Journal
JOURNAL OF DIGESTIVE DISEASES
Volume 22, Issue 2, Pages 72-82Publisher
WILEY
DOI: 10.1111/1751-2980.12967
Keywords
clinical trial; efficacy; non‐ alcoholic steatohepatitis; safety
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NASH is an inflammatory type of nonalcoholic fatty liver disease, currently treated primarily by lifestyle intervention. There are currently no FDA-approved drugs for treating NASH, but several drugs are in various stages of clinical trials and have shown positive effects on hepatic fibrosis.
Nonalcoholic steatohepatitis (NASH) is an inflammatory type of nonalcoholic fatty liver disease and is associated with the development and progression of cirrhosis. Lifestyle intervention is still the predominant treatment for NASH. So far, no drugs have been approved to treat NASH by the U.S. Food and Drug Administration (FDA). Vitamin E has been recommended for patients with NASH without type 2 diabetes mellitus (T2DM), whereas a combination of pioglitazone and vitamin E is recommended for patients with both NASH and T2DM. Encouragingly, drugs are currently being developed for different NASH mechanisms. Some of the drugs are at phase III clinical trials, including obeticholic acid (OCA), Elafibranor, Cenicriviroc, Selonsertib, Resmetirom, Emricasan and Aramchol. Due to its positive interim effect in attenuating the degree of hepatic fibrosis OCA was filing in FDA. However, it has been rejected by the U.S FDA and has been advised to conduct long-term studies. Therefore, in this article, we reviewed the efficacy and safety of drugs currently under clinical trials for NASH.
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