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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:
    2d
    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
    2d
    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
    3d
    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)
    7d
    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)
    8d
    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)
    8d
    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)
    9d
    Saruparib in combination with androgen receptor pathway inhibitors in metastatic hormone-sensitive prostate cancer: EvoPAR-Prostate01. (PubMed, Future Oncol)
    Approximately 1800 participants (550 HRRm; 1250 non-HRRm) are randomized 1:1 to receive either saruparib plus physician's choice of ARPI (abiraterone plus prednisone/prednisolone, darolutamide, or enzalutamide) or placebo plus ARPI. Analyses of rPFS and OS will be conducted within each cohort by stratified log-rank test. Enrollment began in November 2023.Clinical trial registration: www.clinicaltrials.gov identifier is NCT06120491; EU CT number is 2023-504214-30-00.
    Clinical • Journal • PARP Biomarker
    |
    HRD (Homologous Recombination Deficiency)
    |
    Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • saruparib (AZD5305)
    9d
    CELC-G-201: Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1/2, N=54, Recruiting, Celcuity Inc | Trial completion date: Nov 2027 --> Jan 2030 | Trial primary completion date: Nov 2025 --> Jan 2028
    Trial completion date • Trial primary completion date
    |
    gedatolisib (PF-05212384) • Nubeqa (darolutamide)
    10d
    Update of S3 guideline on metastatic prostate cancer-guideline recommendations and expert consensus (PubMed, Urologie)
    In the hormone-sensitive setting (mHSPC), the combination of androgen deprivation therapy (ADT) with androgen receptor pathway inhibitors (ARPI) or abiraterone + prednis(ol)one (Abi), optionally combined with docetaxel, represents the current standard of care...Radioligand therapy with lutetium (177Lu) vipivotide tetraxetan has also gained increasing importance. It is indicated for mCRPC after prior treatment with ARPI/Abi and taxane chemotherapy, and may already play a role in the first-line mCRPC setting following treatment with darolutamide + ADT + docetaxel in mHSPC. This article presents current guideline recommendations for mHSPC and mCRPC, summarizes the underlying evidence, and provides practical guidance for treatment selection based on prior therapy and individual genetic profiles in order to support optimal decision-making in an increasingly complex therapeutic landscape.
    Review • Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
    |
    docetaxel • abiraterone acetate • Nubeqa (darolutamide) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    14d
    Safety and Efficacy of Docetaxel, Darolutamide, and Homoharringtonine Combined With Androgen Deprivation Therapy in Neoadjuvant Treatment of High-Risk Prostate Cancer: A Multicenter Prospective, Single-Arm Clinical Study (clinicaltrials.gov)
    P1, N=94, Not yet recruiting, Zhongda Hospital
    New P1 trial
    |
    docetaxel • Nubeqa (darolutamide) • goserelin acetate • Synribo (omacetaxine mepesuccinate)
    14d
    Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY) (clinicaltrials.gov)
    P2, N=57, Completed, National Cancer Center Hospital East | Active, not recruiting --> Completed
    Trial completion
    |
    AR (Androgen receptor)
    |
    AR positive
    |
    Nubeqa (darolutamide) • goserelin acetate
    14d
    Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial (clinicaltrials.gov)
    P3, N=2050, Active, not recruiting, NRG Oncology | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Nubeqa (darolutamide) • bicalutamide • triptorelin • goserelin acetate • flutamide • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension • Suprefact (buserelin acetate)