Drug Development for Nonalcoholic Fatty Liver Disease: Landscape and Challenges

Thiagarajan, Prarthana; Aithal, Guruprasad P.

Abstract

Nonalcoholic fatty liver disease (NAFLD) is now the leading cause of chronic liver disease in industrialized economies. With no licensed treatment currently available, together with a growing prevalence that parallels global increases in obesity and type 2 diabetes, NAFLD will dominate the landscape of hepatology for the foreseeable future. A multifaceted etiopathogenesis, paucity of reproducible preclinical models that effectively recreate human NAFLD, and lack of robust surrogate trial endpoints have presented major hurdles in drug discovery and development. Smooth collaboration between bench scientists, biotechnology, pharmaceutical industries, and clinicians will be pivotal to target identification, development of effective therapies, biomarker discovery, and ultimately to bring pipeline drugs to market. This review examines the key challenges remaining in NAFLD drug development, outlines early and late phase clinical trials of candidate treatments, and discusses the journey toward biomarker discovery which may facilitate development of novel endpoints in NAFLD clinical trials, enabling meaningful response to be determined noninvasively.

Citation

Thiagarajan, P., & Aithal, G. P. (2019). Drug Development for Nonalcoholic Fatty Liver Disease: Landscape and Challenges. Journal of Clinical and Experimental Hepatology, 9(4), 515-521. https://doi.org/10.1016/j.jceh.2019.03.002

• Journal Article Type: Article
• Acceptance Date: Mar 5, 2019
• Online Publication Date: Apr 4, 2019
• Publication Date: 2019-07
• Deposit Date: Jun 30, 2023
• Journal: Journal of Clinical and Experimental Hepatology
• Print ISSN: 0973-6883
• Electronic ISSN: 2213-3453
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 9
• Issue: 4
• Pages: 515-521
• DOI: https://doi.org/10.1016/j.jceh.2019.03.002
• Public URL: https://nottingham-repository.worktribe.com/output/1871306
• Publisher URL: https://www.jcehepatology.com/article/S0973-6883(19)30063-5/fulltext