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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:
    4d
    Therapeutic Advances in Metastatic Prostate Cancer: A Journey from Standard of Care to New Emerging Treatment. (PubMed, Int J Mol Sci)
    We detail the evidence supporting the integration of systemic agents like abiraterone, enzalutamide, and darolutamide into both hormone-sensitive and castration-resistant settings. Furthermore, we highlight the expanding role of radioligand therapies, including radium-223 and Lutetium-177-labeled PSMA-617 (Lu-PSMA-617), as well as the growing impact of PARP inhibitors in genomically selected patients. The emergence of theranostic strategies and next-generation sequencing has paved the way for personalized treatment algorithms, moving toward a truly precision oncology model in PCa. This comprehensive review synthesizes current therapeutic strategies, clinical trial evidence, and future directions aimed at optimizing outcomes and quality of life for patients with advanced prostate cancer.
    Review • Journal • BRCA Biomarker • PARP Biomarker
    |
    TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog)
    |
    TP53 mutation • PTEN mutation
    |
    Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • apalutamide • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Xofigo (radium Ra-223 dichloride)
    6d
    PETRANHA: Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (clinicaltrials.gov)
    P1/2, N=174, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • apalutamide • saruparib (AZD5305)
    9d
    An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea (clinicaltrials.gov)
    P=N/A, N=600, Recruiting, Bayer | Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Mar 2026 --> Mar 2028
    Trial completion date • Trial primary completion date
    |
    Nubeqa (darolutamide)
    12d
    Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=25, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | Trial completion date: Jan 2027 --> Nov 2028 | Trial primary completion date: Jan 2027 --> Nov 2028
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    docetaxel • Xtandi (enzalutamide) • Nubeqa (darolutamide) • apalutamide • triptorelin • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    19d
    TulmiSTAR-02: A 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) (clinicaltrials.gov)
    P1/2, N=203, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open
    |
    abiraterone acetate • Nubeqa (darolutamide) • tulmimetostat (DZR123)
    20d
    A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P1, N=60, Not yet recruiting, Daiichi Sankyo
    New P1 trial
    |
    Nubeqa (darolutamide) • Ezharmia (valemetostat)
    20d
    PRO-MIND: Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=102, Recruiting, Ankara Etlik City Hospital | Not yet recruiting --> Recruiting
    Enrollment open • HEOR
    |
    Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • apalutamide
    25d
    ARASTEP: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies (clinicaltrials.gov)
    P3, N=977, Active, not recruiting, Bayer | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Nubeqa (darolutamide)
    1m
    Advances in Prostate Cancer Treatment: Exploring Molecular Targets and New Strategies in Castration-Resistant Disease. (PubMed, Cureus)
    Key developments include next-generation AR pathway inhibitors, such as darolutamide, with improved safety profiles; PARP inhibitors for patients with DNA repair gene mutations; and PSMA-targeted radioligand therapy. The therapeutic landscape is also expanding to include novel targets such as the heat shock response, with HSF1 inhibitors like NXP800 in clinical trials for treatment-refractory disease. By targeting this molecular heterogeneity, ongoing research aims to deliver more effective, personalized treatments to improve survival and quality of life for men with advanced prostate cancer.
    Review • Journal • PARP Biomarker
    |
    AR (Androgen receptor) • HSF1 (Heat Shock Transcription Factor 1)
    |
    Nubeqa (darolutamide) • NXP800
    1m
    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) | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Eligard (leuprolide acetate) • Nubeqa (darolutamide) • Viadur (leuprorelin implant)
    1m
    Cost-effectiveness analysis of second-generation androgen receptor antagonists for the treatment of metastatic hormone-sensitive prostate cancer. (PubMed, Front Public Health)
    Compared to apalutamide, the ICER for enzalutamide was ¥643,309/QALY, while for darolutamide, the ICER was -¥40,625/QALY. For Chinese mHSPC patients, darolutamide is the most cost-effective treatment at a WTP threshold of ¥287,391/QALY, followed by apalutamide, with enzalutamide being less favorable.
    Journal • HEOR • Cost-effectiveness
    |
    AR (Androgen receptor)
    |
    Xtandi (enzalutamide) • Nubeqa (darolutamide) • apalutamide
    1m
    The effect of Darolutamide Plus Active Surveillance vs Active Surveillance in Patients with Low-risk Localized Prostate Cancer: a Randomized Controlled Trial (ChiCTR2500109241)
    P=N/A, N=184, Not yet recruiting, Peking University First Hospital; Peking University First Hospital
    New trial
    |
    Nubeqa (darolutamide)