Drugs / Leuprolide
Leuprolide
also known as
Leuprolide Acetate · Leuprorelin · Lupron · leuprorelin acetate · Eligard · Lupron Depot · Lucrin · CKD-841 · +26 more
Regulatory milestones approvals, filings & regulatory actions · 16 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed castration-resistant prostate carcinoma 1 milestone | |||||
| Filed | China (NMPA) | Camcevi | castration-resistant prostate carcinoma | 2025-02-20 | “the marketing application of its Leuprorelin Injection Emulsion ( Camcevi ) has been accepted by the National Medical Products Administration” genscigroup.com ↗ |
| Filed prostate cancer, hereditary, X-linked 3 1 milestone | |||||
| Filed | Japan (PMDA) | Leuplin | prostate cancer, hereditary, X-linked 3 | 2014-09-05 | “submitted a New Drug Application ("NDA") to the Japanese Ministry of Health, Labour and Welfare for "Leuplin ® " 6 month depot” takeda.com ↗ |
| Approved Indication not stated 7 milestones | |||||
| Label expansions (3) | US (FDA) | LUPRON DEPOT-PED KIT | — | 2011-08-15 – 2025-05-22 | fda.gov ↗ |
| Label expansion | US (FDA) | ELIGARD KIT | — | 2023-07-20 | fda.gov ↗ |
| Label expansion | US (FDA) | LEUPROLIDE ACETATE FOR DEPOT SUSPENSION | — | 2023-02-28 | fda.gov ↗ |
| Approved | EU (EMA) | Camcevi | — | 2022-05-24 | europa.eu ↗ |
| Label expansions (6) | US (FDA) | LUPRON DEPOT | — | 1997-05-30 – 2022-04-18 | fda.gov ↗ |
| Filed | Japan (PMDA) | — | — | 2005-02-28 | “Sosei submitted its application for the regulatory approval of Eligard as a generic product in February 2005 to the Japanese Ministry” nxera.life ↗ “a marketing authorisation application for SOT-375 (known as Eligard® in the US) has been submitted to the Japanese Ministry of Health” nxera.life ↗ |
| Approved | US (FDA) | LUPRON | — | 1985-04-09 | fda.gov ↗ |
Trials 216 · started per year
today
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EU approved 2022
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials · 1 met primary | ||||||
| Phase 0 | NCT03511196 | Sep 2018 → Jun 2022 overdue | prostate adenocarcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | Met primary |
| Phase 0 | NCT01422096 | Jun → Jul 2018 | obesity disorder, polycystic ovary syndrome | University of Virginia | Withdrawn | No outcome recorded |
| Phase 0 | NCT00734279 | Mar 2006 → Nov 2010 | delayed puberty, self-limited, precocious puberty | University of Utah | Completed | No outcome recorded |
| Phase 111 trials | ||||||
| Phase 1 | NCT04840745 | Apr → Oct 2021 | precocious puberty | Chong Kun Dang Pharmaceutical | Unknown | No outcome recorded |
| Phase 1 | NCT04783636 | Mar → Jul 2021 | prostate cancer | Peptron, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT04760691 | Mar 2021 → Mar 2025 | HIV infectious disease | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT03233932 | Apr 2016 → Jul 2017 | — | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT02448459 | May 2015 → Mar 2016 | infertility disorder | University of Sao Paulo | Completed | No outcome recorded |
| Phase 1 | NCT02023463 | Apr 2014 → Jul 2017 overdue | prostate adenocarcinoma | Thomas Jefferson University | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02064036 | Jun 2013 → Dec 2020 | prostate adenocarcinoma | University of California, Davis | Completed | No outcome recorded |
| Phase 1 | NCT01160328 | Jun 2010 → Jan 2013 | obesity disorder | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT00379626 | Aug 2003 → Aug 2008 | paraphilic disorder | Norwegian University of Science and Technology | Terminated | No outcome recorded |
| Phase 1 | NCT02911350 | May 2000 → Dec 2016 | prostate cancer | NYU Langone Health | Completed | No outcome recorded |
| Phase 1 | NCT00001259 | Aug 1992 → Feb 2020 | premenstrual tension | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 1/23 trials · 1 met primary | ||||||
| Phase 1/2 | NCT02990845 | Sep 2017 → Aug 2022 | breast carcinoma | National Taiwan University Hospital | Terminated | Met primary |
| Phase 1/2 | NCT00669162 | Aug 2012 → Aug 2016 | prostate cancer | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00653757 | Mar 2002 → Dec 2006 | prostate cancer | Mayo Clinic | Completed | No outcome recorded |
| Phase 293 trials · 4 met primary · 2 missed | ||||||
| Phase 2 | NCT07801898 | Sep 2026 → Sep 2028 expected | invasive breast carcinoma | The Second Hospital of Anhui Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07801664 | Aug 2026 → Aug 2028 expected | prostate cancer | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT07610733 | Jun 2026 → Sep 2027 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07027124 | May 2026 → Dec 2027 expected | prostate cancer | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 2 | NCT06654336 | May 2026 → Apr 2031 expected | prostate adenocarcinoma | Ontario Clinical Oncology Group (OCOG) | Recruiting | No outcome recorded |
| Phase 2 | NCT07455903 | Apr 2026 → Oct 2029 expected | prostate carcinoma | Baptist Health South Florida | Recruiting | No outcome recorded |
| Phase 2 | NCT07158021 | Jan 2026 → Jan 2028 expected | female breast carcinoma, invasive breast carcinoma | University of Michigan Rogel Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07313241 | Nov 2025 → Nov 2030 expected | prostate cancer | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07159451 | Oct 2025 → Jan 2027 expected | breast cancer | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 2 | NCT07179939 | Sep 2025 → Dec 2030 expected | HER2 positive breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06225284 | Aug 2024 → Dec 2026 expected | triple-negative breast carcinoma | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06330805 | Aug 2024 → Dec 2027 expected | prostate adenocarcinoma | Ohio State University Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06397703 | Apr 2024 → Apr 2030 expected | prostate cancer | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT06169124 | Feb 2024 → May 2027 expected | ovarian granulosa cell tumor | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05574712 | Jan 2024 → Jan 2025 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Withdrawn | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05924256 | Jul 2023 → Dec 2026 expected | salivary gland carcinoma | Fudan University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05669664 | Jul 2023 → Nov 2026 expected | salivary gland carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03845751 | Mar 2023 → Jul 2026 | prostate cancer | Institut Mutualiste Montsouris | Completed | No outcome recorded |
| Phase 2 | NCT05320406 | Jun 2022 → Jan 2025 overdue | prostate carcinoma | Emory University | Active not recruiting | Met primary |
