GnRH agonist

Leuprolide updates

Answer

50 changes for Leuprolide in the last 12 months. Latest: 2026-09-03.

DateTypeWhat changedSource
2026-09-03TrialNew trial registered: Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast CancerTrial register ClinicalTrials.gov
2026-09-02ResultsResults posted: Contributions to Hypertension With Androgen Deprivation TherapyTrial register ClinicalTrials.gov
2026-08-31ResultsResults posted: Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)Trial register ClinicalTrials.gov
2026-08-24Federal RegisterFederal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; AvailabilityRegulator Federal Register
2026-08-20TrialNew trial registered: QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant ChemotherapyTrial register ClinicalTrials.gov
2026-08-06TrialNew trial registered: A Phase Ia Trial Comparing the Pharmacokinetics/Pharmacodynamics, Safety, and Preliminary Efficacy of HHK001 and Enantone in Patients With EndometriTrial register ClinicalTrials.gov
2026-08-03TrialNew trial registered: Phase Ia Trial of HHK001 Compared With Enantone in Patients With EndometriosisTrial register ClinicalTrials.gov
2026-07-25TrialNew trial registered: Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate CancerTrial register ClinicalTrials.gov
2026-07-11TrialNew trial registered: Tolerability of Dalpiciclib vs. Abemaciclib/Ribociclib in Early HR+/HER2- Breast CancerTrial register ClinicalTrials.gov
2026-07-07TrialNew trial registered: Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer.Trial register ClinicalTrials.gov
2026-07-06TrialNew trial registered: A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious PubertyTrial register ClinicalTrials.gov
2026-07-02ResultsResults posted: Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients WiTrial register ClinicalTrials.gov
2026-06-16TrialNew trial registered: Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE TrialTrial register ClinicalTrials.gov
2026-06-15ResultsResults posted: Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide AcetateTrial register ClinicalTrials.gov
2026-05-28LabelFDA label revised: leuprolide acetate (ANDA215336)Regulator FDA drug label register
2026-05-27ResultsResults posted: Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed TumorsTrial register ClinicalTrials.gov
2026-05-25LabelFDA label revised: LEUPROLIDE ACETATE (ANDA215826)Regulator FDA drug label register
2026-05-19LabelFDA label revised: Leuprolide Acetate (ANDA074728)Regulator FDA drug label register
2026-05-14TrialNew trial registered: Impact of Formulation Change on Ovarian Suppression in Young Breast Cancer Patients.Trial register ClinicalTrials.gov
2026-05-13TrialNew trial registered: BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed HypoTrial register ClinicalTrials.gov
2026-05-08LabelFDA label revised: LEUPROLIDE ACETATE (ANDA212963)Regulator FDA drug label register
2026-04-30LabelFDA label revised: Vabrinty (NDA021379)Regulator FDA drug label register
2026-04-30LabelFDA label revised: Eligard (NDA021379)Regulator FDA drug label register
2026-04-24LabelFDA label revised: leuprolide acetate (ANDA078885)Regulator FDA drug label register
2026-04-23LabelFDA label revised: Leuprolide Acetate (ANDA075471)Regulator FDA drug label register
2026-04-21TrialNew trial registered: A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate CancerTrial register ClinicalTrials.gov
2026-04-13ResultsResults posted: AASUR in High Risk Prostate CancerTrial register ClinicalTrials.gov
2026-04-09ResultsResults posted: Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate CancerTrial register ClinicalTrials.gov
2026-04-03ResultsResults posted: Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGWTrial register ClinicalTrials.gov
2026-03-29LabelFDA label revised: leuprolide acetate (ANDA217957)Regulator FDA drug label register
2026-03-15LabelFDA label revised: Lupron Depot (NDA020517)Regulator FDA drug label register
2026-03-12ResultsResults posted: Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer PatientsTrial register ClinicalTrials.gov
2026-03-06TrialNew trial registered: Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CTTrial register ClinicalTrials.gov
2026-02-24TrialNew trial registered: Rezvilutamide for High-Risk Prostate Cancer After SurgeryTrial register ClinicalTrials.gov
