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    DRUG:

    Orgovyx (relugolix)

    i
    Other names: RVT-601, TAK 385 , TAK-385, RVT 601, MVT-601, T-1331285, MVT 601, MVT601, T 1331285, T1331285, RVT601, TAK385
    Company:
    ASKA Pharma, Gedeon Richter, Intas, Knight Therap, Pfizer, Sumitomo Pharma, Takeda
    Drug class:
    GnRH antagonist
    Related drugs:
    6d
    APEX: Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial primary completion date
    |
    Xtandi (enzalutamide) • Eligard (leuprolide acetate) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix)
    7d
    Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial (clinicaltrials.gov)
    P2, N=30, Recruiting, Mayo Clinic | Trial completion date: Jul 2026 --> Dec 2026 | Trial primary completion date: Jul 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Orgovyx (relugolix)
    12d
    Insights in Endocervical Mucus Secretion (clinicaltrials.gov)
    P4, N=15, Recruiting, Oregon Health and Science University | Not yet recruiting --> Recruiting | Initiation date: Aug 2025 --> Jan 2026
    Enrollment open • Trial initiation date
    |
    Orgovyx (relugolix)
    25d
    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 | N=220 --> 532
    Enrollment change
    |
    Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • apalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    2ms
    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
    2ms
    Case Report: Cutaneous metastatic mucin-producing prostate adenocarcinoma. (PubMed, Front Oncol)
    He was started on androgen deprivation therapy with relugolix...It also raises awareness of prostate cancer presenting as solitary cutaneous metastasis and calls attention to the potential value of PSA screening in select elderly patients. Recognizing uncommon cutaneous manifestations may lead to earlier diagnosis and improved management of advanced internal malignancies.
    Journal
    |
    NKX2-1 (NK2 Homeobox 1) • PAX8 (Paired box 8) • NKX3-1 (NK3 homeobox 1)
    |
    Orgovyx (relugolix)
    3ms
    OPTIMAS: Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=160, Recruiting, University of Utah | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Orgovyx (relugolix)
    3ms
    OPTIMAS: Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=160, Not yet recruiting, University of Utah
    New P2 trial
    |
    Orgovyx (relugolix)
    4ms
    Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, OHSU Knight Cancer Institute | N=32 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • bicalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    4ms
    REVELUTION: RElugolix VErsus LeUprolide Cardiac Trial (clinicaltrials.gov)
    P2, N=94, Active, not recruiting, Emory University | Trial completion date: Jun 2025 --> Dec 2025
    Trial completion date
    |
    Orgovyx (relugolix) • leuprolide acetate for depot suspension
    4ms
    Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain (clinicaltrials.gov)
    P3, N=130, Recruiting, University of Michigan | Initiation date: Aug 2025 --> Nov 2025
    Trial initiation date
    |
    CCL3 (C-C Motif Chemokine Ligand 3)
    |
    Orgovyx (relugolix)
    4ms
    The COSMYC Trial (COmbined Suppression of MYC) (clinicaltrials.gov)
    P2, N=50, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Xtandi (enzalutamide) • Eligard (leuprolide acetate) • triptorelin • goserelin acetate • ZEN-3694 • Firmagon (degarelix) • Orgovyx (relugolix)