GnRH antagonist

Ganirelix updates

Answer

6 changes for Ganirelix in the last 12 months. Latest: 2026-07-28.

DateTypeWhat changedSource
2026-07-28TrialNew trial registered: Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized ContrTrial register ClinicalTrials.gov
2026-05-11LabelFDA label revised: Ganirelix Acetate (ANDA218855)Regulator FDA drug label register
2026-03-18LabelFDA label revised: Ganirelix Acetate (ANDA215658)Regulator FDA drug label register
2026-02-06TrialNew trial registered: IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist ProtocolsTrial register ClinicalTrials.gov
2025-12-17RecallFDA recall, Class II: Lupin Pharmaceuticals Inc.. Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impRegulator FDA enforcement reports
2025-11-13LabelFDA label revised: Ganirelix Acetate (NDA021057)Regulator FDA drug label register
2025-09-03LabelFDA label revised: Ganirelix Acetate (ANDA216075)Regulator FDA drug label register
2025-07-15LabelFDA label revised: Ganirelix Acetate (ANDA218855)Regulator FDA drug label register
2025-07-11TrialNew trial registered: hCG Priming in Women With Diminished Ovarian ReserveTrial register ClinicalTrials.gov
2025-03-10TrialNew trial registered: Is the Diurnal Variation in Circulating Levels of Cortisol Reflected in Follicular Fluid of Preovulatory Follicles Close to Ovulation?Trial register ClinicalTrials.gov
2025-02-20LabelFDA label revised: Ganirelix Acetate (ANDA214996)Regulator FDA drug label register
2025-01-06LabelFDA label revised: Fyremadel (ANDA204246)Regulator FDA drug label register
2024-12-20TrialNew trial registered: Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife WomenTrial register ClinicalTrials.gov
2024-10-15TrialNew trial registered: Protocol with Progestin-primed Ovarian Stimulation (PPOS) from the Beginning of Stimulation Versus Protocol with GnRH Antagonists for Ovarian StimulTrial register ClinicalTrials.gov
2024-07-01TrialNew trial registered: Possible Action of Resveratrol in Improving the Outcomes of IVF/ICSI in Couples With Unexplained InfertilityTrial register ClinicalTrials.gov
2024-05-22LabelFDA label revised: Ganirelix Acetate (ANDA215658)Regulator FDA drug label register
2024-05-17Federal RegisterFederal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; AvailabilityRegulator Federal Register
2024-02-15TrialNew trial registered: Impact of IVF Hormonal Therapy on Endometrial Receptivity and Endometrial Senescent Cell Pathological AccumulationTrial register ClinicalTrials.gov
2024-02-02ResultsResults posted: Mechanisms of Hypertension in Women With Polycystic Ovary SyndromeTrial register ClinicalTrials.gov
2023-11-29LabelFDA label revised: GANIRELIX ACETATE (ANDA215658)Regulator FDA drug label register
2023-11-28TrialNew trial registered: PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over StudyTrial register ClinicalTrials.gov
2023-10-19TrialNew trial registered: To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as ReferenceTrial register ClinicalTrials.gov
2023-08-16TrialNew trial registered: To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female SubjectsTrial register ClinicalTrials.gov
2023-07-20TrialNew trial registered: Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.Trial register ClinicalTrials.gov
2023-05-03RecallFDA recall, Class II: Sun Pharmaceutical Industries Ltd.. Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.Regulator FDA enforcement reports
2023-04-07TrialNew trial registered: DPOS Versus GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: An RCTTrial register ClinicalTrials.gov
2023-03-02TrialNew trial registered: Sub-therapeutic GnRH- Antagonist Treatment to Rectify LH Pulsatility in Lean Women With PCOS.Trial register ClinicalTrials.gov
2023-02-15ResultsResults posted: Coenzyme Q10 Phase III Trial in Gulf War IllnessTrial register ClinicalTrials.gov
2022-04-19LabelFDA label revised: Ganirelix Acetate (ANDA212613)Regulator FDA drug label register
2021-10-22ResultsResults posted: An Observational Study of Follitropin Alpha Biosimilar: the Real-world DataTrial register ClinicalTrials.gov
2021-10-08TrialNew trial registered: GnRH Antagonist Pre-treatment for the Prevention of Asynchronous Follicular GrowthTrial register ClinicalTrials.gov
2021-08-06TrialNew trial registered: GnRH Antagonist Pre-treatment in the Early Follicular Phase for Resolution of a Baseline Functional Ovarian CystTrial register ClinicalTrials.gov
2021-07-05TrialNew trial registered: INTEnsity of ovariaN Stimulation and Embryo QualityTrial register ClinicalTrials.gov
2021-06-15ResultsResults posted: Delayed Start to Ovarian StimulationTrial register ClinicalTrials.gov
