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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, 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, Recruiting, H. Lee Moffitt Cancer Center and Research Institute
    New P2 trial • Metastases
    |
    docetaxel • Xtandi (enzalutamide) • Nubeqa (darolutamide) • Erleada (apalutamide) • triptorelin • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    15d
    REVELUTION: RElugolix VErsus LeUprolide Cardiac Trial (clinicaltrials.gov)
    P4, N=93, Active, not recruiting, Emory University | Trial completion date: Jan 2026 --> Mar 2025
    Trial completion date
    |
    Orgovyx (relugolix) • leuprolide acetate for depot suspension
    17d
    Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED) (clinicaltrials.gov)
    P2, N=33, Recruiting, Atish Choudhury, MD | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Nubeqa (darolutamide) • Orgovyx (relugolix)
    23d
    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 Switzerland GmbH | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Orgovyx (relugolix)
    1m
    The University of Miami Adapt (UAdapt) Trial (clinicaltrials.gov)
    P2, N=130, Recruiting, University of Miami | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Orgovyx (relugolix)
    1m
    A multi-center clinical trial to evaluate the efficacy and safety of Relugolix Tablets in the treatment of advanced adrogen-sensitive prostate cancer (ChiCTR2400087806)
    P3, N=110, Recruiting, Cancer Hospital, Chinese Academy of Medical Sciences; Jiangxi Shanxiang Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Orgovyx (relugolix)
    1m
    Study of Relugolix in Men with Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=48, Completed, Sumitomo Pharma Switzerland GmbH | Active, not recruiting --> Completed | N=72 --> 48 | Trial completion date: May 2025 --> May 2024 | Trial primary completion date: May 2025 --> May 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    docetaxel • abiraterone acetate • prednisone • Erleada (apalutamide) • Orgovyx (relugolix) • Yonsa (abiraterone acetate)
    1m
    Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids (clinicaltrials.gov)
    P3, N=120, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
    New P3 trial
    |
    megestrol • Orgovyx (relugolix)
    2ms
    Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer (clinicaltrials.gov)
    P1, N=30, Recruiting, AdventHealth | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Nubeqa (darolutamide) • Orgovyx (relugolix)
    2ms
    NRG PROMETHEAN: Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer (clinicaltrials.gov)
    P2, N=260, Recruiting, NRG Oncology | Trial completion date: Oct 2029 --> Feb 2030 | Trial primary completion date: Oct 2024 --> Feb 2029
    Trial completion date • Trial primary completion date
    |
    Orgovyx (relugolix)
    2ms
    REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial (clinicaltrials.gov)
    P3, N=72, Not yet recruiting, Emory University
    New P3 trial • Metastases
    |
    abiraterone acetate • bicalutamide • Orgovyx (relugolix) • leuprolide acetate for depot suspension • Yonsa (abiraterone acetate)
    2ms
    Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial (clinicaltrials.gov)
    P2, N=50, Recruiting, Northwestern University | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Xtandi (enzalutamide) • Orgovyx (relugolix)
    2ms
    Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, AdventHealth
    New P1 trial • Metastases
    |
    Nubeqa (darolutamide) • Orgovyx (relugolix)
    3ms
    Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer (clinicaltrials.gov)
    P2, N=70, Recruiting, Ohio State University Comprehensive Cancer Center | Not yet recruiting --> Recruiting | Initiation date: Apr 2024 --> Aug 2024
    Enrollment open • Trial initiation date
    |
    Eligard (leuprolide acetate) • Orgovyx (relugolix)
    3ms
    A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients (clinicaltrials.gov)
    P1, N=60, Terminated, University of Chicago | N=100 --> 60 | Trial completion date: Apr 2025 --> Aug 2024 | Recruiting --> Terminated | Trial primary completion date: Apr 2025 --> Aug 2024; Terminated by the PI
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    itraconazole • Orgovyx (relugolix) • ritonavir
    3ms
    Study of Relugolix in Men with Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=72, Active, not recruiting, Sumitomo Pharma Switzerland GmbH | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2024 --> May 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    docetaxel • abiraterone acetate • prednisone • Erleada (apalutamide) • Orgovyx (relugolix) • Yonsa (abiraterone acetate)
    3ms
    Relugolix + Enzalutamide Study in High-Risk Prostate Cancer (clinicaltrials.gov)
    P1, N=41, Not yet recruiting, University of Oklahoma | Initiation date: Aug 2024 --> Dec 2024
    Trial initiation date • Metastases
    |
    Xtandi (enzalutamide) • Orgovyx (relugolix)
    3ms
    A multi-center clinical trial to evaluate the efficacy and safety of Relugolix Tablets in the treatment of advanced adrogen-sensitive prostate cancer (ChiCTR2400087806)
    P3, N=110, Not yet recruiting, Cancer Hospital, Chinese Academy of Medical Sciences; Jiangxi Shanxiang Pharmaceutical Co., Ltd.