| Phase 2 | NCT05478083 | Jun 2022 → Jun 2027 expected | autosomal dominant polycystic kidney disease, liver disorder | University Medical Center Groningen | Recruiting | No outcome recorded |
| Phase 2 | NCT05096065 | Mar → May 2022 | endometriosis | Enteris BioPharma Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT05100472 | Oct 2021 → Oct 2026 expected | prostate cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03902951 | Mar 2021 → Jan 2027 expected | prostate adenocarcinoma, prostate neuroendocrine neoplasm | Jonsson Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04569747 | Jan 2021 → Mar 2029 expected | HER2 positive breast carcinoma, hormone receptor-positive breast cancer, invasive breast carcinoma | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03649724 | Nov 2020 → Jul 2026 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 2 | NCT04585932 | Nov 2020 → Jan 2021 | metastatic prostate carcinoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT04051320 | Jan 2020 → Jul 2022 | postpartum depression | University of North Carolina, Chapel Hill | Completed | Missed primary |
| Phase 2 | NCT03900637 | Nov 2019 → Oct 2023 overdue | breast cancer | Seoul National University Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04249154 | Sep 2019 → Dec 2026 expected | prostate cancer | McGill University Health Centre/Research Institute of the McGill University Health Centre | Recruiting | No outcome recorded |
| Phase 2 | NCT03361735 | Aug 2018 → Mar 2024 overdue | prostate adenocarcinoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03541928 | Aug 2018 → Jul 2023 | prostate cancer | The Methodist Hospital Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT03298087 | Jul 2018 → Mar 2024 | — | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2 | NCT02972060 | Dec 2017 → Jan 2023 overdue | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03279250 | Oct 2017 → May 2021 | prostate adenocarcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02807363 | Aug 2017 → Jun 2018 | endometriosis | Enteris BioPharma Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03497702 | May 2017 → Nov 2023 | invasive breast carcinoma | National Cancer Center, Korea | Unknown | No outcome recorded |
| Phase 2 | NCT03043807 | Feb 2017 → Oct 2022 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT02903368 | Oct 2016 → Apr 2022 | prostate cancer | Dana-Farber Cancer Institute | Completed | Missed primary |
| Phase 2 | NCT02770391 | Oct 2016 → Apr 2020 | prostate cancer | Case Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02716974 | Jun 2016 → Apr 2022 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT02592746 | Jun 2016 → Jun 2021 | breast cancer | Samsung Medical Center | Unknown | Met primary |
| Phase 2 | NCT02772588 | May 2016 → Jan 2026 | prostate cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02778919 | May 2016 → Mar 2018 | endometriosis | Kissei Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02689921 | Apr 2016 → Dec 2018 | breast neoplasm | Midwestern Regional Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02508636 | Dec 2015 → Aug 2020 | lymph node cancer, prostate cancer | University of California, San Francisco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02229734 | Dec 2014 → Aug 2017 | prostate cancer | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
| Phase 2 | NCT02212197 | Sep 2014 → Nov 2015 | prostate cancer | Camurus AB | Completed | No outcome recorded |
| Phase 2 | NCT02274779 | Aug 2014 → Jul 2018 | prostate cancer | Institut Cancerologie de l'Ouest | Completed | No outcome recorded |
| Phase 2 | NCT02064582 | May 2014 → Jun 2018 | prostate cancer | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01989780 | Jan 2014 → Jun 2018 | breast cancer | Japan Breast Cancer Research Group | Completed | Met primary |
| Phase 2 | NCT03211052 | Feb 2013 → Jun 2015 | prostate cancer | Centre of Experimental Medicine | Terminated | No outcome recorded |
| Phase 2 | NCT01746849 | Dec 2012 → Dec 2026 expected | leukemia, myelodysplastic syndrome, non-Hodgkin lymphoma, plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01642186 | Jul 2012 → Jul 2021 | fibrolamellar hepatocellular carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01452685 | Mar 2012 → Dec 2013 | endometriosis | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT01458301 | Oct 2011 → Aug 2013 | endometriosis | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT01431391 | Sep 2011 → Dec 2014 | prostate adenocarcinoma | Dendreon | Completed | No outcome recorded |
| Phase 2 | NCT01343368 | Jul 2011 → Apr 2015 | Hodgkins lymphoma, acute myeloid leukemia, non-Hodgkin lymphoma, plasma cell myeloma | Masonic Cancer Center, University of Minnesota | Terminated | No outcome recorded |
| Phase 2 | NCT01377389 | Jun 2011 → Apr 2017 | prostate cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT01338987 | Apr 2011 → Dec 2017 | acute lymphoblastic leukemia, acute myeloid leukemia, chronic myeloid leukemia, chronic myelomonocytic leukemia +1 | National Cancer Institute (NCI) | Completed | Met primary |
| Phase 2 | NCT01023061 | Mar 2010 → Sep 2015 | prostate adenocarcinoma | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT00970203 | Sep 2009 → Oct 2018 | prostate cancer | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00937768 | Jul 2009 → Jun 2012 | prostate adenocarcinoma | Mayo Clinic | Terminated | No outcome recorded |
| Phase 2 | NCT00903162 | May 2009 → Jul 2014 | female breast carcinoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00860158 | Mar 2009 → Dec 2010 | prostate cancer | Noah Hahn, M.D. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00771017 | Jul 2008 → ? | prostate cancer | Eastern Cooperative Oncology Group | Withdrawn | No outcome recorded |
| Phase 2 | NCT00658697 | Jun 2008 → Sep 2014 | prostate cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00528866 | Apr 2008 → Dec 2013 | prostate cancer | Radiation Therapy Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00589472 | Nov 2007 → Jun 2010 | prostate adenocarcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00498901 | Feb → Dec 2007 | breast cancer | University of Washington | Terminated | No outcome recorded |
| Phase 2 | NCT00544830 | Jul 2006 → Mar 2011 overdue | prostate adenocarcinoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00776074 | Jun 2006 → Jul 2007 | leiomyoma | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00329043 | May 2006 → Dec 2027 expected | prostate cancer | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00275262 | Feb 2006 → Feb 2009 | Hodgkins lymphoma, mantle cell lymphoma, plasma cell myeloma | Abbott | Terminated | No outcome recorded |
