^
    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:
    10d
    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)
    11d
    A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P1, N=60, Recruiting, Daiichi Sankyo | N=13 --> 60
    Enrollment change • Trial initiation date
    |
    KLK3 (Kallikrein-related peptidase 3)
    |
    Nubeqa (darolutamide) • Ezharmia (valemetostat)
    17d
    PICASSO: Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction (clinicaltrials.gov)
    P2, N=4, Completed, St Vincent's Hospital, Sydney | Recruiting --> Completed | N=22 --> 4
    Trial completion • Enrollment change
    |
    dasatinib • Nubeqa (darolutamide)
    18d
    Prospective Single-Arm Study of Prostate Cytoreductive Surgery in Combination with ADT + Darotarotide + Docetaxel for the Treatment of New Oligometastatic Hormone-Sensitive Prostate Cancer (Phase II Clinical Trial) (ChiCTR2600121389)
    P2, N=30, The First Affiliated Hospital of Sun Yat-sen University; The First Affiliated Hospital of Sun Yat-sen University
    New P2 trial
    |
    docetaxel • Nubeqa (darolutamide)
    18d
    A real-world retrospective study evaluating the ADT combined with docetaxel and darolutamide triple therapy regimen for metastatic prostate cancer(YHCG-006) (ChiCTR2600118253)
    P4, N=111, The First Affiliated Hospital of Ningbo University; The First Affiliated Hospital of Ningbo University
    New P4 trial • Real-world evidence
    |
    docetaxel • Nubeqa (darolutamide)
    19d
    Prostate cancer presenting as brain metastasis with concurrent elevation of carcinoembryonic antigen and carbohydrate antigen 19-9 levels: illustrative case. (PubMed, J Neurosurg Case Lessons)
    Brain metastases from prostate cancer with elevated CEA and CA19-9 are rare. Although these markers often indicate a poor prognosis, this patient achieved a favorable outcome with multimodal treatment. https://thejns.org/doi/10.3171/CASE25735.
    Journal
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5) • CA 19-9 (Cancer antigen 19-9) • NKX3-1 (NK3 homeobox 1)
    |
    docetaxel • Nubeqa (darolutamide) • leuprolide acetate for depot suspension
    20d
    DARE: 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 (clinicaltrials.gov)
    P=N/A, N=800, Not yet recruiting, Bayer
    New trial • Real-world evidence
    |
    Nubeqa (darolutamide) • bicalutamide
    20d
    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 (clinicaltrials.gov)
    P2, N=532, Recruiting, Mayo Clinic | Trial completion date: May 2029 --> Feb 2031 | Trial primary completion date: May 2029 --> Feb 2031
    Trial completion date • Trial primary completion date
    |
    Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • apalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    21d
    Stereotactic body radiotherapy with or without Darolutamide for OligoRecurrent prostate cancer: a randomized phase II trial (DART) (2024-511140-37-00)
    P1/2, N=140, Completed, Universitair Ziekenhuis Gent | Active, not recruiting --> Completed
    Trial completion
    |
    FOLH1 positive
    |
    Nubeqa (darolutamide)
    25d
    ARAMIS Rollover: Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer (clinicaltrials.gov)
    P3, N=402, Active, not recruiting, Bayer | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Nubeqa (darolutamide)
    26d
    SNV1521-101: SNV1521 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=400, Recruiting, Synnovation Therapeutics, Inc. | N=200 --> 400 | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2026 --> Dec 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    abiraterone acetate • Nubeqa (darolutamide)
    26d
    A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described (clinicaltrials.gov)
    P=N/A, N=805, Active, not recruiting, Bayer | Trial primary completion date: Jul 2026 --> Dec 2026
    Trial primary completion date
    |
    Nubeqa (darolutamide)