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| Trade names | Rezdiffra |
| Other names | MGL-3196 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a624021 |
| License data | |
| Routes of administration | By mouth |
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| Chemical and physical data | |
| Formula | C17H12Cl2N6O4 |
| Molar mass | 435.22 g·mol−1 |
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Resmetirom, sold under the brand nameRezdiffra, is a new medication used to treat a form offatty liver disease. Specifically it is used in the treatment of noncirrhoticmetabolic dysfunction associated steatohepatitis (MASH) (formerly known as nonalcoholic steatohepatitis NASH).[1] It is structurally similar to thethyroid hormonetriiodothyronine and acts as anagonist of thethyroid hormone receptor beta (NR1A2).[1]
The most common side effects include diarrhea and nausea.[4]
Resmetirom was approved for medical use in the United States in March 2024,[4] and in the European Union in August 2025.[3] The USFood and Drug Administration considers it to be afirst-in-class medication.[5]
Resmetirom isindicated, in conjunction with diet and exercise, for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis with moderate to advancedliver fibrosis (consistent with stages F2 to F3 fibrosis).[1][4]
In a phase III clinical trial, it was found to be effective for resolving noncirrhotic nonalcoholic steatohepatitis and improving liver fibrosis.[6]
The USFood and Drug Administration (FDA) evaluated the safety and efficacy of resmetirom based on an analysis of a surrogate endpoint at month twelve in a 54-month, randomized, double-blind placebo-controlled trial.[4] The surrogate endpoint measured the extent of liver inflammation and scarring.[4] The FDA requires the sponsor to conduct a postapproval study to verify and describe the clinical benefit of resmetirom, which will be done through completing the same 54-month study.[4] In the trial, 888 participants were randomly assigned to receive one of the following: placebo (294 participants); 80 milligrams of resmetirom (298 participants); or 100 milligrams of resmetirom (296 participants); once daily, in addition to standard care for noncirrhotic nonalcoholic steatohepatitis, which includes counseling for healthy diet and exercise.[4]
The FDA granted the application for resmetirom accelerated approval, along withbreakthrough therapy,fast track, andpriority review designations.[4] The FDA granted the approval of Rezdiffra to Madrigal Pharmaceuticals.[4]
Resmetirom was approved for medical use in the United States in March 2024.[7]
In June 2025, theCommittee for Medicinal Products for Human Use of theEuropean Medicines Agency adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Rezdiffra, intended for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH).[2] The applicant for this medicinal product is Madrigal Pharmaceuticals EU Limited.[2][8] Resmetirom was authorized for medical use in the European Union in August 2025.[2][3]
A systematic review and meta-analysis of resmetirom, published in 2024, found that it is well tolerated and that it improves hepatic fat content, liver enzymes, and fibrosis biomarkers in people with non-alcoholic steatohepatitis (NASH).[9]
This article incorporates text from this source, which is in thepublic domain.