| Phase 2 | NCT00254397 | Nov 2005 → Oct 2012 | melanoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00123110 | Jul 2005 → Dec 2011 | — | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT01076335 | May 2005 → Jun 2015 | prostate cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00103376 | Oct 2004 → Oct 2009 | prostate cancer | Medical University of South Carolina | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00076440 | Dec 2003 → Mar 2007 | Alzheimer disease | Voyager Pharmaceutical Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00587431 | Jul 2003 → Feb 2008 | prostate cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00063310 | Mar 2003 → Feb 2006 | Alzheimer disease | Voyager Pharmaceutical Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00429494 | Nov 2002 → Jun 2011 | amenorrhea, primary ovarian failure | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00028769 | Dec 2001 → Jun 2010 | prostate cancer | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 2 | NCT00586898 | Jul 2001 → Mar 2009 | cancer, prostate disorder | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00016913 | May 2001 → Jul 2007 | prostate cancer | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 2 | NCT00006359 | Sep 2000 → Oct 2007 | prostate cancer | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 2 | NCT00684905 | Apr 2000 → Oct 2005 | prostate cancer | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT00003124 | May 1997 → Jan 2007 | prostate cancer | Herbert Irving Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00223665 | Jan 1997 → Sep 2012 | prostate cancer | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT00817739 | Dec 1996 → Sep 2005 | prostate cancer | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00004763 | Jan 1993 → ? | — | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 2 | NCT00004771 | Oct 1992 → ? | amyotrophic lateral sclerosis, bulbospinal muscular atrophy | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 2 | NCT00004311 | Jul 1989 → Jan 1996 | acanthosis nigricans, polycystic ovary syndrome | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT02221999 | Sep 2013 → Jan 2019 overdue | breast mucinous carcinoma, inflammatory breast carcinoma, invasive tubular breast carcinoma | RenJi Hospital | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT01603420 | Jul 2012 → May 2014 | prostate cancer | Proton Collaborative Group | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT00220350 | Oct 2001 → Aug 2005 | pedophilia | Schober, Justine, M.D. | Unknown | No outcome recorded |
| Phase 352 trials · 8 met primary · 4 missed | ||||||
| Phase 3 | NCT06855589 | Mar 2025 → Mar 2033 expected | prostate adenocarcinoma | Charles LeMoyne Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06650579 | Jan 2025 → Jul 2029 expected | prostate carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 3 | NCT06449027 | Aug 2024 → Nov 2025 overdue | breast carcinoma | Changchun GeneScience Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06025409 | Aug 2023 → Feb 2025 | central precocious puberty | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 3 | NCT05493709 | Jun 2023 → Dec 2025 | central precocious puberty | Foresee Pharmaceuticals Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT05169112 | Mar 2023 → Nov 2026 expected | prostate cancer | Ottawa Hospital Research Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT06984159 | Jul 2022 → Nov 2023 | prostate cancer | Changchun GeneScience Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04914195 | Jul 2021 → Sep 2022 | prostate adenocarcinoma | Bharat Serums and Vaccines Limited | Completed | No outcome recorded |
| Phase 3 | NCT04302454 | Mar 2020 → Oct 2027 expected | prostate cancer | University Medical Center Groningen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03544073 | Apr 2019 → Jun 2020 | female infertility, male infertility | Maimonides Medical Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03695237 | Oct 2018 → May 2021 | central precocious puberty | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02736435 | Jan 2018 | uterine corpus leiomyoma | Thunder Bay Regional Health Research Institute | Withdrawn | No outcome recorded |
| Phase 3 | NCT03261999 | Sep 2017 → Nov 2018 | prostate neoplasm | Foresee Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02712320 | Feb 2016 → May 2017 | prostate neoplasm | Foresee Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02518191 | Sep 2015 → Jan 2021 | female breast carcinoma | Xiangyun Zong | Completed | Met primary |
| Phase 3 | NCT02344472 | Sep 2015 → Jan 2025 | breast cancer | University of Ulm | Unknown | No outcome recorded |
| Phase 3 | NCT02452931 | Aug 2015 → Sep 2018 | central precocious puberty | Tolmar Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02319837 | Dec 2014 → Jan 2023 overdue | prostate cancer | Pfizer | Active not recruiting | Met primary |
| Phase 3 | NCT02234115 | Aug 2014 → Aug 2016 | prostate carcinoma | Foresee Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02085252 | Jun 2013 → Nov 2016 | prostate cancer | Takeda | Completed | Met primary |
| Phase 3 | NCT02980965 | May 2013 → Feb 2017 | female breast carcinoma | Fudan University | Completed | No outcome recorded |
| Phase 3 | NCT01638247 | Aug 2012 → May 2018 | male breast carcinoma | GBG Forschungs GmbH | Completed | No outcome recorded |
| Phase 3 | NCT01546623 | Mar 2012 → Apr 2014 | prostate cancer | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01492972 | Jan 2012 → Dec 2027 expected | prostate cancer | Proton Collaborative Group | Recruiting | No outcome recorded |
| Phase 3 | NCT01415960 | Sep 2011 → May 2013 | prostate cancer | GP-Pharm | Completed | No outcome recorded |
| Phase 3 | NCT01442246 | Jul 2011 → Sep 2027 expected | metastatic neoplasm | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01368588 | Jul 2011 → Apr 2025 overdue | prostate cancer | Radiation Therapy Oncology Group | Active not recruiting | Missed primary |
| Phase 3 | NCT00949962 | Oct 2009 → Dec 2015 | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00936390 | Sep 2009 → Oct 2020 | prostate cancer | Radiation Therapy Oncology Group | Completed | Missed primary |
| Phase 3 | NCT00667446 | Dec 2008 → Oct 2012 | central precocious puberty | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT00635817 | Jun 2008 → Jan 2010 | central precocious puberty | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00687739 | May 2008 → Jun 2014 | obesity disorder | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 3 | NCT00630799 | May 2008 → Apr 2009 | prostate cancer | GP-Pharm | Terminated | No outcome recorded |
| Phase 3 | NCT00626431 | Feb 2008 → Aug 2009 | prostate cancer | Abbott | Completed | Met primary |