2021-04-18TrialNew trial registered: An Observational Study of Follitropin Alpha Biosimilar: the Real-world DataTrial register ClinicalTrials.gov
2021-04-14RecallFDA recall, Class II: SUN PHARMACEUTICAL INDUSTRIES INC. Failed Impurities/Degradation SpecificationsRegulator FDA enforcement reports
2020-12-30TrialNew trial registered: Desogestrel Versus GnRH Antagonist in IVF/ICSITrial register ClinicalTrials.gov
2020-12-24ResultsResults posted: Sex Hormones and Atherosclerosis Prevention in Perimenopausal WomenTrial register ClinicalTrials.gov
2020-12-04TrialNew trial registered: The Rate of Embryo Euploidy in Progestin-primed Ovarian Stimulation CyclesTrial register ClinicalTrials.gov
2020-11-05TrialNew trial registered: DEPO-Trigger Trial: GnRH Agonist DEPOt TRIGGER for Final Oocyte MaturationTrial register ClinicalTrials.gov
2020-08-11TrialNew trial registered: Combining Interventions of Fertility Preservation to Mitigate Fertility Loss After Breast CancerTrial register ClinicalTrials.gov
2020-06-18TrialNew trial registered: The LUTEAL Trial: Luteal Stimulation vs. Estrogen Priming ProtocolTrial register ClinicalTrials.gov
2020-05-26TrialNew trial registered: Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian ResponseTrial register ClinicalTrials.gov
2020-05-26TrialNew trial registered: Corifollitropin Alpha and Ovarian ResponseTrial register ClinicalTrials.gov
2020-05-09TrialNew trial registered: "Study of the Effects of Serum and Follicular Fluid Relaxin Levels on Ovarian Function in IVF Cycles"Trial register ClinicalTrials.gov
2019-11-16TrialNew trial registered: Anti-Müllerian Hormone (AMH) Measured With Fully Automated Assay Versus AFC in the Prediction of Ovarian ResponseTrial register ClinicalTrials.gov
2019-11-13TrialNew trial registered: Ovarian Hyperstimulation and Fibrin Clot Properties.Trial register ClinicalTrials.gov
2019-09-20TrialNew trial registered: Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.Trial register ClinicalTrials.gov
2019-08-28TrialNew trial registered: Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female InfertilityTrial register ClinicalTrials.gov
2019-07-30TrialNew trial registered: Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal WomenTrial register ClinicalTrials.gov
2019-03-01TrialNew trial registered: Single Follicular Dexarelix for LH Suppression During Ovarian Stimulation in Oocyte Donors.Trial register ClinicalTrials.gov
2018-10-17TrialNew trial registered: Mechanisms of Hypertension in Women With Polycystic Ovary SyndromeTrial register ClinicalTrials.gov
2018-05-17TrialNew trial registered: Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular PhaseTrial register ClinicalTrials.gov
2018-05-08TrialNew trial registered: Luteal Phase-start Ovarian Stimulation With Corifollitropin AlfaTrial register ClinicalTrials.gov
2018-03-27TrialNew trial registered: Cetrorelix and Ganirelix Flexible Protocol for (IVF)Trial register ClinicalTrials.gov
2017-10-04TrialNew trial registered: Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors. Undergoing Ovarian StimulationTrial register ClinicalTrials.gov
2017-10-03TrialNew trial registered: Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response PatientTrial register ClinicalTrials.gov
2017-09-18TrialNew trial registered: DuoStim in Cases of PGT: Comparison of Embryo Quantity and Embryonic Quality Using MitoScoreTrial register ClinicalTrials.gov
2017-07-28TrialNew trial registered: Menopause Effects on Vascular FunctionTrial register ClinicalTrials.gov
2017-05-08TrialNew trial registered: Hormonal Mechanisms of Sleep Restriction - Axis StudyTrial register ClinicalTrials.gov
2017-02-13TrialNew trial registered: To Compare and Evaluate the Efficacy and Safety of Ganilever PFS(Prefilled Syringe) and Orgalutran®Trial register ClinicalTrials.gov
2017-01-30ResultsResults posted: Sex Hormones and Orthostatic ToleranceTrial register ClinicalTrials.gov
2016-09-13TrialNew trial registered: Letrozole in Stimulated IVF CyclesTrial register ClinicalTrials.gov
2016-07-28TrialNew trial registered: Coenzyme Q10 Phase III Trial in Gulf War IllnessTrial register ClinicalTrials.gov
2016-06-07TrialNew trial registered: Progevera 10 mg® Versus Orgalutran® in Ovarian Stimulation Cycles of Oocyte DonorsTrial register ClinicalTrials.gov
2015-12-21TrialNew trial registered: Effectiveness and Safety Study of Fixed Versus Flexible of Gonadotropin-releasing Hormone Antagonist ProtocolTrial register ClinicalTrials.gov
2015-05-05ResultsResults posted: Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)Trial register ClinicalTrials.gov
2015-04-30ResultsResults posted: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)Trial register ClinicalTrials.gov
