Is Resmetirom approved by the US FDA?

Drugs@FDA lists 1 application product line for Resmetirom, including REZDIFFRA (Prescription).

Is Resmetirom authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Resmetirom: Rezdiffra.

Are there safety signals or safety updates for Resmetirom?

US FDA: 1 entry (latest 2026-07-24).

Active substance

Resmetirom

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
REZDIFFRA	60MG; 80MG; 100MG	tablet · oral	MADRIGAL	Prescription	14 Mar 2024

EMA European Union — centrally authorised medicines

Rezdiffra Madrigal Pharmaceuticals EU Limited · Authorised · authorised 18 Aug 2025 · ATC A05

Therapeutic indication (EMA)

Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).

Safety signals and safety-related labeling changes

US FDA 24 Jul 2026 REZDIFFRA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for resmetirom →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.