Nonalcoholic steatohepatitis (NASH) is emerging as a major public health issue for the 21st century and is associated with significant liver-related morbidity and mortality. At present, there are no approved drug therapies for NASH. Consequently, NASH has become the focus of significant public and private research and development. In this review, we highlight the research and development (R&D) challenges and opportunities in this emerging therapeutic area. In particular, we consider the impact of the development of new biomarker strategies on clinical trial execution and design, and the positioning of single and combination therapies in future approaches to the treatment of NASH.

非酒精性脂肪性肝炎（NASH）成为21世纪的主要公共卫生问题，并且与肝脏相关的高发病率和死亡率相关。目前，尚无批准用于NASH的药物疗法。因此，NASH已成为重要的公共和私人研究与开发的重点。在本文中，我们重点介绍了这一新兴治疗领域的研发（R＆D）挑战和机遇。特别是，我们考虑了新的生物标志物策略的开发对临床试验执行和设计的影响，以及单一疗法和联合疗法在NASH未来治疗方法中的定位。