Darolutamide is a third-generation, oral nonsteroidal antiandrogen. It works as an androgen receptor (AR) inhibitor, binding with high affinity directly to the receptor's ligand-binding domain. This binding competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. By blocking the effects of androgens like testosterone, darolutamide decreases the proliferation of prostate cancer cells and induces their death.

Darolutamide is indicated for the treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). It is used in combination with androgen deprivation therapy (ADT). Darolutamide is administered as an oral tablet. By effectively lowering the activity of residual testosterone, darolutamide provides a potent therapeutic option for men with advanced prostate cancer.