2015-04-27ResultsResults posted: To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-Trial register ClinicalTrials.gov
2015-04-25TrialNew trial registered: Letrozole in Assisted Reproductive TechnologyTrial register ClinicalTrials.gov
2015-03-18TrialNew trial registered: Type of Gonadotropin and Embryo Kinetics of DevelopmentTrial register ClinicalTrials.gov
2014-11-24ResultsResults posted: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)Trial register ClinicalTrials.gov
2014-11-20ResultsResults posted: Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)Trial register ClinicalTrials.gov
2014-08-21ResultsResults posted: A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily RecombinaTrial register ClinicalTrials.gov
2014-04-21TrialNew trial registered: Effect of Treatment With Corifollitropin Alpha in Vitro Fertilization in Patients With Poor Ovarian Response.Trial register ClinicalTrials.gov
2014-02-24TrialNew trial registered: Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct for Egg Bank DonationTrial register ClinicalTrials.gov
2013-12-18TrialNew trial registered: Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSITrial register ClinicalTrials.gov
2013-06-21TrialNew trial registered: Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus AntagonistTrial register ClinicalTrials.gov
2013-03-22TrialNew trial registered: Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders TrialTrial register ClinicalTrials.gov
2013-02-19TrialNew trial registered: Endometrial Injury and IVF Outcome Parameters in Patients With Failed IVF CyclesTrial register ClinicalTrials.gov
2012-08-09TrialNew trial registered: Effect of GnRH Antagonist vs Agonist Long on IVF Outcome, Peak Estradiol Level,and Duration of StimulationTrial register ClinicalTrials.gov
2012-07-20TrialNew trial registered: Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian StimulationTrial register ClinicalTrials.gov
2012-07-05TrialNew trial registered: The Results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of Embryos Obtained From GnRH-agonist Long and GnRH-antagonisTrial register ClinicalTrials.gov
2012-06-07TrialNew trial registered: Delayed Start to Ovarian StimulationTrial register ClinicalTrials.gov
2012-05-16TrialNew trial registered: An Efficacy and Safety Study of Corifollitropin Alfa (MK-8962) in Contrast to Recombinant FSH for Use in Controlled Ovarian Stimulation of Indian WoTrial register ClinicalTrials.gov
2012-04-30TrialNew trial registered: Addition of Prednisolone and Heparin in Patients Undergoing IVF With Failed IVF CyclesTrial register ClinicalTrials.gov
2011-11-16TrialNew trial registered: Proteomics & Glyco-Proteomic Analysis of Follicular FluidTrial register ClinicalTrials.gov
2011-08-30ResultsResults posted: MENOPUR® Versus FOLLISTIM®Trial register ClinicalTrials.gov
2011-08-29TrialNew trial registered: A Novel Approach to Endometrial Preparation in Recipients of Donor EggsTrial register ClinicalTrials.gov
2011-08-22TrialNew trial registered: Effect of Oocyte Vitrification on Fertilization Rate, Embryo Quality and DevelopmentTrial register ClinicalTrials.gov
2011-02-25TrialNew trial registered: Post-Marketing Surveillance of the Safety and Efficacy of Orgalutran (Ganirelix)®Trial register ClinicalTrials.gov
2011-01-31TrialNew trial registered: Single Injection of Ganirelix in Gonadotropin Intrauterine Insemination (IUI) CyclesTrial register ClinicalTrials.gov
2010-12-06TrialNew trial registered: Proposed Research Protocol For Male InfertilityTrial register ClinicalTrials.gov
2010-12-02ResultsResults posted: Trial Comparing Start Stimulation of Recombinant Follicle Stimulating Hormone (rFSH) on Cycle Day 2 Versus Cycle Day 5 in In Vitro Fertilization (IVF)Trial register ClinicalTrials.gov
2010-10-08TrialNew trial registered: Pretreatment With Estradiol ValerateTrial register ClinicalTrials.gov
2010-09-21TrialNew trial registered: Ovarian Response Prediction in In Vitro Fertilization (IVF) PatientsTrial register ClinicalTrials.gov
2010-06-30TrialNew trial registered: Sex Hormones and Orthostatic ToleranceTrial register ClinicalTrials.gov
2010-05-28TrialNew trial registered: A Comparative Study of Two Patterns of Controlled Ovarian Hyperstimulation in Mid Follicular Phase or Early Luteal Phase for Egg DonorsTrial register ClinicalTrials.gov
2010-01-22ResultsResults posted: A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro FerTrial register ClinicalTrials.gov
2009-10-02TrialNew trial registered: Japanese Bridging Trial of Org 37462 (Study P05969)(COMPLETED)Trial register ClinicalTrials.gov

The 100 newest of 136 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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