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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:
    3d
    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
    10d
    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)
    1m
    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)
    2ms
    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)
    2ms
    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    P2, N=0, Withdrawn, OHSU Knight Cancer Institute | N=32 --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 Withdrawn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
    2ms
    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
    3ms
    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)
    3ms
    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)
    3ms
    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 | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Orgovyx (relugolix)
    3ms
    Two Studies for Patients With High 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 High Gene Risk Score, The PREDICT-RT Trial (clinicaltrials.gov)
    P3, N=2753, Active, not recruiting, NRG Oncology | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD4 (CD4 Molecule)
    |
    bicalutamide • apalutamide • triptorelin • goserelin acetate • flutamide • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension • Suprefact (buserelin acetate)
    3ms
    Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    New P2 trial
    |
    Eligard (leuprolide acetate) • Nubeqa (darolutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix)
    4ms
    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, Not yet recruiting, Mayo Clinic | Initiation date: Jul 2025 --> Oct 2025
    Trial initiation date
    |
    Orgovyx (relugolix)