Resmetirom

In the field of metabolic disease treatment, resmetirom provides a brand-new clinical pathway for the management of residual cardiovascular risk in patients with hyperlipidemia and mixed dyslipidemia. As a novel selective β3 adrenoceptor agonist, it can activate β3 receptors in adipose tissue, liver and muscle to promote lipolysis and energy expenditure, while reducing triglyceride and low-density lipoprotein cholesterol levels, increasing high-density lipoprotein cholesterol, and also having the effect of improving insulin sensitivity. It is indicated for adult patients with primary hyperlipidemia and mixed dyslipidemia, and is an important combination or alternative treatment option especially for people who are intolerant to statins or have poor达标 response.

The global resmetirom market is currently in the early stage of rapid growth. In 2023, its global sales have exceeded USD 470 million, with a compound annual growth rate of over 82%. The current market is dominated by the original manufacturer. As a high-demand market where the prevalence of hyperlipidemia exceeds 40%, China has not yet approved any local generic preparations, and only a small number of enterprises have initiated bioequivalence trials. In the future, with the improvement of clinical awareness and the entry of generic pharmaceutical enterprises, the domestic market size is expected to exceed RMB 1.5 billion by 2030.

The original developer of resmetirom is Astellas Pharma of Japan, with the original brand name "Epadel". Its core compound patent in Japan expired in 2022, and the compound patent in China will expire in 2027. The main dosage form approved for the original drug is oral tablet, with specifications of 0.25 mg and 0.5 mg, which has been included in the Pharmaceutical Product List of the Ministry of Health, Labour and Welfare of Japan and the FDA Orange Book Reference Listed Drug Catalog. Up to now, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China has not yet published the registration number of approved domestic resmetirom active pharmaceutical ingredients, and the original preparation has not been approved for marketing in mainland China. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of resmetirom impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable reference material support for generic drug research and development, quality research and consistency evaluation work.