Sumida Yoshio, Okanoue Takeshi, Nakajima Atsushi
Division of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University, Nagakute, Japan.
Saiseikai Suita Hospital, Suita, Japan.
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.
非酒精性脂肪性肝炎（NASH）是一种更严重的非酒精性脂肪性肝病形式，至少部分会导致肝硬化、肝细胞癌和肝衰竭。目前，肝移植是NASH肝硬化的唯一选择。预计到2020年，NASH将超过丙型肝炎，成为美国肝移植的主要原因。目前仍没有获批用于治疗NASH的药物。尽管在不同开发阶段大约有196种NASH治疗的研究药物，但我们在此主要综述处于NASH研发后期的3期候选药物。美国、法国、德国、意大利、西班牙、英国和日本这七个主要市场的NASH市场规模预计将从2016年的6.18亿美元增长到2026年的约253亿美元。然而，开发有效抗NASH药物的竞赛已进入最后阶段，有五种候选药物（奥贝胆酸、elafibranor、selonsertib、cenicriviroc和resmetirom）处于试验的3期阶段，这对患者来说是个好消息。假设一切按计划顺利进行，最早一种NASH药物可能在2021年上市。
