Resmetirom in metabolic dysfunction-associated steatohepatitis: a profile of its use

<p dir="ltr"><b>Declarations</b></p><p dir="ltr"><b>Funding</b> The preparation of this review was not supported by any external funding.</p><p dir="ltr"><b>Authorship and conflict of interest</b> H. A. Blair is a salaried employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.</p><p dir="ltr"><b>Ethics approval, Consent to participate, Consent for publication, Availability of data and material, Code availability</b> Not applicable.</p><p dir="ltr">Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank"><b>here</b></a>.</p><p dir="ltr"><b>Abstract </b>Resmetirom (Rezdiffra^®), a selective thyroid hormone receptor (THR)-β agonist, represents a promising treatment option for patients with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH). It is the first FDA-approved treatment for MASH/NASH, granted under accelerated approval for use in conjunction with diet and exercise in adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). In the pivotal phase 3 MAESTRO-NASH trial, once-daily oral resmetirom was superior to placebo in achieving the histologic primary endpoints of resolution of NASH with no worsening of fibrosis, and fibrosis improvement by ≥ 1 stage with no worsening of disease severity as measured by NAS. Treatment with resmetirom was also associated with statistically significant and clinically meaningful improvements in health-related quality of life (HRQoL). Resmetirom was generally well tolerated. The most common adverse events were gastrointestinal in nature, and most were of mild to moderate severity.</p><p dir="ltr"><b>©</b> Springer Nature Switzerland AG 2025</p>