Phase 3 drug pipelines in the treatment of non-alcoholic steatohepatitis

Hepatol Res. 2019 Nov;49(11):1256-1262. doi: 10.1111/hepr.13425. Epub 2019 Oct 25.


Non-alcoholic steatohepatitis (NASH), which is a more severe form of non-alcoholic fatty liver disease, can at least partly lead to cirrhosis, hepatocellular carcinoma, and hepatic failure. Liver transplantation is the only option for NASH cirrhosis at this time. By 2020, NASH is projected to overtake hepatitis C as the leading cause of liver transplants in the USA. There are still no approved drugs for treating NASH. Although there are approximately 196 agents of investigational NASH therapies in various stages of development, we here mainly review phase 3 drug candidates in the pipeline for NASH. The NASH space across the seven major markets of the USA, France, Germany, Italy, Spain, the UK, and Japan, is set to rise from $618 million in 2016 to approximately $25.3 billion by 2026. However, the fact that the race to develop an effective drug against NASH has reached the home stretch, with five drug candidates (obeticholic acid, elafibranor, selonsertib, cenicriviroc, and resmetirom) in phase 3 stage of the trial, is welcome news for patients. The very earliest a NASH drug could hit the market is 2021, assuming all goes well as planned.

Keywords: cenicriviroc; elafibranor; obechicholic acid; resmetirom; selonsertib.