Late-stage development in non-alcoholic steatohepatitis (NASH) stagnated a bit in 2020 after a pair of setbacks – the US Food and Drug Administration complete response letter to Intercept for the NDA of its drug obeticholic acid and the Phase III failure of Genfit’s elafibranor.
Infographic: A Snapshot Of Non-Alcoholic Steatohepatitis R&D
Madrigal may gain the first NASH approval in early 2024; numerous candidates are lining up behind.
After a multi-year lull, NASH R&D has picked up this past year with key data readouts, several programs advancing toward Phase III and Madrigal's resmetirom under FDA review with a March 2024 action. This graphic provides a look at the overall status of NASH drug R&D.

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