| Phase 3 | NCT00567580 | Feb 2008 → Jul 2018 | prostate cancer | Radiation Therapy Oncology Group | Unknown | Met primary |
| Phase 3 | NCT00601276 | Dec 2007 → Jun 2009 | pedophilia | French National Institute of Health and Medical Research | Terminated | No outcome recorded |
| Phase 3 | NCT00541047 | Nov 2007 → Jul 2022 | prostate cancer, sexual disorder | University College, London | Completed | Mixed |
| Phase 3 | NCT00430183 | May 2007 → Oct 2018 overdue | prostate cancer | Alliance for Clinical Trials in Oncology | Active not recruiting | Missed primary |
| Phase 3 | NCT00598312 | Apr 2007 → Aug 2008 | prostate cancer | Oakwood Laboratories, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00355030 | Jun 2006 → Jul 2015 | isolated short stature | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00378690 | Mar 2006 → Jun 2011 | prostate cancer | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00128531 | Sep 2005 → Nov 2007 | prostate cancer | GP-Pharm | Completed | Met primary |
| Phase 3 | NCT00229996 | Jul 2004 → ? | endometriosis, pelvis syndrome | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 3 | NCT00076531 | Dec 2003 → Nov 2004 | prostate cancer | Oakwood Laboratories, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00193856 | Oct 2003 → Aug 2017 | prostate cancer | Trans Tasman Radiation Oncology Group | Completed | Mixed |
| Phase 3 | NCT00005044 | Feb 2000 → Sep 2012 | prostate cancer | Radiation Therapy Oncology Group | Completed | Missed primary |
| Phase 3 | NCT00003645 | Jun 1999 → Mar 2017 | prostate cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 3 | NCT00002881 | Oct 1996 → Apr 1998 | prostate cancer | Eastern Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00002597 | Oct 1994 → Jul 2011 | prostate cancer | Radiation Therapy Oncology Group | Completed | Met primary |
| Phase 3 | NCT00002580 | Jun 1993 → ? | breast cancer | Scottish Cancer Therapy Network | Completed | No outcome recorded |
| Phase 3 | NCT00002582 | Jun 1993 → Apr 2007 | breast cancer | Institute of Cancer Research, United Kingdom | Completed | No outcome recorded |
| Phase 3 | NCT00660010 | Jan 1991 → Apr 2009 | central precocious puberty | Abbott | Completed | No outcome recorded |
| Phase 431 trials · 1 missed | ||||||
| Phase 4 | NCT07710430 | Aug 2026 → Aug 2029 expected | central precocious puberty | LG Chem | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06627530 | Feb 2025 → Mar 2026 overdue | prostate cancer | Brazilian Clinical Research Institute | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06926933 | Dec 2024 → Jun 2026 overdue | — | HanAll BioPharma Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05937490 | Mar 2023 → Mar 2025 | adenomyosis | University Hospital of Modena | Unknown | No outcome recorded |
| Phase 4 | NCT05341115 | Mar 2023 → Dec 2024 | central precocious puberty | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT05333328 | Feb 2023 → Jan 2031 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | Gangnam Severance Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT03946722 | Aug 2020 → Aug 2023 | adenomyosis | University College, London | Unknown | No outcome recorded |
| Phase 4 | NCT04248621 | Jan 2020 → Apr 2022 | prostate neoplasm | Wonju Severance Christian Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05304169 | Nov 2017 → Jun 2018 | prostate cancer | Zodiac Produtos Farmaceuticos S.A. | Completed | No outcome recorded |
| Phase 4 | NCT03047330 | Jul 2017 → Aug 2022 | — | Brigham and Women's Hospital | Completed | Mixed |
| Phase 4 | NCT03035032 | Jun 2017 → Nov 2019 | prostate cancer | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT02974270 | Jun 2016 → Mar 2018 | central precocious puberty | Kyungpook National University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02715336 | Oct 2015 → Sep 2020 | habitual spontaneous abortion, ovarian hyperstimulation syndrome, pregnancy disorder | Create Fertility Center | Unknown | No outcome recorded |
| Phase 4 | NCT02427958 | Aug 2015 → Nov 2018 | central precocious puberty | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT03316482 | Jun 2015 → Aug 2019 | central precocious puberty | Jin Soon Hwang | Completed | No outcome recorded |
| Phase 4 | NCT01933022 | Aug 2014 → Aug 2015 | metastatic prostate carcinoma | Astellas Pharma Europe Ltd. | Terminated | No outcome recorded |
| Phase 4 | NCT01948804 | Jan → Mar 2014 | — | Pınar Özcan Cenksoy | Unknown | No outcome recorded |
| Phase 4 | NCT01443546 | Jan 2013 → Jun 2016 | infertility disorder | Weill Medical College of Cornell University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02920515 | Sep 2012 → Aug 2015 | central precocious puberty | Ruijin Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01606709 | Apr 2012 → Dec 2014 | ovarian hyperstimulation syndrome | UConn Health | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01634321 | Jul 2011 → Aug 2012 | central precocious puberty | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 4 | NCT01511874 | Jan 2011 → May 2013 | prostate cancer | HanAll BioPharma Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT01116401 | Nov 2009 → Dec 2011 | depressive disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00826839 | Jan 2009 → Sep 2010 | infertility disorder | Weill Medical College of Cornell University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00455689 | Nov 2005 → Jul 2007 | — | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00349258 | Aug 2004 → May 2006 | ovarian hyperstimulation syndrome | University of Connecticut | Completed | No outcome recorded |
| Phase 4 | NCT00206375 | May 2003 → Sep 2011 | hypothyroidism | Baylor College of Medicine | Terminated | No outcome recorded |
| Phase 4 | NCT00220194 | Apr 2003 → Jun 2005 | prostate cancer | San Bernardino Urological Associates Medical Group Inc | Completed | No outcome recorded |
| Phase 4 | NCT00621179 | Mar 2003 → Aug 2009 | endometriosis, infertility disorder | Colorado Center for Reproductive Medicine | Completed | Missed primary |
| Phase 4 | NCT00438217 | — | central precocious puberty | University of Pisa | Unknown | No outcome recorded |
| Phase 4 | NCT00505817 | — | — | Instituto Valenciano de Infertilidad, IVI VALENCIA | Completed | No outcome recorded |
| Phase not applicable20 trials · 2 missed | ||||||
| — | NCT07444983 | Feb 2026 → Feb 2027 expected | prostate adenocarcinoma | Fujian Medical University Union Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06512207 | Dec 2023 → Dec 2025 overdue | non-small cell lung carcinoma | Jinzhou Medical University | Recruiting | No outcome recorded |
| — | NCT05206682 | May 2023 → Apr 2027 expected | — | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | No outcome recorded |
