Nubeqa (darolutamide) is a prescription medication classified as a nonsteroidal androgen receptor inhibitor developed by Bayer and Orion Corporation. It is indicated for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC): prostate cancer that continues to progress despite androgen deprivation therapy but has not spread to other parts of the body.

• Metastatic hormone-sensitive prostate cancer (mHSPC): prostate cancer that has spread and still responds to hormone therapy.

Nubeqa works by selectively blocking androgen receptor signaling in prostate cancer cells, thereby preventing testosterone and other male hormones from stimulating cancer growth. Its distinct chemical structure results in low penetration across the blood–brain barrier, which may reduce the risk of certain central nervous system side effects compared to other androgen receptor inhibitors.

It is taken orally, usually at a dose of 600 mg (two 300 mg tablets) twice daily, with food, in combination with ongoing androgen deprivation therapy (surgical castration or LHRH analogues).

Common side effects may include fatigue, rash, decreased appetite, pain in extremities, and laboratory abnormalities (such as liver enzyme elevations). Serious adverse effects can occur, so regular monitoring is advised.

Clinical trials such as ARAMIS and ARASENS demonstrated that Nubeqa significantly improved metastasis-free survival and overall survival in prostate cancer patients compared to placebo, making it a valuable treatment option in advanced prostate cancer management.