Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)

This document provides detailed information and specifications for the content of the tabulated domains and analysis data sets submitted to FDA as part of the sponsor’s application for drugs intended to treat noncirrhotic nonalcoholic steatohepatitis (NASH). Revised nomenclature for NASH was introduced in 2023. The new nomenclature for NASH is metabolic dysfunction-associated steatohepatitis (MASH) with no change in histopathological criteria. FDA considers the term NASH interchangeable with MASH and has maintained the former nomenclature for NASH in this guidance pending universal acceptance of the new nomenclature.

This guidance does not provide recommendations for clinical development of drugs intended for the treatment of NASH, or assessment of potential drug-induced liver injury.