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    DRUG:

    Eligard (leuprolide acetate)

    i
    Other names: SOU 375, LA 2575, SOT-375, TOL2506, LA2575, LA-2575, SOT375, SOT 375, SOU375, SOU-375, TOL 2506, TOL-2506
    Company:
    Daewoong Pharma, Recordati, Sanofi, Tolmar
    Drug class:
    GnRH agonist
    Related drugs:
    23d
    RATIONAL-PCS: Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC) (clinicaltrials.gov)
    P2, N=162, Not yet recruiting, Ontario Clinical Oncology Group (OCOG)
    New P2 trial • Metastases
    |
    Eligard (leuprolide acetate)
    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
    ImmunoADAPT: Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov)
    P2, N=33, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Jul 2024 --> Mar 2025
    Trial primary completion date
    |
    ER (Estrogen receptor)
    |
    ER positive
    |
    Ibrance (palbociclib) • tamoxifen • Bavencio (avelumab) • Eligard (leuprolide acetate) • goserelin acetate
    3ms
    Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=14, Recruiting, Roswell Park Cancer Institute | Trial completion date: Apr 2027 --> Oct 2027 | Trial primary completion date: Apr 2026 --> Oct 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    Eligard (leuprolide acetate) • Viadur (leuprorelin implant)
    3ms
    Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (clinicaltrials.gov)
    P1/2, N=9, Active, not recruiting, Praful Ravi, MB BCHir, MRCP | N=93 --> 9
    Enrollment change
    |
    Verzenio (abemaciclib) • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • goserelin acetate • Firmagon (degarelix)
    3ms
    OVELIA: Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer (clinicaltrials.gov)
    P3, N=250, Recruiting, Tolmar Inc. | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Apr 2025 --> Apr 2026
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    tamoxifen • letrozole • anastrozole • exemestane • Eligard (leuprolide acetate)
    4ms
    Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (clinicaltrials.gov)
    P1/2, N=93, Active, not recruiting, Praful Ravi, MB BCHir, MRCP | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial primary completion date
    |
    Verzenio (abemaciclib) • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • goserelin acetate • Firmagon (degarelix)
    4ms
    Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy (clinicaltrials.gov)
    P2, N=118, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Jun 2024 --> Dec 2024
    Trial completion date
    |
    abiraterone acetate • prednisone • Eligard (leuprolide acetate) • Erleada (apalutamide)
    4ms
    NRG-GU002: Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery (clinicaltrials.gov)
    P2/3, N=612, Active, not recruiting, NRG Oncology | N=175 --> 612 | Trial completion date: May 2031 --> May 2026
    Enrollment change • Trial completion date • Surgery
    |
    docetaxel • Eligard (leuprolide acetate) • bicalutamide • goserelin acetate • flutamide • nilutamide • Firmagon (degarelix) • Viadur (leuprorelin implant)
    7ms
    NRG-GY033: Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors (clinicaltrials.gov)
    P2, N=37, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension • Combination therapy
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    exemestane • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • Viadur (leuprorelin implant)
    7ms
    Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=14, Recruiting, Roswell Park Cancer Institute | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Eligard (leuprolide acetate) • Viadur (leuprorelin implant)
    7ms
    The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's (clinicaltrials.gov)
    P2, N=180, Recruiting, Weill Medical College of Cornell University | Trial primary completion date: Feb 2025 --> Dec 2025
    Trial primary completion date
    |
    Eligard (leuprolide acetate)
    8ms
    ImmunoADAPT: Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov)
    P2, N=33, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Jul 2024
    Trial completion date • Trial primary completion date
    |
    ER (Estrogen receptor)
    |
    ER positive
    |
    Ibrance (palbociclib) • tamoxifen • Bavencio (avelumab) • Eligard (leuprolide acetate) • goserelin acetate
    8ms
    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)
    8ms
    Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=14, Not yet recruiting, Roswell Park Cancer Institute
    New P1 trial • Metastases
    |
    Eligard (leuprolide acetate) • Viadur (leuprorelin implant)
    9ms
    ADOPT: Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy (clinicaltrials.gov)
    P3, N=280, Recruiting, University Medical Center Groningen | Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    Eligard (leuprolide acetate)
    9ms
    Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (clinicaltrials.gov)
    P1/2, N=93, Active, not recruiting, Praful Ravi, MB BCHir, MRCP | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Verzenio (abemaciclib) • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • goserelin acetate • Firmagon (degarelix)
    9ms
    THUNDER: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (clinicaltrials.gov)
    P2/3; N=493; Recruiting; Sponsor:Cancer Research Antwerp
    New P2/3 trial
    |
    Decipher Prostate Cancer Test
    |
    docetaxel • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • triptorelin • goserelin acetate • Firmagon (degarelix)
    9ms
    Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer (clinicaltrials.gov)
    P2, N=29, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Metastases
    |
    Eligard (leuprolide acetate) • bicalutamide • goserelin acetate • Viadur (leuprorelin implant)
    9ms
