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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:
    1d
    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)
    2d
    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
    3d
    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, Not yet recruiting, Bayer
    New P2 trial
    |
    Nubeqa (darolutamide) • goserelin acetate
    7d
    ARANOTE: Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (clinicaltrials.gov)
    P3, N=669, Completed, Bayer | Active, not recruiting --> Completed
    Trial completion
    |
    Nubeqa (darolutamide)
    11d
    Transcriptomic analysis to uncover the mechanism of radiosensitization of AR-positive triple-negative breast cancers with AR inhibition. (PubMed, NPJ Breast Cancer)
    Mechanistically, while stimulation with the AR-agonist R1881 is sufficient to induce nuclear translocation of AR in AR+ TNBC cells, AR inhibition with enzalutamide, apalutamide, or darolutamide blocked AR nuclear translocation. These findings suggest that AR-mediated radioresistance is at least partially due to downstream MAPK/ERK signaling. Together this work builds on the mechanistic understanding of AR-mediated radioresistance in AR+ TNBC which may expose vulnerabilities in resistance to combination treatment with AR inhibition and RT.
    Journal
    |
    AR (Androgen receptor)
    |
    AR positive
    |
    Xtandi (enzalutamide) • Nubeqa (darolutamide) • apalutamide
    17d
    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=16, Not yet recruiting, Amsterdam UMC Stichting
    New P1/2 trial
    |
    Nubeqa (darolutamide)
    17d
    CDZR123C12101: TulmiSTAR-02: 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) (2025-521873-15-00)
    P1/2, N=54, Recruiting, Novartis Pharma AG
    New P1/2 trial
    |
    abiraterone acetate • Nubeqa (darolutamide) • tulmimetostat (DZR123)
    22d
    A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer (clinicaltrials.gov)
    P1, N=277, Recruiting, Janssen Research & Development, LLC | N=185 --> 277
    Enrollment change
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • cabazitaxel • apalutamide • cetrelimab (JNJ-63723283) • pasritamig (JNJ-8343)
    22d
    Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression (clinicaltrials.gov)
    P1, N=9, Active, not recruiting, Beth Israel Deaconess Medical Center | Recruiting --> Active, not recruiting | N=15 --> 9 | Trial completion date: Feb 2026 --> Sep 2026
    Enrollment closed • Enrollment change • Trial completion date
    |
    Xtandi (enzalutamide) • Nubeqa (darolutamide) • apalutamide
    22d
    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
    New trial • Real-world evidence
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • apalutamide
    22d
    Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial) (clinicaltrials.gov)
    P2, N=51, Active, not recruiting, Latin American Cooperative Oncology Group | Trial completion date: Jun 2025 --> Jun 2026
    Trial completion date
    |
    Nubeqa (darolutamide)
    24d
    Syndrome of Inappropriate Antidiuretic Hormone Secretion and Thrombotic Microangiopathy as Paraneoplastic Syndromes Complicating BRCA2-Mutated Metastatic Prostate Cancer. (PubMed, Cureus)
    He was treated with free water restriction, hypertonic saline, and triplet systemic therapy (docetaxel, androgen deprivation, and darolutamide) and discharged in stable condition. Management of these complications requires addressing the underlying cancer with definitive treatment. The case highlights the vigilance for atypical paraneoplastic manifestations, the need for early genomic testing, and the exploration of novel therapeutic strategies in BRCA2-driven prostate cancer.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation
    |
    docetaxel • Nubeqa (darolutamide)