Darolutamide is a novel, nonsteroidal androgen receptor (AR)-signaling 
inhibitor. It serves as a second-generation antiandrogen and is currently 
indicated for the treatment of patients with nonmetastatic castration-resistant 
prostate cancer (nmCRPC). The product was approved by the United States Food and 
Drug Administration (FDA) in July 2019 and by the Japanese Ministry of Health, 
Labour and Welfare (MHLW) in January 2020 for the treatment of men with nmCRPC, 
and is awaiting approval in the E.U. for the same indication. This review will 
cover the background, preclinical development, safety, pharmacokinetics, 
pharmacodynamics and clinical studies that led to the approval of darolutamide. 
The key clinical data, ongoing trials and future directions for darolutamide are 
also discussed herein.