    New P3 trial • Metastases
    |
    Orgovyx (relugolix)
    3ms
    Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED) (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, Atish Choudhury, MD | Trial completion date: Aug 2028 --> Nov 2028 | Initiation date: Aug 2024 --> Nov 2024 | Trial primary completion date: Aug 2028 --> Nov 2028
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Nubeqa (darolutamide) • Orgovyx (relugolix)
    4ms
    The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial (clinicaltrials.gov)
    P3, N=110, Recruiting, Main Line Health | Not yet recruiting --> Recruiting
    Enrollment open • Surgery
    |
    Orgovyx (relugolix)
    4ms
    The University of Miami Adapt (UAdapt) Trial (clinicaltrials.gov)
    P2, N=130, Not yet recruiting, University of Miami | N=80 --> 130
    Enrollment change
    |
    Orgovyx (relugolix)
    5ms
    Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer (clinicaltrials.gov)
    P2, N=32, Not yet recruiting, OHSU Knight Cancer Institute
    New P2 trial • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • bicalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    5ms
    Description of Relugolix Use in Patients With Prostate Cancer Within the VHA (clinicaltrials.gov)
    P=N/A, N=500, Active, not recruiting, Pfizer | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    Orgovyx (relugolix)
    5ms
    First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=32, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | Trial completion date: Jan 2027 --> Jul 2028 | Trial primary completion date: Jan 2027 --> Jul 2027
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    docetaxel • Tevimbra (tislelizumab-jsgr) • Xtandi (enzalutamide) • abiraterone acetate • triptorelin • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    5ms
    The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial (clinicaltrials.gov)
    P3, N=110, Not yet recruiting, Main Line Health | Trial completion date: Apr 2027 --> Aug 2026
    Trial completion date • Surgery
    |
    Orgovyx (relugolix)
    5ms
    Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Northwestern University
    New P2 trial
    |
    Xtandi (enzalutamide) • Orgovyx (relugolix)
    6ms
    Description of Relugolix Use in Patients With Prostate Cancer Within the VHA (clinicaltrials.gov)
    P=N/A, N=500, Not yet recruiting, Pfizer
    New trial
    |
    Orgovyx (relugolix)
    6ms
    Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED) (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, Atish Choudhury, MD
    New P2 trial
    |
    Nubeqa (darolutamide) • Orgovyx (relugolix)
    7ms
    Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial (clinicaltrials.gov)
    P2, N=120, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    7ms
    REVELUTION: RElugolix VErsus LeUprolide Cardiac Trial (clinicaltrials.gov)
    P4, N=93, Active, not recruiting, Emory University | Recruiting --> Active, not recruiting | Trial completion date: Apr 2025 --> Jan 2026 | Trial primary completion date: Apr 2024 --> Jan 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Orgovyx (relugolix) • leuprolide acetate for depot suspension
    7ms
    The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial (clinicaltrials.gov)
    P3, N=110, Not yet recruiting, Main Line Health
    New P3 trial • Surgery
    |
    Orgovyx (relugolix)
    7ms
    The University of Miami Adapt (UAdapt) Trial (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, University of Miami | Trial completion date: Jun 2032 --> Sep 2032 | Initiation date: Jun 2024 --> Sep 2024 | Trial primary completion date: Jun 2027 --> Sep 2027
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Orgovyx (relugolix)
    7ms
    Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=72, Active, not recruiting, Sumitomo Pharma Switzerland GmbH | Recruiting --> Active, not recruiting | Trial completion date: Nov 2023 --> May 2024 | Trial primary completion date: Jan 2023 --> May 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    docetaxel • abiraterone acetate • prednisone • Erleada (apalutamide) • Orgovyx (relugolix) • Yonsa (abiraterone acetate)
    7ms
    Relugolix + Enzalutamide Study in High-Risk Prostate Cancer (clinicaltrials.gov)
    P1, N=41, Not yet recruiting, University of Oklahoma | Initiation date: Apr 2024 --> Aug 2024
    Trial initiation date • Metastases
    |
    Xtandi (enzalutamide) • Orgovyx (relugolix)
    8ms
    ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer (clinicaltrials.gov)
    P3, N=392, Recruiting, NYU Langone Health
    New P3 trial
    |
    Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    8ms
    REPLACE-CV: Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate (clinicaltrials.gov)
    P3, N=2250, Active, not recruiting, Sumitomo Pharma Switzerland GmbH | Trial completion date: Feb 2027 --> Dec 2024 | Trial primary completion date: Feb 2027 --> Dec 2024
    Trial completion date • Trial primary completion date • Adverse events
    |
    Orgovyx (relugolix) • leuprolide acetate for depot suspension
    8ms
    Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Mayo Clinic
    New P2 trial • Metastases
    |
    Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    9ms
    Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer (clinicaltrials.gov)
    P2, N=70, Not yet recruiting, Ohio State University Comprehensive Cancer Center
    New P2 trial
    |
    Eligard (leuprolide acetate) • Orgovyx (relugolix)
    9ms
    OralT12: Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17 (clinicaltrials.gov)
    P1/2, N=10, Not yet recruiting, University of Washington
    New P1/2 trial
    |
    Orgovyx (relugolix)
    10ms
    SERENE: Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy (clinicaltrials.gov)
    P3, N=1020, Active, not recruiting, Myovant Sciences GmbH | Trial completion date: Apr 2025 --> Feb 2026 | Trial primary completion date: Apr 2024 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Orgovyx (relugolix)
    10ms
    Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, NorthShore University HealthSystem
    New P2 trial
    |
    Orgovyx (relugolix)
    10ms
    The SUGAR Study: (SBRT and Ultrashort GnRH Antagonist-Relugolix) for Clinicogenomic Unfavorable Intermediate Risk Prostate Cancer (clinicaltrials.gov)
    P2, N=60, Recruiting, Yale University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Orgovyx (relugolix)