The future R&D landscape in non-alcoholic steatohepatitis (NASH)

•There is an unmet need for new therapies to treat NASH.•New therapies will have different modes of action, aligned to the stage of disease.•They must have additive benefit, in combination with emerging standards of care.•New biomarkers and pre-clinical models will facilitate drug research and development.•The new therapeutic approaches could permit individualized patient treatment. 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.