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.
Bayer outlined its 2030 growth strategy at Pharma Media Day 2026, driven by AI partnerships, precision medicine, and a strengthened pipeline. The company aims for mid-single-digit growth from 2027 and 30% margins by 2030.
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 |
|---|---|---|---|
| NCT07730151 |
Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer. |
NOT_YET_RECRUITING | PHASE2 |
| NCT07723248 |
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1) |
RECRUITING | PHASE3 |
| NCT07711002 |
Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05) |
NOT_YET_RECRUITING | PHASE3 |
| NCT07620041 |
QLC5508 in Advanced Solid Tumors:: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction |
NOT_YET_RECRUITING | PHASE1 |
| NCT07617272 |
Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore |
RECRUITING | PHASE2 |
| NCT07611110 |
AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) |
RECRUITING | PHASE3 |
| 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 |
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 |