    NRG-GY033: Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors (clinicaltrials.gov)
    P2, N=37, Recruiting, National Cancer Institute (NCI) | Initiation date: Oct 2024 --> Feb 2024
    Trial initiation date • Combination therapy
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    exemestane • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • Viadur (leuprorelin implant)
    9ms
    SATURN: Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer (clinicaltrials.gov)
    P2, N=28, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    abiraterone acetate • Eligard (leuprolide acetate) • Erleada (apalutamide) • Viadur (leuprorelin implant)
    9ms
    A Study Called AWARENESS Using Data From Men in Alberta to Observe Treatment Patterns for Metastatic Castration-sensitive Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=960, Completed, Bayer | Active, not recruiting --> Completed
    Trial completion
    |
    docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • Eligard (leuprolide acetate) • triptorelin • goserelin acetate • cyproterone acetate
    9ms
    NRG-GY033: Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors (clinicaltrials.gov)
    P2, N=37, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    exemestane • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • Viadur (leuprorelin implant)
    10ms
    Real-life Evaluation of the Effect of ADT in Prostate Cancer Patients in Asia (READT Asia Study) (clinicaltrials.gov)
    P=N/A, N=300, Active, not recruiting, Chinese University of Hong Kong | Recruiting --> Active, not recruiting | N=600 --> 300
    Enrollment closed • Enrollment change
    |
    Eligard (leuprolide acetate) • Firmagon (degarelix)
    11ms
    Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=70, Recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Aug 2027 | Trial primary completion date: Dec 2023 --> Aug 2027
    Trial completion date • Trial primary completion date
    |
    Talzenna (talazoparib) • abiraterone acetate • Eligard (leuprolide acetate) • bicalutamide • goserelin acetate • Firmagon (degarelix) • Viadur (leuprorelin implant) • Yonsa (abiraterone acetate)
    11ms
    Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy (clinicaltrials.gov)
    P2, N=118, Active, not recruiting, Dana-Farber Cancer Institute
    Trial completion date • Trial primary completion date
    |
    abiraterone acetate • prednisone • Eligard (leuprolide acetate) • Erleada (apalutamide)
    11ms
    Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study (clinicaltrials.gov)
    P3, N=250, Enrolling by invitation, Tolmar Inc.
    Trial completion date • Trial primary completion date
    |
    tamoxifen • letrozole • anastrozole • exemestane • Eligard (leuprolide acetate)
    11ms
    Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors (clinicaltrials.gov)
    P2, N=37, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    exemestane • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • Viadur (leuprorelin implant)
    12ms
    Testing the Anti-Cancer Drug Darolutamide in Patients With Testosterone-driven Salivary Gland Cancers (clinicaltrials.gov)
    P2, N=20, Recruiting, National Cancer Institute (NCI) | Initiation date: Jan 2024 --> Jul 2023
    Trial initiation date • Combination therapy • Metastases
    |
    AR (Androgen receptor)
    |
    AR positive • AR expression
    |
    Eligard (leuprolide acetate) • Nubeqa (darolutamide) • Viadur (leuprorelin implant)
    12ms
    Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer (clinicaltrials.gov)
    P2, N=25, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Apr 2025 | Trial primary completion date: Dec 2023 --> Apr 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Eligard (leuprolide acetate) • goserelin acetate • Firmagon (degarelix) • Xofigo (radium Ra-223 dichloride) • Viadur (leuprorelin implant)
    1year
    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 | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Xtandi (enzalutamide capsule) • Eligard (leuprolide acetate) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix)
    1year
    Testing the Anti-Cancer Drug Darolutamide in Patients With Testosterone-driven Salivary Gland Cancers (clinicaltrials.gov)
    P2, N=20, Recruiting, National Cancer Institute (NCI) | Initiation date: Oct 2023 --> Jan 2024
    Trial initiation date • Combination therapy • Metastases
    |
    AR expression
    |
    Eligard (leuprolide acetate) • Nubeqa (darolutamide) • Viadur (leuprorelin implant)
    over1year
    Testing the Anti-Cancer Drug Darolutamide in Patients With Testosterone-driven Salivary Gland Cancers (clinicaltrials.gov)
    P2, N=20, Recruiting, National Cancer Institute (NCI) | Initiation date: Jul 2023 --> Oct 2023
    Trial initiation date • Combination therapy • Metastases
    |
    AR expression
    |
    Eligard (leuprolide acetate) • Nubeqa (darolutamide) • Viadur (leuprorelin implant)
    over1year
    Testing the Anti-Cancer Drug Darolutamide in Patients With Testosterone-driven Salivary Gland Cancers (clinicaltrials.gov)
    P2, N=20, Recruiting, National Cancer Institute (NCI) | Initiation date: Apr 2023 --> Jul 2023
    Trial initiation date • Combination therapy • Metastases
    |
    AR expression
    |
    Eligard (leuprolide acetate) • Nubeqa (darolutamide) • Viadur (leuprorelin implant)
    over1year
    LBA02-09 EMBARK: A Phase 3 Randomized Study of Enzalutamide or Placebo Plus Leuprolide Acetate and Enzalutamide Monotherapy in High-risk Biochemically Recurrent Prostate Cancer. (PubMed, J Urol)
    In pts with high-risk BCR, enza + ADT and enza mono demonstrated a statistically significant and clinically meaningful improvement in MFS vs pbo + ADT. The safety profile of enza was consistent with results from previous clinical studies.
