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    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:
    3d
    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, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Nubeqa (darolutamide) • saruparib (AZD5305)
    5d
    ROAD: A Study to Learn How Men With Advanced Prostate Cancer Respond to Treatment With Darolutamide and Hormone Therapy, With or Without Chemotherapy, in Real-world Medical Practice (clinicaltrials.gov)
    P=N/A, N=1600, Active, not recruiting, Bayer | Not yet recruiting --> Active, not recruiting
    Enrollment closed • Real-world evidence
    |
    docetaxel • Nubeqa (darolutamide)
    6d
    A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer (clinicaltrials.gov)
    P1, N=300, Recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2027 --> May 2028 | Trial primary completion date: Jun 2026 --> Aug 2027
    Trial completion date • Trial primary completion date
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • cabazitaxel • apalutamide • cetrelimab (JNJ-63723283) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • pasritamig (JNJ-8343)
    6d
    Double-DARE: 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 (clinicaltrials.gov)
    P=N/A, N=1400, Recruiting, Bayer | Trial completion date: Feb 2026 --> May 2026 | Trial primary completion date: Feb 2026 --> May 2026
    Trial completion date • Trial primary completion date • Real-world evidence
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • apalutamide
    18d
    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 | Not yet recruiting --> Recruiting | Initiation date: Jun 2025 --> Mar 2026
    Enrollment open • Trial initiation date
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • Decipher Prostate Cancer Test
    |
    Keytruda (pembrolizumab) • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • leuprolide acetate for depot suspension
    20d
    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) (clinicaltrials.gov)
    P4, N=50, Recruiting, Bayer | Trial completion date: Jan 2026 --> Apr 2027 | Trial primary completion date: Jan 2026 --> Apr 2027
    Trial completion date • Trial primary completion date • Real-world evidence
    |
    Nubeqa (darolutamide)
    21d
    Clinical Application of the Androgen Receptor Inhibitor Darolutamide to Upregulate the Prostate-Specific Membrane Antigen (PSMA) Protein Expression in Patients with Hormone Sensitive Prostate Cancer. n- The DARO-flare Trial - (2025-520482-52-03)
    P1/2, N=32, Not yet recruiting, Amsterdam UMC Stichting | N=16 --> 32
    Enrollment change
    |
    Nubeqa (darolutamide)
    21d
    DS3201-343: Phase 1 trial of valemetostat and darolutamide in mCRPC (2025-522512-16-00)
    P1, N=4, Not yet recruiting, Daiichi Sankyo Inc.
    New P1 trial
    |
    Nubeqa (darolutamide) • Ezharmia (valemetostat)
    21d
    ANDARP: Darolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate Cancer (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P2 trial
    |
    Nubeqa (darolutamide)
    28d
    Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (clinicaltrials.gov)
    P2, N=60, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Eligard (leuprolide acetate) • Nubeqa (darolutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix)
    1m
    Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment (clinicaltrials.gov)
    P1, N=10, Completed, Eli Lilly and Company | Active, not recruiting --> Completed | Trial completion date: Jul 2026 --> Jan 2026
    Trial completion • Trial completion date
    |
    Verzenio (abemaciclib) • Nubeqa (darolutamide)
    1m
    DAROTAXEL (2024-516939-28-00`2022-003792-41)
    P1/2, N=245, Recruiting, Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    docetaxel • Nubeqa (darolutamide) • cabazitaxel