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