Healthcare Professionals

About ReMASH

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Indication

ReMASH is indicated for adults with non-cirrhotic MASH and moderate-to-advanced fibrosis (F2-F3).

Not indicated for cirrhosis or decompensated liver disease.

Strengths

60 mg, 80 mg, 100 mg

Mechanism of Action

Resmetirom is a selective THR-β agonist that:

  • Reduces hepatocellular lipotoxicity
  • Enhances mitochondrial activity
  • Improves lipid metabolism (↓ LDL-C, ↓ triglycerides, ↓ ApoB)
  • Reduces liver inflammation and fibrosis progression
Dosing & Administration
  • <100 kg: 80 mg once daily
  • ≥100 kg: 100 mg once daily
  • With moderate CYP2C8 inhibitors (e.g., clopidogrel):
    • <100 kg: 60 mg once daily
    • ≥100 kg: 80 mg once daily
  • With or without food
  • Tablets should not be crushed or split

Clinical Data

MAESTRO-NASH (NEJM, 2024):
  • NASH resolution: 25 - 29% vs 9% with placebo (P<0.001)
  • Fibrosis improvement: 24 - 26% vs 14% with placebo (P<0.001)
  • LDL-C reduction: 13 - 16% vs 0.1% with placebo (P<0.001)
Safety
  • Favourable safety profile; diarrhoea, nausea, abdominal discomfort are the most commonly reported AEs
  • Few discontinuations reported due to AEs

Safety & Monitoring

Common AEs (≥5%)

Diarrhoea, nausea, dizziness, constipation, abdominal pain, and pruritus

Monitoring Recommendations
  • Baseline and periodic LFTs
  • Lipid profile, HbA1c, thyroid function test and fibrosis assessment every 6 - 12 months
  • Watch for gallbladder dysfunction
Contraindications
  • Pregnancy and lactation
  • Pediatric population
  • Concomitant use with strong CYP2C8 inhibitors (e.g., gemfibrozil)
  • Severe renal impairment or in those undergoing dialysis
  • Excess alcohol consumption (>20 g/d in women and 30 g/d in men)
  • Cirrhosis or Decompensated liver disease
  • Patients with symptomatic gallstone-related conditions such as acute cholecystitis

HCP Resources

Diagnostic & pre-treatment checklist

Before starting ReMASH, ensure:

  • ✔   Confirmed non-cirrhotic MASH with fibrosis (F2-F3)
  • ✔   Baseline blood work: AST/ALT, bilirubin, HbA1c, lipid profile, thyroid function test
  • ✔   Imaging: FibroScan® or MRI (if available)
  • ✔   No history of decompensated liver disease, gallstones, or severe hepatic impairment
  • ✔   Current medications reviewed (watch for CYP2C8 interactions, gemfibrozil, clopidogrel, cyclosporine, rifampicin, statins)
Clinical Trial Summaries
  • NASH resolution in 25 - 29% vs 9% placebo
  • Fibrosis improvement in 24 - 26% vs 14% placebo
  • LDL-C reduction by 13 - 16%
  • Safety profile: mostly mild GI events
Other Data Highlights
  • Improves insulin sensitivity and cardiovascular outcomes
  • Enhances health-related quality of life
  • Long-term extension study shows sustained benefits up to 52 weeks
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