2026-02-18LabelFDA label revised: CAMCEVI (NDA211488)Regulator FDA drug label register
2026-02-13ResultsResults posted: Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate CancerTrial register ClinicalTrials.gov
2026-02-09LabelFDA label revised: LEUPROLIDE ACETATE (ANDA215826)Regulator FDA drug label register
2026-01-29ResultsResults posted: Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in FinlandTrial register ClinicalTrials.gov
2026-01-28TrialNew trial registered: Radiotherapy After Prostatectomy for Node Positive Prostate CancerTrial register ClinicalTrials.gov
2026-01-16LabelFDA label revised: leuprolide acetate (ANDA217957)Regulator FDA drug label register
2026-01-13ResultsResults posted: A Study of Leuprolide Acetate Depot in Children With Central Precocious PubertyTrial register ClinicalTrials.gov
2025-12-28TrialNew trial registered: Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate CancerTrial register ClinicalTrials.gov
2025-12-28TrialNew trial registered: Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)Trial register ClinicalTrials.gov
2025-12-18TrialNew trial registered: Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With Fulvestrant for the TreatmenTrial register ClinicalTrials.gov
2025-12-16TrialNew trial registered: Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER)Trial register ClinicalTrials.gov
2025-12-05ResultsResults posted: The Role of Hormones in Postpartum Mood DisordersTrial register ClinicalTrials.gov
2025-12-05ResultsResults posted: Pembrolizumab +/- SD-101 in Hormone-Naïve Oligometastatic Prostate Cancer With RT and iADTTrial register ClinicalTrials.gov
2025-11-21LabelFDA label revised: Leuprolide Acetate (ANDA213829)Regulator FDA drug label register
2025-11-16TrialNew trial registered: CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate CancerTrial register ClinicalTrials.gov
2025-11-14LabelFDA label revised: Lupron Depot-PED (NDA020263)Regulator FDA drug label register
2025-09-25LabelFDA label revised: Fensolvi (NDA213150)Regulator FDA drug label register
2025-09-22ResultsResults posted: RElugolix VErsus LeUprolide Cardiac TrialTrial register ClinicalTrials.gov
2025-09-18LabelFDA label revised: Lupron Depot (NDA020011)Regulator FDA drug label register
2025-09-18TrialNew trial registered: Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II StudyTrial register ClinicalTrials.gov
2025-09-10LabelFDA label revised: Lupron Depot (NDA020708)Regulator FDA drug label register
2025-09-05TrialNew trial registered: Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS TrialTrial register ClinicalTrials.gov
2025-08-29TrialNew trial registered: Cardiovascular Health of Transgender Individuals During the Gender-affirming PathwayTrial register ClinicalTrials.gov
2025-08-20TrialNew trial registered: Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOTrial register ClinicalTrials.gov
2025-08-19TrialNew trial registered: Supraphysiologic Testosterone Priming Induces Darolutamide Extended ResponseTrial register ClinicalTrials.gov
2025-08-19TrialNew trial registered: A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRHTrial register ClinicalTrials.gov
2025-08-14TrialNew trial registered: Norethindrone Impact on Receptiva OutcomesTrial register ClinicalTrials.gov
2025-08-01ResultsResults posted: Systemic and Tumor-Directed Therapy for Oligometastatic Prostate CancerTrial register ClinicalTrials.gov
2025-08-01TrialNew trial registered: Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate CancerTrial register ClinicalTrials.gov
2025-06-26ResultsResults posted: DeADT - Living Well With Prostate CancerTrial register ClinicalTrials.gov
2025-06-24LabelFDA label revised: Leuprolide Acetate (ANDA213829)Regulator FDA drug label register
2025-06-12ResultsResults posted: Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal HyperplasiaTrial register ClinicalTrials.gov
2025-06-10TrialNew trial registered: Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate CancerTrial register ClinicalTrials.gov
2025-06-03LabelFDA label revised: LUTRATE DEPOT (NDA205054)Regulator FDA drug label register
2025-06-03TrialNew trial registered: A Clinical Study of KLH-2109 in Patients With EndometriosisTrial register ClinicalTrials.gov
2025-05-22TrialNew trial registered: The Study Will Evaluate if Leuprolide Mesylate is Safe and Effective in the Treatment of Subjects With Advanced Prostate Carcinoma, When AdministereTrial register ClinicalTrials.gov
