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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:
    4d
    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
    16d
    Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study (clinicaltrials.gov)
    P2, N=194, Active, not recruiting, NRG Oncology | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Orgovyx (relugolix)
    16d
    VA STARPORT: Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (clinicaltrials.gov)
    P2/3, N=464, Recruiting, VA Office of Research and Development | Trial primary completion date: Mar 2026 --> Sep 2026
    Trial primary completion date
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • bicalutamide • apalutamide • triptorelin • goserelin acetate • flutamide • nilutamide • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    16d
    OPTYX: A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX (clinicaltrials.gov)
    P=N/A, N=999, Active, not recruiting, Sumitomo Pharma America, Inc. | Trial completion date: May 2028 --> Jul 2026 | Trial primary completion date: May 2028 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    Orgovyx (relugolix)
    16d
    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)
    1m
    Insights on Medical Therapy for Uterine Fibroids: A Review. (PubMed, Adv Ther)
    Oral GnRH antagonists, which include elagolix, relugolix, and linzagolix, signify a substantial progression, providing rapid and reversible suppression of ovarian hormone synthesis with dose-dependent effects and enhanced convenience. Innovative treatment modalities that target nonhormonal mechanisms, such as extracellular matrix remodeling, angiogenesis, and gene modulation, provide promising prospects for future uterus-sparing interventions. This narrative review evaluates the current and advancing landscape of medical therapies for uterine fibroids, presenting evidence-based perspectives to inform clinical decision-making within an increasingly personalized therapeutic context.
    Review • Journal
    |
    PGR (Progesterone receptor)
    |
    Orgovyx (relugolix) • Yselty (linzagolix)
    1m
    Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (clinicaltrials.gov)
    P2, N=60, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Eligard (leuprolide acetate) • Nubeqa (darolutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix)
    2ms
    CAMO959A12103: A clinical trial to learn about the effects of AMO959 given with AAA617 and an androgen receptor pathway inhibitor (ARPI) in adults with PSMA-positive prostate cancer that has spread to other parts of the body.athway inhibitor (ARPI) in adults with PSMA-positive prostate cancer that has spread to other parts of the body. (2025-521859-23-00)
    P1/2, N=61, Not yet recruiting, Novartis Pharma AG
    New P1/2 trial
    |
    Xtandi (enzalutamide) • abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Firmagon (degarelix) • Orgovyx (relugolix)
    2ms
    REDI-CaP (Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients). Innovative Management of Patients with Unfavorable Intermediate-Risk Prostate Cancer: a Special Focus on Quality of Life and Erectile Function Recovery (2025-521170-33-00)
    P1/2, N=50, Recruiting, IRCCS Istituto Nazionale Tumori Fondazione Pascale | Not yet recruiting --> Recruiting
    Enrollment open • HEOR
    |
    Orgovyx (relugolix)
    2ms
    RELAX: Relugolix for Endometriosis Associated Pain (clinicaltrials.gov)
    P=N/A, N=33, Not yet recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    New trial • Real-world evidence
    |
    Orgovyx (relugolix)
    2ms
    REVELUTION: RElugolix VErsus LeUprolide Cardiac Trial (clinicaltrials.gov)
    P2, N=94, Active, not recruiting, Emory University | Trial completion date: Dec 2025 --> Oct 2026
    Trial completion date
    |
    Orgovyx (relugolix) • leuprolide acetate for depot suspension
    3ms
    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)