool developed using machine learning and trained with extensive pathological data, to assess disease severity in clinical trials.

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Several companies are at the forefront of NASH drug development:

✦ Madrigal Pharmaceuticals: Their drug, Rezdiffra, is currently the only approved treatment for MASH in the U.S.

✦ Novo Nordisk: Conducted a late-stage trial of semaglutide, demonstrating significant improvements in liver fibrosis and resolution of steatohepatitis. Regulatory approval is being sought in the U.S. and EU by mid-2025.

✦ Akero Therapeutics: Reported that 39% of patients treated with their drug efruxifermin (EFX) experienced a reversal in cirrhosis symptoms without worsening, compared to 15% in the placebo group.

✦ Viking Therapeutics: Their drug VK2809 showed promising results in Phase IIb trials, with significant improvements in liver fibrosis and a favorable safety profile.

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This release was published on openPR.