Review and Reflection on the Development of New Drugs for Non-Alcoholic Steatohepatitis
Non-alcoholic fatty liver disease(NAFLD)has become the most prevalent chronic liver disease in China.Among the various phenotypes of NAFLD,non-alcoholic steatohepatitis(NASH)is highly likely to develop into end-stage liver diseases,including cirrhosis and liver cancer,leading to increased mortality.This is also the main cause of liver transplantation in developed countries or region in Europe and America.At present,the treatment of NASH remains in the form of combination therapy,and there are serious unmet clinical needs for targeted new drugs.Apart from the approval of the new drug Resmetirom in the United States,no other NASH new drugs are on the market domestically or internationally.The medicinal properties and evaluation criteria of NASH new drugs have always been of significant concern.The lack of support for non-clinical pharmacodynamics research and the impact of clinical trials not meeting endpoint evaluation indicators on the druggability of new drugs are reflected in the development status of NASH new drugs.This also suggests that whether non clinical pharmacodynamics research results support the use of NASH clinical trials and whether clinical trials can achieve evaluation endpoints are key factors in promoting the development process of NASH new drugs.
non-alcoholic fatty liver diseasenon-alcoholic steatohepatitisefficacydruggabilityreview and reflection