    P3 data • Journal
    |
    Xtandi (enzalutamide capsule) • Eligard (leuprolide acetate) • Lutrate (leuprorelin depot) • apatorsen (OGX-427) • custirsen (OGX-011)
    over1year
    Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study (clinicaltrials.gov)
    P3; Recruiting --> Active, not recruiting | N=810 --> 27
    Enrollment change • Enrollment closed • Surgery
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    Eligard (leuprolide acetate) • Nubeqa (darolutamide) • triptorelin • goserelin acetate • Viadur (leuprorelin implant)
    over1year
    ImmunoADAPT: Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov)
    P2, N=33, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    ER (Estrogen receptor)
    |
    ER positive
    |
    Ibrance (palbociclib) • tamoxifen • Bavencio (avelumab) • Eligard (leuprolide acetate) • goserelin acetate
    over1year
    OVELIA: Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer (clinicaltrials.gov)
    P3, N=250, Recruiting, Tolmar Inc. | Trial completion date: Jun 2024 --> Apr 2025 | Trial primary completion date: Jun 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    tamoxifen • letrozole • anastrozole • exemestane • Eligard (leuprolide acetate)
    2years
    A Phase 3 study evaluating ovarian suppression following three-month leuprolide acetate in combination with endocrine therapy in premenopausal subjects with HR+, HER2-negative breast cancer (OVELIA) (SABCS 2022)
    Eligible subjects will enter the 48 week Treatment Period in 2 groups: those receiving tamoxifen concurrently with TOL2506 or those who initiate therapy with an aromatase inhibitor (AI; letrozole, anastrozole, or exemestane) beginning 6 weeks after the first administration of TOL2506, if E2 < 20 pg/mL has been achieved. Secondary endpoints include suppression of LH, E2 (< 20 pg/mL for tamoxifen cohort and < 2.72 pg/mL for AI cohort) and absence of menses at weeks 6, 12, 24, 36, and 48. NCT04906395
    Clinical • P3 data • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    tamoxifen • letrozole • anastrozole • Eligard (leuprolide acetate)
    2years
    Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=70, Recruiting, City of Hope Medical Center | Active, not recruiting --> Recruiting | N=20 --> 70
    Enrollment open • Enrollment change
    |
    AR (Androgen receptor)
    |
    Talzenna (talazoparib) • abiraterone acetate • Eligard (leuprolide acetate) • bicalutamide • goserelin acetate • Firmagon (degarelix) • Viadur (leuprorelin implant) • Yonsa (abiraterone acetate)
    2years
    Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | N=70 --> 20
    Enrollment closed • Enrollment change
    |
    AR (Androgen receptor)
    |
    Talzenna (talazoparib) • abiraterone acetate • Eligard (leuprolide acetate) • bicalutamide • goserelin acetate • Firmagon (degarelix) • Viadur (leuprorelin implant) • Yonsa (abiraterone acetate)
    over2years
    A phase 3, single arm, open-label study evaluating ovarian suppression following 3-month leuprolide acetate for injectable suspension in combination with endocrine therapy in premenopausal subjects with HR+, HER2-negative breast cancer (OVELIA). (ASCO 2022)
    Eligible subjects will enter the 48 week treatment period in 2 groups: those receiving tamoxifen concurrently with TOL2506 or those who initiate therapy with an aromatase inhibitor (AI; letrozole, anastrozole, or exemestane) beginning 6 weeks after the first administration of TOL2506, if E2 < 20 pg/mL has been achieved. Achievement of ovarian suppression will be defined as ≥ 90% of subjects with luteinizing hormone (LH) levels < 4 IU/L at Week 6. Secondary endpoints include suppression of LH, E2 (< 20 pg/mL for tamoxifen cohort and < 2.72 pg/mL for AI cohort) and absence of menses at weeks 6, 12, 24, 36, and 48.
    Clinical • P3 data • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    tamoxifen • letrozole • anastrozole • exemestane • Eligard (leuprolide acetate)