^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Nubeqa (darolutamide)

    i
    Other names: ODM-201, BAY-1841788 , ODM 201, BAY 1841788
    Company:
    Bayer, Orion Corp
    Drug class:
    Androgen receptor inhibitor
    Related drugs:
    2d
    PSMA-DaroRT: PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC (clinicaltrials.gov)
    P2, N=254, Not yet recruiting, West China Hospital
    New P2 trial
    |
    Nubeqa (darolutamide)
    3d
    Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, Icahn School of Medicine at Mount Sinai | Trial primary completion date: Dec 2026 --> Dec 2027
    Trial primary completion date
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Prosigna® Breast Risk of Recurrence (ROR) Test • Decipher Prostate Cancer Test
    |
    Keytruda (pembrolizumab) • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • leuprolide acetate for depot suspension
    8d
    ETCTN 10553: Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers (clinicaltrials.gov)
    P2, N=21, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Apr 2027 --> Nov 2026 | Trial primary completion date: Apr 2027 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    Eligard (leuprolide acetate) • Nubeqa (darolutamide) • Viadur (leuprorelin implant)
    9d
    P300: A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC (clinicaltrials.gov)
    P1/2, N=120, Recruiting, Pathos AI, Inc. | N=252 --> 120
    Enrollment change
    |
    Nubeqa (darolutamide)
    17d
    QLC5508 in Advanced Solid Tumors:: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction (clinicaltrials.gov)
    P1, N=48, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
    New P1 trial
    |
    Nubeqa (darolutamide) • itraconazole • MHB088C • rifampicin
    17d
    PARIS-BIO: Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore (clinicaltrials.gov)
    P2, N=100, Recruiting, Region Stockholm
    New P2 trial
    |
    Nubeqa (darolutamide)
    21d
    AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) (clinicaltrials.gov)
    P3, N=670, Recruiting, AstraZeneca
    New P3 trial
    |
    FOLH1 positive
    |
    enzalutamide • abiraterone acetate • Nubeqa (darolutamide) • cabazitaxel • apalutamide • Xofigo (radium Ra-223 dichloride) • AiRuiEn (rezvilutamide) • FPI-2265 • prednisolone
    23d
    Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X) (clinicaltrials.gov)
    P2, N=66, Active, not recruiting, Sir Mortimer B. Davis - Jewish General Hospital | Recruiting --> Active, not recruiting | Trial completion date: Nov 2027 --> Nov 2030 | Trial primary completion date: Nov 2027 --> Nov 2030
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Nubeqa (darolutamide)
    23d
    EvoPAR-PR01: Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents (clinicaltrials.gov)
    P3, N=1889, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2028 --> Sep 2027
    Enrollment closed • Trial primary completion date
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    enzalutamide • abiraterone acetate • Nubeqa (darolutamide) • saruparib (AZD5305)
    24d
    23146: How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany (clinicaltrials.gov)
    P=N/A, N=500, Recruiting, Bayer | Not yet recruiting --> Recruiting
    Enrollment open • HEOR • Real-world evidence
    |
    Nubeqa (darolutamide)
    1m
    CHINANEO: 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. (clinicaltrials.gov)
    P2, N=250, Recruiting, Bayer | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Nubeqa (darolutamide) • goserelin acetate
    2ms
    ASCERTAIN: A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer. (clinicaltrials.gov)
    P1, N=120, Recruiting, AstraZeneca | Active, not recruiting --> Recruiting
    Enrollment open
    |
    Nubeqa (darolutamide) • saruparib (AZD5305)