| — | NCT05667428 | Mar 2023 → Oct 2025 | disease related to hematopoietic stem cell transplant, primary ovarian failure | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| — | NCT04192812 | Dec 2020 → Dec 2021 | central precocious puberty, leiomyoma | Alkü Alanya Education and Research Hospital | Unknown | No outcome recorded |
| — | NCT02927392 | Mar 2017 → May 2023 | obesity disorder | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT05945407 | Aug 2016 → Dec 2023 overdue | endometrial cancer, endometrial endometrioid adenocarcinoma | Peking University People's Hospital | Recruiting | No outcome recorded |
| — | NCT02238431 | Dec 2014 → May 2016 | pregnancy disorder | Antalya IVF | Withdrawn | No outcome recorded |
| — | NCT02114645 | Apr 2014 → Feb 2015 | infertility disorder | Zekai Tahir Burak Women's Health Research and Education Hospital | Unknown | No outcome recorded |
| — | NCT01762943 | Aug 2013 → Oct 2016 | postpartum depression | University of North Carolina, Chapel Hill | Completed | Missed primary |
| — | NCT01846728 | Apr 2013 → Oct 2015 | obesity disorder | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT01712230 | Oct 2012 → Oct 2017 | obesity disorder | University of Colorado, Denver | Completed | Missed primary |
| — | NCT01546454 | Feb → Jun 2012 | coronary artery disorder | Oregon Health and Science University | Completed | No outcome recorded |
| — | NCT01344564 | Apr 2011 → Aug 2012 | prostate cancer | Urology of Virginia | Completed | No outcome recorded |
| — | NCT00696111 | Dec 2007 → Jun 2022 | obstructive sleep apnea syndrome, polycystic ovary syndrome | University of Chicago | Completed | No outcome recorded |
| — | NCT00175383 | Jun 2004 → Feb 2008 | prostate cancer | University of British Columbia | Completed | No outcome recorded |
| — | NCT00056654 | Mar 2003 → Jul 2004 | prostate neoplasm | Abbott | Completed | No outcome recorded |
| — | NCT00004438 | Sep 1997 → Sep 2002 | hypogonadism | University of Chicago | Completed | No outcome recorded |
| — | NCT00004426 | Aug 1994 → Sep 1998 | hypogonadism | University of Chicago | Completed | No outcome recorded |
| — | NCT00004436 | Jul 1993 → Jun 2000 | hemangioma | FDA Office of Orphan Products Development | Completed | No outcome recorded |
| Comparator or background therapy200 trials | ||||||
| Phase 0 | NCT07389187 Background | Feb → Dec 2026 expected | castration-resistant prostate carcinoma | Shanghai Changzheng Hospital | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT07389174 Background | Feb 2026 → Jan 2027 expected | prostate adenocarcinoma | Shanghai Changzheng Hospital | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT04445025 Comparator | Sep 2020 → Sep 2024 | endometriosis, infertility disorder | Colorado Center for Reproductive Medicine | Completed | No outcome recorded |
| Phase 0 | NCT01763541 Background | Jun 2014 → Feb 2016 | hypertensive disorder | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 1 | NCT07755956 Comparator | Aug 2026 → Mar 2027 expected | endometriosis | Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd. | Recruiting | No outcome recorded |
| Show all 200 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 27
| Date | Issuer | Release |
|---|---|---|
| 2026-10-10 | Changchun GeneScience Pharmaceutical Co., Ltd. | Regulatory GenSci's Oncology Innovation: NDA Approval Secured for Prostate Cancer genscigroup.com ↗
GenSci's Leuprorelin Mesylate Injection (6M) has recently received NDA approval from the National Medical Products Administration(NMPA) for the treatment of advanced prostate cancer in patients requiring androgen deprivation therapy(ADT). |
| 2026-05-27 | Foresee Pharmaceuticals Co., Ltd. | Results Foresee Pharmaceuticals Announces Completion of Casppian Phase 3 Study with Last Patient Last Visit and Confirms Topline Results: 94% of Patients Achieve LH Suppression with 6-Month Dosing Interval of Leuprolide Mesylate foreseepharma.com ↗ |
| 2026-02-04 | Foresee Pharmaceuticals Co., Ltd. | Results Foresee Pharmaceuticals Receives the Fourth Positive Recommendation from the DSMB to Continue the Casppian Ph3 Study, for Central Precocious Puberty (CPP) foreseepharma.com ↗
The DSMB recommended that Foresee Pharmaceuticals continue the trial as planned without any modification. |
| 2025-12-24 | Foresee Pharmaceuticals Co., Ltd. | Results Foresee Pharmaceuticals announces the Casppian Phase 3 Study Meets Primary Efficacy Endpoint, Demonstrating Robust LH Suppression with 6-Month Dosing Interval of leuprolide mesylate foreseepharma.com ↗ |
| 2025-11-14 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from USFDA for Leuprolide Acetate Injection zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Leuprolide Acetate injection, 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial (USRLD: Lupron Injection®, 1 mg/0.2 mL). |
| 2025-10-19 | Pfizer | Results XTANDI® Plus Leuprolide Reduced Risk of Death by 40% vs Leuprolide Alone in Men with a Type of Advanced Prostate Cancer pfizer.com ↗
The probability of survival at 8 years was an unprecedented 78.9% with XTANDI plus leuprolide versus 69.5% with leuprolide, in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence |
| 2025-08-29 | Foresee Pharmaceuticals Co., Ltd. | Regulatory Foresee Pharmaceuticals Announces FDA Approval of CAMCEVI ETM for the Treatment of Advanced Prostate Cancer foreseepharma.com ↗
announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI ETM |
| 2025-07-10 | Pfizer | Results XTANDI® Plus Leuprolide Significantly Improves Survival Outcomes in Men with Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence pfizer.com ↗
For patients treated with XTANDI plus leuprolide versus placebo plus leuprolide, EMBARK met the key secondary endpoint with a statistically significant and clinically meaningful improvement in OS. |
| 2025-02-20 | Changchun GeneScience Pharmaceutical Co., Ltd. | Regulatory GenSci Submits Another Blockbuster Product for Market Approval genscigroup.com ↗
Recently, GenSci announced that the marketing application of its Leuprorelin Injection Emulsion ( Camcevi ) has been accepted by the National Medical Products Administration ( NMPA ), and it is intended for Androgen Deprivation Therapy ( ADT ) of advanced prostate cancer. |
| 2025-01-13 | Foresee Pharmaceuticals Co., Ltd. | Regulatory Foresee Pharmaceuticals Announces the PDUFA Goal Date for the 3-month Version of CAMCEVI is August 29, 2025 foreseepharma.com ↗
Foresee Pharmaceuticals (TPEx: 6576), (“Foresee”) announces that the U.S. Food and Drug Administration (FDA) issued a Day-74 letter. |
| 2024-10-30 | Foresee Pharmaceuticals Co., Ltd. | Regulatory Foresee Pharmaceuticals Announces Submission of the NDA to the U.S. FDA for the 3-month Version of CAMCEVI for the Treatment of Advanced Prostate Cancer foreseepharma.com ↗
