Author information
1
Innovative Medicines Unit, Grünenthal Innovation, Zieglerstrasse 6, 52078 Aachen, Germany; TherapeutAix, Juttastrasse 18, 52066 Aachen, Germany. Electronic address: Darcey.black@grunenthal.com.
2
Innovative Medicines Unit, Grünenthal Innovation, Zieglerstrasse 6, 52078 Aachen, Germany.
3
Innovative Medicines Unit, Grünenthal Innovation, Zieglerstrasse 6, 52078 Aachen, Germany; TherapeutAix, Juttastrasse 18, 52066 Aachen, Germany.
4
TherapeutAix, Juttastrasse 18, 52066 Aachen, Germany.
Abstract
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, NASHhas 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.