Madrigal Pharmaceuticals' Resmetirom Receives Breakthrough Therapy and Fast Track Designations from FDA

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Madrigal Pharmaceuticals, Inc., a Pennsylvania-based biopharmaceutical company focused on developing therapies for endocrinology and metabolic diseases, has announced that their small molecule drug Resmetirom has been granted Breakthrough Therapy Designation and Fast Track Designation from the US Food and Drug Administration (FDA) for the treatment of liver cirrhosis and non-alcoholic steatohepatitis (NASH).

Resmetirom is a THR-β agonist that targets the thyroid hormone receptor beta. It is currently in Phase 3 clinical trials and has shown promising results in treating liver diseases, including non-alcoholic fatty liver disease (NAFLD), NASH, and hyperlipoproteinaemia type IIa. Inactive indications for Resmetirom include congenital disorders and heterozygous familial hypercholesterolemia.

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来源: SYNAPSE

Madrigal Pharmaceuticals, Inc. was founded in 2016 and focuses on developing small molecule drugs for therapeutic areas such as endocrinology and metabolic disease, neoplasms, and immune system disorders. They utilize technologies such as small molecule drugs and frequently develop targets like THR-β, HSP90, and CRAC.

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来源: SYNAPSE

The Breakthrough Therapy Designation from the FDA is granted to drugs that show significant improvements in treating serious or life-threatening conditions, while the Fast Track Designation is designed to expedite the development and review process of drugs that address unmet medical needs. These designations are a significant milestone for Madrigal Pharmaceuticals and their ongoing efforts to bring innovative therapies to patients suffering from liver diseases.