Last reviewed 2026-04-20 · How we verify

Nubeqa (darolutamide)

Darolutamide inhibits androgen receptor activity, reducing prostate cancer cell growth and tumor size.

Nubeqa (darolutamide) is a small molecule modality developed by Bayer Healthcare Pharmaceuticals Inc, targeting the androgen receptor. It is FDA-approved for the treatment of hormone refractory and metastatic prostate cancer. Nubeqa is a patented medication with no generic manufacturers available. Key safety considerations include potential side effects such as fatigue, nausea, and increased risk of fractures. As a relatively new medication, its long-term safety profile is still being evaluated.

At a glance

Mechanism of action

Darolutamide works by blocking the androgen receptor, which prevents testosterone from binding and activating the receptor. This inhibition stops the receptor from moving into the nucleus and activating genes that promote cancer cell growth, leading to reduced tumor size in prostate cancer models.

Approved indications

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic castration-sensitive prostate cancer (mCSPC)
• Metastatic castration-sensitive prostate cancer (mCSPC) with docetaxel

Common side effects

• Fatigue
• Pain in extremity
• Rash
• Ischemic heart disease
• Heart failure
• AST increased
• Bilirubin increased
• Neutrophil count decreased

Key clinical trials

• Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response (PHASE3)
• SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer (PHASE2)
• A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001) (PHASE1)
• Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study (PHASE3)
• A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer
• A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described
• Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors (PHASE2)
• Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (PHASE2,PHASE3)

Patents

Primary sources

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