2025-04-15TrialNew trial registered: Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious PubertyTrial register ClinicalTrials.gov
2025-04-03TrialNew trial registered: The COSMYC Trial (COmbined Suppression of MYC)Trial register ClinicalTrials.gov
2025-02-23TrialNew trial registered: Fulvestrant With Ribociclib Versus Physician's Choice Treatments Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+Trial register ClinicalTrials.gov
2025-02-11TrialNew trial registered: Optimal Duration of Hormonal Therapy for Unfavorable Intermediate-risk Prostate Cancer Patients: 6 Versus 12 Months.Trial register ClinicalTrials.gov
2025-01-19TrialNew trial registered: Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP PatientsTrial register ClinicalTrials.gov
2024-12-31ResultsResults posted: Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep ApneaTrial register ClinicalTrials.gov
2024-12-11TrialNew trial registered: Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate CancerTrial register ClinicalTrials.gov
2024-11-26ResultsResults posted: Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based CohortsTrial register ClinicalTrials.gov
2024-10-21TrialNew trial registered: REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac TrialTrial register ClinicalTrials.gov
2024-10-16ResultsResults posted: A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following SurgeryTrial register ClinicalTrials.gov
2024-10-16TrialNew trial registered: Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic HormTrial register ClinicalTrials.gov
2024-10-08ResultsResults posted: Menopausal Sleep Fragmentation and Body Fat GainTrial register ClinicalTrials.gov
2024-09-12TrialNew trial registered: COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcerTrial register ClinicalTrials.gov
2024-08-27LabelFDA label revised: LEUPROLIDE ACETATE DEPOT (NDA205054)Regulator FDA drug label register
2024-07-31ResultsResults posted: A Study of PF-06873600 in People With CancerTrial register ClinicalTrials.gov
2024-07-06TrialNew trial registered: A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung CancerTrial register ClinicalTrials.gov
2024-06-13ResultsResults posted: Brown Adipose Tissue Activity in Pre- and Postmenopausal WomenTrial register ClinicalTrials.gov
2024-06-13TrialNew trial registered: Efficacy and Safety of DKF-MA102 in Patients With Prostate CancerTrial register ClinicalTrials.gov
2024-06-10LabelFDA label revised: LEUPROLIDE ACETATE (ANDA217437)Regulator FDA drug label register
2024-06-07TrialNew trial registered: Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.Trial register ClinicalTrials.gov
2024-05-30TrialNew trial registered: Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate CancerTrial register ClinicalTrials.gov
2024-05-03TrialNew trial registered: ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate CancerTrial register ClinicalTrials.gov
2024-04-30ResultsResults posted: A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local TreatmentTrial register ClinicalTrials.gov
2024-04-29TrialNew trial registered: A Study of Avutometinib, Defactinib, and Letrozole in People With Low-Grade Serous Ovarian CancerTrial register ClinicalTrials.gov
2024-04-23Federal RegisterFederal Register notice: PAI Holdings, LLC DBA Pharmaceutical Associates, Inc., et al.; Withdrawal of Approval of 23 New Drug ApplicationsRegulator Federal Register
2024-04-23TrialNew trial registered: Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage RadiatTrial register ClinicalTrials.gov
2024-04-04TrialNew trial registered: Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct CarcinomaTrial register ClinicalTrials.gov
2024-03-27ResultsResults posted: Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+,Trial register ClinicalTrials.gov
2024-03-26TrialNew trial registered: Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate CancerTrial register ClinicalTrials.gov
2024-03-25ResultsResults posted: Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)Trial register ClinicalTrials.gov

The 100 newest of 740 are listed.

From ClinicalTrials.gov, EU CTIS, FDA labels, recalls, shortages and warning letters, the Federal Register, and regulators' published actions. Not medical advice.

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