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.

Liver
Drug sponsors are pursuing a variety of treatment pathways in NASH

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.

While those drugs, anticipated to be perhaps the first and second approved therapies for NASH, have been sidelined, a group of then-mid-stage candidates from several dozen drug classes

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