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Darolutamide (BAY 1841788)
Darolutamide is a non-steroidal androgen receptor inhibitor that blocks androgen signaling in prostate cancer cells.
Darolutamide is a non-steroidal androgen receptor inhibitor that blocks androgen signaling in prostate cancer cells. Used for Non-metastatic castration-resistant prostate cancer (nmCRPC), Metastatic hormone-sensitive prostate cancer (mHSPC).
At a glance
| Generic name | Darolutamide (BAY 1841788) |
|---|---|
| Also known as | NUBEQA, Nubeqa |
| Sponsor | Canadian Cancer Trials Group |
| Drug class | Non-steroidal androgen receptor antagonist |
| Target | Androgen receptor (AR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Darolutamide binds to the androgen receptor with high affinity and specificity, preventing androgen-driven transcription and proliferation of prostate cancer cells. Unlike some older androgen receptor antagonists, it has improved blood-brain barrier penetration and a longer half-life, allowing for more effective suppression of castration-resistant prostate cancer progression.
Approved indications
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic hormone-sensitive prostate cancer (mHSPC)
Common side effects
- Fatigue
- Hot flashes
- Hypertension
- Rash
- Diarrhea
Key clinical trials
- Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response (PHASE3)
- 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)
- A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) (PHASE4)
- A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Darolutamide (BAY 1841788) CI brief — competitive landscape report
- Darolutamide (BAY 1841788) updates RSS · CI watch RSS
- Canadian Cancer Trials Group portfolio CI