molecules of the month

Madrigal THRβ-selective agonist

oral, QD THRβ-selective agonist

Ph. III for NASH

opt. of triiodothyronine

resmetirom (MGL-3196)

Madrigal Pharmaceuticals, West Conshohocken, PA

1 min read

Resmetirom is an oral, liver-targeting, once-daily THRβ-selective agonist, which in December 2022 became the first drug to meet its primary endpoints in Ph. III for NASH, demonstrating both NASH resolution and no worsening of fibrosis by biopsy over placebo in 316 test patients. Madrigal will file an NDA for resmetirom in 2023, allowing it to potentially become the first novel drug approved for NASH in decades. Numerous molecules, pathways, and targets have been explored for NASH with limited success even on surrogate endpoints. The molecule, originally discovered by Roche, mimics the effect of the thyroid hormone from which it is derived, regulating liver lipid metabolism and reducing liver fat. With isoform selectivity over THRɑ, this drug avoids the adverse effects…

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