drug · small molecule

REZDIFFRA

updated 2mo ago

by $MDGL MADRIGAL PHARMACEUTICALS, INC.🔗 ChEMBL

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Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for non-alcoholic fatty liver disease and cirrhosis of liver and 5 investigational indications.

targets

Thyroid hormone receptor beta

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brand

REZDIFFRA

trade names

Rezdiffra

generic

RESMETIROM

MOA

Thyroid hormone receptor beta-1 agonist

indication

1 INDICATIONS AND USAGE REZDIFFRA is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic 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 NASH and fibrosis [see Clinical Studies (14) ] . 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 [see Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ] . REZDIFFRA is a thyroid hormone receptor-beta (THR-beta) agonist indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic 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 NASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1) Limitations of Use Avoid use of REZDIFFRA in patients with decompensated cirrhosis. (1)

REZDIFFRA

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Trials studying REZDIFFRA