Foresee Pharmaceuticals Co., Ltd. (TPEx: 6576), (“Foresee”) announced today that it has submitted a 505(b)(2) New Drug Application for the 3-month version of CAMCEVI, a ready-to-use 3-month depot formulation of leuprolide mesylate, to the U.S. Food and Drug Administration (FDA). |
| 2024-09-11 | Astellas Pharma Inc | Results Astellas Presents Scientific Progress in Advanced and Hard-to-Treat Cancers at ESMO 2024 astellas.com ↗
These results support the benefits of enzalutamide both in combination with leuprolide and as monotherapy in patients aged <70 and ≥70 years. |
| 2024-04-01 | Foresee Pharmaceuticals Co., Ltd. | Results Foresee Pharmaceuticals Receives Positive Recommendation from DSMB to Continue the Casppian Study, a Phase 3 Clinical Trial of Leuprolide (FP-001) Injectable Emulsion for the Treatment of CPP foreseepharma.com ↗
There has been no safety concern with the use of Leuprolide (FP-001) injectable Emulsion in pediatric CPP patients. |
| 2023-04-29 | Pfizer | Results XTANDI® (enzalutamide) plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide pfizer.com ↗ |
| 2023-04-29 | Astellas Pharma Inc | Results XTANDI ® (enzalutamide) plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide astellas.com ↗ |
| 2023-03-17 | Astellas Pharma Inc | Results Phase 3 Study Shows XTANDI ® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer astellas.com ↗
The study met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide versus placebo plus leuprolide. |
| 2023-03-16 | Pfizer | Results Phase 3 Study Shows XTANDI® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer pfizer.com ↗
The study met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide versus placebo plus leuprolide. |
| 2022-05-31 | Foresee Pharmaceuticals Co., Ltd. | Regulatory Foresee Pharmaceuticals Announces European Commission Approval of CAMCEVI® for the Treatment of Advanced Prostate Cancer; Accord Healthcare to Head the E.U. Commercialization foreseepharma.com ↗
We are very pleased CAMCEVI 42 mg has been approved in the EU. |
| 2020-05-18 | Tolmar Inc. | Results Real-World Data Analysis Published in the Journal of Urology Explores Frequency of Late Luteinizing Hormone-Releasing Hormone Agonist (LHRH) Dosing and Impact on Testosterone Suppression in Patients with Prostate Cancer tolmar.com ↗
84% of injections were administered late with a 28-day month schedule, with 60% more than one week late and 29% more than two weeks late. |
| 2017-05-14 | Tolmar Inc. | Results Data From Tolmar Pharmaceuticals on ELIGARD Demonstrate Serum Leuprolide Levels Required to Maintain Stable, Long-Term Testosterone Suppression Across All Doses Serum Level of Leuprolide Acetate Required to Maintain Low T Established tolmar.com ↗
Tolmar Pharmaceuticals, Inc. announced today that clinical data from four pivotal trials demonstrate that ELIGARD® (leuprolide acetate for injectable suspension) maintains stable, long-term testosterone (T) suppression. |
| 2016-06-21 | Camurus AB | Results Camurus announces results from a Phase 2 trial of CAM2032 in patients with prostate cancer camurus.com ↗
Camurus today announces positive results from a repeat-dose Phase 2 trial of two dose levels of leuprolide FluidCrystal® injection depot (CAM2032 3.75 mg and 7.5 mg) and the active comparator, Eligard® 7.5 mg, in patients with prostate cancer. |
| 2016-05-06 | Tolmar Inc. | Regulatory Tolmar Pharmaceuticals Announces That FDA Approval Has Been Received For ELIGARD® (leuprolide acetate for injectable suspension) Storage at Room Temperature For up to 8 Weeks tolmar.com ↗
Tolmar Pharmaceuticals, Inc., today announced that approval has been received from FDA for a label update for ELIGARD®, indicated for the palliative treatment of advanced prostate cancer. |
| 2015-09-28 | Takeda | Regulatory Takeda Obtained New Drug Application Approval of "Leuplin ® PRO for injection kit 22.5 mg" in Japan for the Treatment of Prostate Cancer and Premenopausal Breast Cancer takeda.com ↗
Leuplin PRO becomes the world's first product to obtain approval for the treatment of premenopausal breast cancer for 24 week depot. |
| 2015-05-18 | Tolmar Inc. | Results Data From Tolmar Pharmaceuticals Demonstrate ELIGARD® (leuprolide acetate for injectable suspension) Consistently Suppresses Serum Testosterone Levels in Patients With Advanced Prostate Cancer tolmar.com ↗
Tolmar Pharmaceuticals, Inc. presented data demonstrating that ELIGARD® (leuprolide acetate for injectable suspension), indicated for the palliative treatment of advanced prostate cancer, consistently maintains low serum testosterone (T) levels. |
| 2014-09-05 | Takeda | Regulatory Takeda Submits a New Drug Application for Leuplin ® 6 Month Depot in Japan for the Treatment of Prostate Cancer and Premenopausal Breast Cancer takeda.com ↗
6M depot becomes the world's first submission for the treatment of premenopausal breast cancer. |
| 2007-01-16 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical Reports Phase IV Clinical Trials of Prostate Cancer Treatment Drug (GnRH Agonist) Luphere® daewoong.co.kr ↗
In the phase IV clinical trials, testosterone, which stimulates prostate cancer cell growth have dropped to lower than castrate levels (50ng/dL) in 97% of all patients after 12 weeks of Luphere® Depot Injections. |
| 2005-02-28 | Nxera Pharma UK Limited | Regulatory Sosei Files Marketing Authorisation Application for SOT-375 nxera.life ↗
announced today that a marketing authorisation application for SOT-375 (known as Eligard® in the US) has been submitted to the Japanese Ministry of Health, Labour and Welfare (MHLW) requesting approval for marketing in Japan. |
All press releases naming this drug 40 releases
Evidence & citations 38 cited values
