NASH Drug Development: Seeing the Light at the End of the Tunnel?

Nonalcoholic steatohepatitis (NASH) is a chronic liver disease affecting a large population worldwide. No clinically approved drugs are available. In this minireview, we discuss the heterogeneous nature of NASH and lack of consensus in outcome measures among clinical trials. We summarize NASH therapeutic targets and candidate drugs. We compare the efficacy of 33 published clinical trials that evaluated noninvasive biomarkers and liver biopsy. Currently, phase II trial results of fibroblast growth factor 21 (FGF21) and phase III trial results of resmetirom and pioglitazone are encouraging.

Automated summary

Nonalcoholic steatohepatitis (NASH) is a prevalent chronic liver disease with no approved drugs available. This minireview highlights the heterogeneous nature of NASH and the lack of consensus in outcome measures among clinical trials. We summarize potential therapeutic targets and candidate drugs for NASH treatment. Efficacy comparison of 33 published clinical trials evaluating noninvasive biomarkers and liver biopsy shows encouraging results for fibroblast growth factor 21 (FGF21), resmetirom, and pioglitazone in phase II and III trials, respectively.