resmetirom
Rezdiffra · ATC code A05
- Key facts
- Active substance
- resmetirom
- ATC code
- A05
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Rezdiffra 60 mg film-coated tablets / Rezdiffra 80 mg film-coated tablets / Rezdiffra 100 mg film-coated tablets
- Marketing authorisation holder
- Madrigal Pharmaceuticals EU Limited
- Information as of
- 2026-10-27
Key facts
Resmetirom is an oral medicine for adults with noncirrhotic MASH with moderate to advanced liver fibrosis, used with diet and exercise.
What it is used for
- Adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis stages F2 to F3, with diet and exercise
Dosing
- Body weight < 100 kg: 80 mg once daily
- Body weight ≥ 100 kg: 100 mg once daily
- With moderate CYP2C8 inhibitors (e.g. clopidogrel): reduced from 100 mg to 80 mg, or from 80 mg to 60 mg
- Missed dose: no double dose; taken with or without food
- No adjustment in mild hepatic or any renal impairment; not for moderate or severe hepatic impairment
Contraindications
- Hypersensitivity to the active substance or any excipient
Important warnings
- Cholecystitis more often than with placebo; gallbladder studies if cholelithiasis suspected
- Caution with other liver diseases (autoimmune, active viral hepatitis, alcohol-related)
- Periodic liver enzyme monitoring; discontinue if hepatotoxicity suspected
Side effects
- Very common: diarrhoea and nausea, mostly at treatment initiation, mild to moderate
- Frequently reported: pruritus
- Rare: cholecystitis, urticaria; uncommon dizziness
Interactions
- Strong CYP2C8 inhibitors (e.g. gemfibrozil) not recommended; moderate inhibitors need dose reduction
- Statins: rosuvastatin and simvastatin limited to 20 mg, pravastatin and atorvastatin to 40 mg daily
Pregnancy and breastfeeding
- No data; as a precaution, use during pregnancy is preferably avoided
- Breast-feeding: decision weighing breast-feeding against therapy
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- RezdiffraMadrigal Pharmaceuticals EU Limited · EMEA/H/C/006220
Source: European Medicines Agency (EMA), product information
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Rezdiffra – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/rezdiffra-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.