Darolutamide (NUBEQA™) is a structurally distinct non-steroidal androgen 
receptor antagonist being developed by Orion and Bayer as a treatment for 
prostate cancer. Based on positive results in the phase III ARAMIS trial, 
darolutamide was recently approved in the USA for the treatment of men with 
non-metastatic castration-resistant prostate cancer. This article summarizes the 
milestones in the development of darolutamide leading to this first approval.