Key Factors Affecting on the Drug Development for NAFLD/NASH

• 1、School of Biology and Biological Engineering,South China University of Technology
• 2、Guangzhou Boji Medical Technology Co.,Ltd.

Abstract：Nonalcoholic fatty liver disease (NAFLD) / nonalcoholic steatohepatitis (NASH) is one of the most common chronic liver diseases. The incidence rate is around 24% worldwide, and has become a global health problem. The pathogenesis of NAFLD/NASH is complex, which involving complex interactions among multi-factors including lipid deposition, inflammation, oxidative stress, fibrosis, abnormal bile acid metabolism, intestinal flora imbalance and susceptibility gene variation, etc. At present, a variety of new drugs with different targets are in various clinical stages, and a number of crucial phase II anKey Factors Affecting on the Drug Development for NAFLD/NASHd phase III researches have not reached the primary end points, which also poses new challenges to the R&D of innovative drugs in this field. This article reviews the key factors affecting the success of innovative drug development for NAFLD/NASH, including the renewed disease definition, the selection of preclinical animal models, the consideration of clinical trial plans, and discusses how to improve the success rate of innovative drug R&D in NAFLD/NASH.???

Keywords： Pharmacology；NAFLD；MAFLD；animal model；clinical design