FDA label

What is Rezdiffra used for?

Rezdiffra contains resmetirom. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.

Source: DailyMed SPL label file dated 2026-10-23. Publisher page

The FDA label says: “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).”

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Rezdiffra, tablet, coated

Indications and Usage, quoted from the label by Madrigal Pharmaceuticals, Inc. (NDA217785). Cross-references to other label sections are left out.

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. 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.

Source: DailyMed label, set id e67ea09f-a840-439c-86c8-f98585f978b2, version 4, effective July 29, 2026. NDC 82576-060, one of 3 listings for this product.

Questions

What is Rezdiffra used for?

The FDA label says: “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).”

What drug class is Rezdiffra?

FDA lists resmetirom in the Thyroid Hormone Receptor beta Agonist established pharmacologic class.

Does this page cover off-label uses or dosing?

No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.

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