Generic Name: darolutamide

Pronunciation: N/A

Abbreviation: N/A

Other Market Name: N/A

Drug Class: Hormone Therapy Medications

Company: Bayer

Approval Status: Approved

Generic Version Available: No

Experimental Code: N/A

Drug Indication

Nubeqa is an androgen receptor inhibitor approved for the treatment of nonmetastatic prostate cancer that progresses despite low testosterone levels (known as castration-resistant).

General Info

Testosterone and other male hormones (androgens) stimulate prostate cancer growth. To do so, they must bind to androgen receptors in prostate cells. Nubeqa blocks signals from androgen receptors, preventing them from triggering cancer proliferation. It should be combined with drugs such as GnRH agonists that reduce testosterone production, known as androgen deprivation therapy (ADT).

In the Phase III ARAMIS trial, Nubeqa plus androgen deprivation therapy improved metastasis-free survival compared to ADT alone, extending the amount of time patients were alive without their cancer spreading from 18 to 40 months. Nubeqa was approved in July 2019.


Dosing Info:

Nubeqa is taken as pill. The usual dose is two tablets taken together twice daily.

Side Effects

Common side effects include fatigue, pain in the extremities and skin rash. Nubeqa may cause fetal harm, and men with partners who are or wish to become pregnant should use effective contraception.

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Patient Assistance Program Info:

Last Reviewed: July 30, 2019