Darolutamide: clinical trials recruiting now
24
Recruiting trials
15
Conditions studied
31
US states with sites
29
Countries
FDA drug label
- FDA-approved
- Yes. Darolutamide appears in the FDA drug-label database. Marketed as NUBEQA.
FDA-approved use
NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. ( 1 ) NUBEQA is indicated for the treatment of adult patients with: non-metastatic castration resistant prostate cancer (nmCRPC) metastatic castration-sensitive prostate cancer (mCSPC) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
Phase breakdown
Phase 1 7
Phase 2 13
Phase 3 5
Not applicable 2
Conditions being studied
Recruiting trials involving Darolutamide
- A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer
- A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
- 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
- A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
- 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.
- AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
- Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer
- 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
- Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC
- Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
- Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer
- Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC
- Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
- Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
- ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
- Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore
- Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
- Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse
- Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
- Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
- Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
- Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers
- 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)
Common questions
Is Darolutamide FDA-approved?
Yes, marketed as NUBEQA.
How many recruiting trials involve Darolutamide?
24 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.