Anpheros Search · Treatment

Resmetirom

Also known as: Rezdiffra

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In short

Resmetirom is a thyroid hormone receptor-beta agonist indicated in the United States and the European Union in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis, formerly known as nonalcoholic steatohepatitis, with moderate to advanced liver fibrosis consistent with stages F2 to F3 fibrosis. In the United States, this indication is approved under accelerated approval based on improvement of metabolic dysfunction-associated steatohepatitis and fibrosis, and continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. The use of this medication should be avoided in patients with decompensated cirrhosis. Resmetirom is listed by the cited source as having an approved use for fibrosis and cirrhosis of the liver.

From: Source: European Medicines Agency (EMA), Rezdiffra — EPAR, 27/05/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
2677894 resmetirom
EMA
EMEA/H/C/006220

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Rezdiffra

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).

Source: European Medicines Agency (EMA), Rezdiffra — EPAR, 27/05/2026. © European Medicines Agency.

Document date: 27/05/2026 · Official document →

FDA (USA) REZDIFFRA

1 INDICATIONS AND USAGE REZDIFFRA ® is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication is approved under accelerated approval based on improvement of MASH and fibrosis [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitations of Use Avoid use of REZDIFFRA in patients with decompensated cirrhosis [see Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ] . REZDIFFRA ® is a thyroid hormone receptor-beta (THR-beta) agonist indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1) Limitations of Use Avoid use of REZDIFFRA in patients with decompensated cirrhosis. (1)

Data provided by the U.S. Food and Drug Administration.

Document date: 20260729 · Official document →

Related terms in the cited sources

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External resources

Questions

What is Resmetirom approved for in the European Union?

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). (Source: European Medicines Agency (EMA), Rezdiffra — EPAR, 27/05/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Rezdiffra — EPAR, 27/05/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →