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    DRUG CLASS:

    GnRH antagonist

    Related drugs:
    2d
    The University of Miami Adapt (UAdapt) Trial (clinicaltrials.gov)
    P2, N=130, Recruiting, University of Miami | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Orgovyx (relugolix)
    5d
    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)
    7d
    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)
    9d
    Cardiovascular Disease Risk in Women With Endometriosis (clinicaltrials.gov)
    P1, N=17, Recruiting, Yale University | Trial completion date: Aug 2025 --> Dec 2026 | Trial primary completion date: Aug 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
    11d
    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)
    15d
    A Study of Copanlisib in Combination with Degarelix in People with Prostate Cancer (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, Memorial Sloan Kettering Cancer Center | N=37 --> 0 | Active, not recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy
    |
    Aliqopa (copanlisib) • Firmagon (degarelix)
    16d
    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)
    18d
    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)
    23d
    A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking Methotrexate (clinicaltrials.gov)
    P2, N=72, Completed, Astellas Pharma Inc | Phase classification: P2a --> P2
    Phase classification
    |
    CRP (C-reactive protein)
    |
    methotrexate
    25d
    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)
    1m
    Comparison of 3 Different Protocols for Preventing Premature Ovulation in Ovarian Stimulation Cycles (clinicaltrials.gov)
    P=N/A, N=297, Completed, Bezmialem Vakif University | Recruiting --> Completed | Trial completion date: Mar 2024 --> Sep 2024 | Trial primary completion date: Mar 2024 --> Sep 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    Cetrotide (cetrorelix)
    1m
    Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain (clinicaltrials.gov)
    P3, N=800, Recruiting, AbbVie | Trial primary completion date: Dec 2024 --> Mar 2029
    Trial primary completion date • Combination therapy
    1m
    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 capsule) • Orgovyx (relugolix)
    1m
    A Study of Copanlisib in Combination with Degarelix in People with Prostate Cancer (clinicaltrials.gov)
    P1/2, N=37, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    Aliqopa (copanlisib) • Firmagon (degarelix)
    1m
    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)
    1m
    Androgen Deprivation Therapy Prior to Prostatectomy for Patients with Intermediate and High Risk Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=41, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Feb 2025 --> Sep 2024 | Trial primary completion date: Feb 2025 --> Sep 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    CASP3 (Caspase 3)
    |
    Firmagon (degarelix)
    1m
    Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    VIM (Vimentin) • CDH2 (Cadherin 2)
    |
    VIM expression
    |
    Mekinist (trametinib) • dasatinib • Xtandi (enzalutamide capsule) • Firmagon (degarelix)
    2ms
    FIRMAGON® Intensive Drug Monitoring (clinicaltrials.gov)
    P=N/A, N=1454, Completed, Ferring Pharmaceuticals | N=2193 --> 1454
    Enrollment change
    |
    Firmagon (degarelix)
    2ms
    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)
    2ms
    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
    2ms
    Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer. (clinicaltrials.gov)
    P2, N=52, Active, not recruiting, Medical University of South Carolina | Trial completion date: Sep 2024 --> Dec 2024
    Trial completion date • Metastases
    |
    docetaxel • Firmagon (degarelix)
    2ms
    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)
    2ms
    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 capsule) • Orgovyx (relugolix)
    2ms
    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)
    2ms
    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)
    2ms
    Androgen Deprivation Therapy Drives a Distinct Immune Phenotype in Localized Prostate Cancer. (PubMed, Clin Cancer Res)
    These observations underscore the critical role of timing and disease context in order to optimize the therapeutic efficacy of immune modulators combined with androgen ablation, for which the presurgical neoadjuvant setting may be ideal. Our findings warrant future prospective validation, which is currently underway.
    Journal
    |
    CD8 (cluster of differentiation 8)
    |
    Firmagon (degarelix)
    3ms
    Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer (clinicaltrials.gov)
    P3, N=56, Terminated, Memorial Sloan Kettering Cancer Center | Completed --> Terminated; Due to low accrual
    Trial termination
    |
    Firmagon (degarelix)
    3ms
    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)
    3ms
    A Study Evaluating Food Effect on Pharmacokinetics of HS-10518 (clinicaltrials.gov)
    P1, N=8, Not yet recruiting, Jiangsu Hansoh Pharmaceutical Co., Ltd.
    New P1 trial
    3ms
    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)
    3ms
    TUC3PII-01_TU2670 Phase IIa Clinical Study (clinicaltrials.gov)
    P2, N=86, Completed, TiumBio Co., Ltd. | Recruiting --> Completed | Phase classification: P2a --> P2 | Trial completion date: Dec 2023 --> Aug 2024 | Trial primary completion date: Sep 2023 --> Jan 2024
    Trial completion • Phase classification • Trial completion date • Trial primary completion date
    3ms
    To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects (clinicaltrials.gov)
    P3, N=317, Active, not recruiting, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed • Head-to-Head
    |
    SHR7280
    3ms
    PRESTO: A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer (clinicaltrials.gov)
    P3, N=504, Active, not recruiting, Alliance Foundation Trials, LLC. | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    abiraterone acetate • prednisone • bicalutamide • Erleada (apalutamide) • Firmagon (degarelix) • leuprolide acetate for depot suspension
    4ms
    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)
    4ms
    A Study to Evaluate the Mass Balance of [14C]SHR7280 in Healthy Adult Volunteers (clinicaltrials.gov)
    P1, N=6, Completed, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Completed
    Trial completion
    |
    SHR7280
    4ms
    Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (clinicaltrials.gov)
    P3, N=478, Completed, AbbVie | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    4ms
    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)
    4ms
    Effect of modified GnRH antagonist protocol on the outcome of in vitro fertilization in patients with normal ovarian response (ChiCTR2100053453)
    P=N/A, N=546, Completed, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; Tongji Hospital, Tongji Medical College, Huazhong University o | Recruiting --> Completed
    Trial completion
    |
    Cetrotide (cetrorelix)
    4ms
    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 capsule) • Orgovyx (relugolix)
    4ms
    Inflammatory Changes after Medical Suppression of Suspected Endometriosis for Implantation Failure: Preliminary Results. (PubMed, Int J Mol Sci)
    Based on these and previous promising results, we next performed a pilot randomized controlled trial comparing the orally active GnRH antagonist, elagolix, to oral contraceptive pill (OCP) suppression for 2 months before the next euploid embryo transfer, and monitored inflammation and miRNA expression in blood, before and after treatment. These studies support a role for endometriosis in UEETF and suggest that medical suppression of suspected disease with GnRH antagonist prior to the next transfer could improve success rates and address underlying inflammatory and epigenetic changes associated with UEETF.
    Clinical • Journal
    |
    BCL6 (B-cell CLL/lymphoma 6)
    4ms
    Neo-Red-P: Non-fucosylated Anti-CTLA-4 (BMS-986218) + Degarelix Acetate vs. Degarelix Acetate Alone in Men With High-risk Localized Prostate Cancer (clinicaltrials.gov)
    P1, N=26, Active, not recruiting, Columbia University | Trial primary completion date: Jun 2024 --> Jun 2025
    Trial primary completion date
    |
    Firmagon (degarelix) • BMS-986218
    4ms
    The Pharmacokinetic(PK)/Pharmacodynamics(PD) Study of SHR7280 Tablets in Premenopausal Subjects With Endometriosis. (clinicaltrials.gov)
    P1/2, N=179, Completed, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Completed | Trial completion date: Jan 2024 --> May 2024 | Trial primary completion date: Jan 2024 --> May 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    SHR7280