FDA approval of REZDIFFRA (resmetirom) for NASH/MASH treatment

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This video describes the approval of REZDIFFRA, which contains resmetirom as its active pharmaceutical ingredient. REZDIFFRA is approved for treatment of liver fibrosis due to NASH (non-alcoholic steatohepatits) or MASH (metabolic dysfunction-associated steatohepatits). REZDIFFRA was approved by the U.S. FDA on March 14, 2024. The sponsor of the NDA was Madrigal Pharmaceuticals. Resmetirom's mechanism of action is as a thyroid receptor-beta agonist with selectivity for the beta receptor over the alpha form. Efficacy, ADME/PK, and key safety risks of REZDIFFRA are discussed.
This video was created for academic purposes. The creator of the video has no financial stake in the drug sponsors or relationship with the FDA.

[@usernamehere94]

Thank you very much for making this video. You're one of the only channels that (I'm aware of) covers medicinal chemistry in an accent that I can understand easily. Please keep up the great work as long as you are able.

[@ChemHelpASAP]

I'm working on it. Sometimes it's hard to keep up with the FDA.

[@joshyu1124]

resmetirom also has liver-loading property, about 8:1 liver to plasma ratio in mice. Great video!

[@ChemHelpASAP]

In this case, the idea that an oral drug must first traverse the liver, which happens to be its site of action, can be leveraged to some benefit.

[@rahulmalik4887]

Is it use in alcohal hepatitis

[@mihirpal8561]

Is resmetirom for NAFLD or for NASH or for both?

[@ChemHelpASAP]

Resmetirom is approved for NASH, not NAFLD. It might help on NAFLD, but the drug's efficacy was measured on steatohepatitis.