Every value below carries the sentence it was read from. 419 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Leuprolide | “All patients receive neoadjuvant androgen-deprivation therapy comprising bicalutamide orally (PO) once daily or flutamide PO thrice daily for 4-6 months, and luteinizing...” NCT01368588 ↗165“Participants will be administered with LHRHa (example, leuprolide, goserelin, triptorelin acetate) as a 3-monthly depot preparation within 3 days after randomization and the...” NCT04557059 ↗ “LHRH analogue (either leuprolide or goserelin): Leuprolide is an intramuscular injection, and goserelin subcutaneous (under skin) of abdomen, given either 1 injection every 3...” NCT01088529 ↗ “one injection of open-label intramuscular dose of leuprolide (3.75-mg depot), a gonadotropin-releasing hormone agonist that rapidly suppresses estradiol and temporarily...” NCT03047330 ↗ “standard treatment with abiraterone acetate, prednisone, and Lupron® (leuprolide) is a safe and effective way to treat previously untreated metastatic prostate cancer” NCT04262154 ↗ “Leuprolide (3.75mg) will be given intramuscularly (in the buttock, thigh, or upper arm) on Day 1 of each cycle x 4 cycles. (Other Names: Leuprorelin, Lupron, Eligard)” NCT03573648 ↗ “All patients will receive luteinizing hormone-releasing hormone (LHRH) agonist therapy (leuprolide or goserelin acetate) concurrent with Cabazitaxel, before surgery.” NCT01531205 ↗ “1-month GnRH (goserelin 3.6 mg depot or goserelin 3.6 mg implant or leuprolide 3.75 mg depot) +endocrine therapy (aromatase inhibitor/tamoxifen±CDK4/6 inhibition)” NCT07610733 ↗ “we propose a randomized clinical trial using one versus three-month Leuprolide preparations in patients otherwise suitable for our Brachytherapy Program.” NCT00175383 ↗ “Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.” NCT01603420 ↗ “ADT will be delivered with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions.” NCT07801664 ↗ |
| Known as | CAMCEVI | “Leuprolide Injectable Emulsion (CAMCEVI®)” NCT06984159 ↗ |
| Known as | CKD-841 | “CKD-841(=leuprorelin acetate 3.75mg)” NCT03233932 ↗ |
| Known as | CKD-841 A-1 | “CKD-841 A-1(=leuprorelin acetate 3.75mg)” NCT04840745 ↗ |
| Known as | CKD-841 D | “CKD-841 D(=leuprorelin acetate 2.92mg)” NCT04840745 ↗ |
| Known as | Daronda depot | “The first group (Group A) was consisted of 60 women who received a depot preparation of a GnRH-a, 3.75 mg s.c, (leuprolide, Daronda depot, 3.75, Abbott, Hellas) every 28 days...” NCT01269125 ↗ |
| Known as | DWJ108J | “This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty.” NCT06025409 ↗ |
| Known as | Eligard | “To this day, the standard curative treatment for high risk prostate cancer patients is external beam radiation therapy (EBRT) combined with hormonal manipulation (Luteinizing...” NCT02303327 ↗18“The LUCINDA Trial is a three-site, phase II, randomized, double-blind, placebo-controlled study of leuprolide acetate (Eligard) in women with Mild Cognitive Impairment or...” NCT03649724 ↗ “Patients will continue on ADT with LHRH agonist (i.e. Zoladex, Trelstar, Eligard, or Lupron) or LHRH antagonist (Degarelix or Relugolix) if not surgically castrated throughout...” NCT06922318 ↗ “Patients received two subcutaneous injections of Eligard® 45 mg (leuprorelin acetate), with the first injection given at baseline (Visit 1) and the second after 168 ± 3 days at Visit 4.” NCT05304169 ↗ “Choice of LHRHa per investigator discretion/site practice guidelines (e.g, Eligard®, Zoladex®, Lupron Depot®, Trelstar®) and ARN-509 Tablets, 240 mg/day administered orally” NCT01790126 ↗ “luteinizing hormone-releasing hormone (LHRH) agonist (i.e. Zoladex, Trelstar, Eligard, or Lupron) or LHRH antagonist (Degarelix or Relugolix)” NCT06059118 ↗ “Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area.” NCT01161563 ↗ “LHRH agonist or antagonist (e.g. Eligard, Zoladex, Lupron, Orgovyx)” NCT07142551 ↗ “Leuprolide acetate ( ELIGARD®) Hormonal Therapy” NCT00283062 ↗ “Leuprolide Acetate (Eligard®)” NCT00452556 ↗ “Eligard™” NCT03809000 ↗ |
| Known as | Enantone | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05937490 ↗ |
| Known as | LAD | “Leuprolide acetate depot (LAD) 11.25 mg 3 Month” NCT00275262 ↗ |
| Known as | LEUP | “luteinizing hormone-releasing hormone (LHRH) analog (buserelin [BSRL], goserelin [ZDX], or leuprolide [LEUP])” NCT00003653 ↗ |
| Known as | Leuplin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03664895 ↗ |
| Known as | Leuplin DPS | “Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty” NCT03316482 ↗ |
| Known as | Leuplin Inj. | “Leuplin Inj.(=leuprorelin acetate 3.75mg)” NCT04840745 ↗ |
| Known as | LeuplinⓡInj | “LeuplinⓡInj(=leuprorelin acetate 3.75mg)” NCT03233932 ↗ |
| Known as | Leuporelin | “Leuporelin” NCT01978873 ↗ |
| Known as | Leuprolide Acetate | “Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix...” NCT03311555 ↗153“Patients receive multitargeted tyrosine kinase inhibitor PLX3397 orally (PO) twice daily (BID) for 6 months, undergo radiation therapy for 2 months daily (Monday-Friday)...” NCT02472275 ↗ “All subjects will receive androgen deprivation therapy with a LHRH agonist (any LHRH agonist such as leuprolide acetate or goserelin acetate is acceptable) or a LHRH antagonist...” NCT02582749 ↗ “PURPOSE: This clinical trial investigated the effectiveness, pharmacokinetic properties, and safety profile of leuprolide acetate 22.5-mg depot, a new 3-month leuprolide depot...” PMID 30929678 ↗ Feb 2019 “The purpose of the study is to demonstrate the safety and efficacy of Leuprolide Acetate for Injectable Suspension 22.5 mg in reducing serum testosterone to castrate levels in...” NCT00598312 ↗ “A GnRH analog (goserelin acetate, leuprolide acetate) will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and...” NCT00099086 ↗ “The LHRH agonist (leuprolide acetate, goserelin acetate, or triptorelin pamoate) will be administered by injection once every 4 weeks on Day 1 of each 28-day cycle, according...” NCT03332797 ↗ “These dosages are as follows: leuprolide acetate 22.5 mg depot injection x one dose, abiraterone acetate 1000 mg by mouth daily, and belzutifan120 mg administered by mouth once daily.” NCT05574712 ↗ “either goserelin acetate at 3.6 mg subcutaneously or leuprolide acetate at 7.5 mg intramuscularly monthly for 6 months starting at Day 1 of therapy.” NCT00016913 ↗ “Leuprolide Acetate is currently used in adults for prostate cancer, endometriosis, uterine fibroids and in preparation for in-vitro fertilization” NCT03649724 ↗ “luteinizing hormone-releasing hormone (LHRH) agonists including leuprolide acetate and goserelin acetate as per Investigator's discretion.” NCT02217566 ↗ |
| Known as | Leuprolide acetate ( Lupron) | “Leuprolide acetate ( Lupron)” NCT03683043 ↗1“leuprolide acetate (Lupron®)” NCT01531205 ↗ |
| Known as | Leuprolide Acetate (delayed release) | “Leuprolide Acetate (delayed release)” NCT00429494 ↗ |
| Known as | Leuprolide Injectable Emulsion | “Leuprolide Injectable Emulsion (CAMCEVI®)” NCT06984159 ↗ |
