Also known as: Nubeqa
Darolutamide is an oral nonsteroidal antiandrogen marketed as Nubeqa for prostate cancer treatment. It is used with surgical or medical castration for non-metastatic castration-resistant prostate cancer and has broad prescription-only approvals in major regions. The drug acts as an androgen receptor antagonist.
ORIC selected rinzimetostat 400 mg plus darolutamide for the Himalayas-1 Phase 3 trial in post-abiraterone mCRPC, expected to start in 1H 2026. The company reported early efficacy and safety data and said cash runway extends into 2H 2028.
Bayer achieved its upgraded 2025 financial targets with group sales reaching 45.6 billion euros and projects solid 2026 performance. The company's pharmaceutical business shows rejuvenation with launch medicines becoming growth drivers, while Crop Science progresses in profitability improvement. Bayer continues strategic diversification in oncology and addresses litigation challenges while implementing cost-saving measures.
The FDA has accepted Celcuity's New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, granting Priority Review with a PDUFA goal date of July 17, 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07538843 |
An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatment |
NOT_YET_RECRUITING | |
| NCT07476677 |
Darolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07450599 |
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer. |
RECRUITING | PHASE2 |
| NCT07428642 |
PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC. |
COMPLETED | |
| NCT07406282 |
A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics |
RECRUITING | |
| NCT07244341 |
A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC) |
RECRUITING | PHASE1 |
| NCT07190300 |
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) |
RECRUITING | PHASE1/PHASE2 |
| NCT07142551 |
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response |
RECRUITING | PHASE2 |
| NCT07140900 |
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer |
RECRUITING | PHASE1 |
| NCT07027124 |
Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer |
RECRUITING | PHASE2 |