| Known as | Leuprorelin | “The primary objective of this study is to examine, in healthy subjects, the comparative pharmacodynamics of Lorelin Depot (leuprorelin), manufactured by the Chemical...” NCT01071005 ↗56“According to the standard treatment protocol, all participants will receive androgen deprivation therapy as leuprorelin, subcutaneous injections at three months intervals for a...” NCT06271551 ↗ “Baseline scan on day 1-5 of bleed and administer GnRH analogue (Leuprorelin acetate 3.75 mg subcutaneously single injection). 28 days later administer second dose of GnRH...” NCT03946722 ↗ “This regimen consists of Androgen Deprivation Therapy (ADT) (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix) combined with an oral Androgen Receptor (AR) inhibitor...” NCT07389174 ↗ “In patients randomized to receive GnRHa, 3.6 mg of goserelin or 3.75 mg of leuprorelin was injected subcutaneously once every 28 days from 1 to 2 weeks before the first cycle...” PMID 34967844 ↗ Feb 2022 “Pre- and peri-menopausal women will be receiving Ovarian Function Suppression (OFS) by either leuprorelin subcutaneous 3.75 mg q28days or goserelin subcutaneous 3.6 mg q28days...” NCT03969121 ↗ “In the first part of study we are studying changes in the offenders cognitive distortions and in the second part we are studying changes in sexual activities and sexual...” NCT00379626 ↗ “AHT group receives 9 cycle of LHRH-A (goserelin acetate 3.6 mg/4 weeks or leuprorelin acetate 3.75 mg/4 weeks) after Iodine I-125 implantation (TPPB).” NCT00664456 ↗ “This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty.” NCT06025409 ↗ “gonadotropin-releasing hormone agonist ("Leuprorelin", "Goserelin" or "Triptorelin") 3.75mg/28d injection subcutaneously” NCT05945407 ↗ “Leuprolide Acetate/ Leuprorelin is a depot injection administered as a subcutaneous injection once every month.” NCT04914195 ↗ |
| Known as | leuprorelin acetate | “Baseline scan on day 1-5 of bleed and administer GnRH analogue (Leuprorelin acetate 3.75 mg subcutaneously single injection). 28 days later administer second dose of GnRH...” NCT03946722 ↗27“Randomized Clinical Trial of the Pharmacodynamics of Lorelin Depot 3.75Mg (Leuprorelin Acetate) Produced by Laboratório Químico Farmacêutico Bergamo LTDA. Compared to Lupron...” NCT01071005 ↗ “Premenopausal patients also received ovarian function suppression with leuprorelin acetate (3.75 mg) subcutaneously every 28 days, from the start of neoadjuvant treatment until...” NCT07801898 ↗ “This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty.” NCT06025409 ↗ “After a single administration of PT105R (leuprorelin acetate 3.75mg), a single administration of PT105 (leuprorelin acetate 3.75mg)” NCT04783636 ↗ “ELIGARD® is a formulation of leuprorelin acetate whose safety and efficacy have been well-established in Western regions.” PMID 35280654 ↗ Feb 2022 “LH-RH analogue (LH-RHa) (Leuprorelin acetate 22.5 mg) will be delivered as a depot injection every 3 months.” NCT00193856 ↗ “TAK-700 for 6 months 300mg BD with Leuprorelin Acetate Injections prior to planned prostatectomy” NCT03211052 ↗ “Leuprorelin Acetate 45Mg Powder for Injection Suspension Vial” NCT03899077 ↗ “LeuplinⓡInj(=leuprorelin acetate 3.75mg)” NCT03233932 ↗ “CKD-841 A-1(=leuprorelin acetate 3.75mg)” NCT04840745 ↗ |
| Known as | Lorelin Depot | “The primary objective of this study is to examine, in healthy subjects, the comparative pharmacodynamics of Lorelin Depot (leuprorelin), manufactured by the Chemical...” NCT01071005 ↗1“Leuprolide(Lorelin Depot)” NCT02344550 ↗ |
| Known as | Lucrin | “This is a Randomized, Active Controlled, Comparative, Open-Label, Multi-Center, Phase 3 clinical study to compare the efficacy, safety, and pharmacokinetics of leuprolide...” NCT04914195 ↗3“This group of candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) followed by Letroloze 10mg OD for 3 months” NCT05437471 ↗ |
| Known as | Luphere depot | “Luphere depot 3.75mg(Leuprolide acetate 3.75mg)” NCT01634321 ↗ |
| Known as | Luprodex | “This is a Randomized, Active Controlled, Comparative, Open-Label, Multi-Center, Phase 3 clinical study to compare the efficacy, safety, and pharmacokinetics of leuprolide...” NCT04914195 ↗ |
| Known as | Lupron | “Patients will continue on ADT with LHRH agonist (i.e. Zoladex, Trelstar, Eligard, or Lupron) or LHRH antagonist (Degarelix or Relugolix) if not surgically castrated throughout...” NCT06922318 ↗32“The goal of this clinical research study is to learn how ipilimumab in combination with Lupron (leuprolide acetate) affects the body's own defense (immune) system before having...” NCT01194271 ↗ “standard treatment with abiraterone acetate, prednisone, and Lupron® (leuprolide) is a safe and effective way to treat previously untreated metastatic prostate cancer” NCT04262154 ↗ “luteinizing hormone-releasing hormone (LHRH) agonist (i.e. Zoladex, Trelstar, Eligard, or Lupron) or LHRH antagonist (Degarelix or Relugolix)” NCT06059118 ↗ “Drug: leuprolide acetate Other Names: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months” NCT01712230 ↗ “Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to be an effective treatment for PMS.” NCT00001259 ↗ “Estrogen production will be suppressed for 3 months by administering a drug, lupron, that suppresses ovarian function” NCT01846728 ↗ “Ovarian suppression was induced for 6 months with gonadotropin-releasing hormone (GnRH)-agonist (Lupron)” PMID 28786978 ↗ Aug 2017 “monthly injections of a luteinizing hormone-releasing hormone (LHRH) analog such as Lupron or Zoladex” NCT00283803 ↗ “participants will then be intramuscularly administered depot leuprolide acetate (11.25 mg Lupron®).” NCT04760691 ↗ “Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.” NCT01669291 ↗ |
| Known as | Lupron Depot | “Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix...” NCT03311555 ↗9“Choice of LHRHa per investigator discretion/site practice guidelines (e.g, Eligard®, Zoladex®, Lupron Depot®, Trelstar®) and ARN-509 Tablets, 240 mg/day administered orally” NCT01790126 ↗ “During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.” NCT00451958 ↗ “Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle every 28 days starting at day 0.” NCT00295750 ↗ “Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection” NCT00455689 ↗ |
| Known as | Lupron-Depot-3 | “to compare the effectiveness of norethindrone acetate (NA) with GnRH agonist (Lupron-Depot-3) in relieving symptoms of endometriosis” NCT00458458 ↗ |
| Known as | Prostap | “For GnRHa, there are 3 options available. 1. "Leuprorelin"/"Prostap" or "Staladex".” NCT06832774 ↗ |
| Known as | PT105R | “After a single administration of PT105R (leuprorelin acetate 3.75mg), a single administration of PT105 (leuprorelin acetate 3.75mg)” NCT04783636 ↗ |
| Known as | Staladex | “For GnRHa, there are 3 options available. 1. "Leuprorelin"/"Prostap" or "Staladex".” NCT06832774 ↗ |
| Known as | T Leuprolide Injectable Emulsion | “Drug: T Leuprolide Injectable Emulsion” NCT06449027 ↗ |
| Known as | TAP-144-SR | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01546623 ↗ |
| Known as | Viadur | “Viadur™” NCT03809000 ↗1“Viadur” NCT00005044 ↗ |
| Action | Activate | “GnRH agonist” NCT00001259 ↗ |
| Modality | Other / unclassified | “GnRH agonist” NCT00001322 ↗ |
| Route | Intramuscular | “Leuprolide Acetate 3.75 mg given intramuscularly monthly” NCT00001259 ↗ |