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Home/Compounds/Leuprolide
OtherFDA approvedRx required

Leuprolide

Also known as: Lupron · Eligard · Fensolvi
Brands: Lupron · Lupron Depot · Eligard · Fensolvi

GnRH agonist decapeptide used for prostate cancer, endometriosis, uterine fibroids, and central precocious puberty.

A
Grade A
Multiple human RCTs
Human studies26
PubMed citations29
Routesubcutaneous, intramuscular
Regulatory (US)FDA approved · Rx
Last verified2 days ago

Mechanism of action

Synthetic nonapeptide GnRH agonist. Continuous stimulation initially increases then downregulates pituitary GnRH receptors, producing chemical castration.

Evidence summary

26
Human studies
29
PubMed citations
25
Clinical trials
A
Evidence grade

Evidence summary in progress. See the citations section below for the underlying research papers.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Administration routes
subcutaneousintramuscular

Side effects & safety

From the FDA label
Source
arthralgiaconstipationdizzinessdyspepsiafatigueheadacheinsomnianauseapruritusvomiting

Terms pulled directly from the referenced source. We don't fabricate frequencies — when a label doesn't publish a percentage, we don't either.

Interactions

No documented drug interactions on file.

Regulatory status

United States
FDA approved

FDA approved for prostate cancer, endometriosis, uterine fibroids, central precocious puberty, and other indications (Lupron, Eligard, Fensolvi)

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT05567198Efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by QuestionnairesRecruiting · Systemic Lupus Erythematosus (Sle) · n=100NCT07134920BCL6 Positivity and ART Outcomes: Comparing Norethindrone Acetate and Depo Lupron for Endometriosis Suppression Prior to Embryo TransferCompleted · Infertility (IVF Patients) · n=99NCT05827081A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)Recruiting · Phase 3 · Early Breast Cancer · n=1400NCT02772588ARN-509+Abiraterone Acetate+Leuprolide With Stereotactic, Ultra-Hypofractionated Radiation (AASUR) in Very High Risk Prostate Cancer: A Single Arm, Phase II StudyCompleted · Phase 2 · Prostate Cancer · n=64NCT02960022A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical StudyRecruiting · Phase 2 · Prostate Cancer · n=900NCT04557059A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET With an Observational CohortActive Not Recruiting · Phase 3 · Prostatic Neoplasms · n=693NCT06169124A Phase II Study of Androgen Receptor (AR) Inhibition by Darolutamide in Combination With Leuprolide Acetate and Exemestane in Recurrent Adult-Type Ovarian Granulosa Cell TumorActive Not Recruiting · Phase 2 · Adult Ovarian Granulosa Cell Tumor · n=37NCT02346253A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate CancerActive Not Recruiting · N/A · Prostate Adenocarcinoma · n=146NCT03361735A Phase 2 Trial of Radium Ra 223 Dichloride in Combination With Androgen Deprivation Therapy and Stereotactic Body Radiation Therapy for Patients With Oligometastatic Castration Sensitive Prostate CancerActive Not Recruiting · Phase 2 · Prostate Adenocarcinoma · n=25NCT04787744Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer (VA STARPORT)Recruiting · Phase 2 · Prostate Cancer · n=464NCT05050084Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)Active Not Recruiting · Phase 3 · Prostate Adenocarcinoma · n=2050NCT04760691A Phase I Trial for the Evaluation of the Two-way Pharmacokinetic-pharmacodynamic (PD) Interaction of Gender Affirming Exogenous Estrogen (With Testosterone Suppression) on TDF/FTC PrEP in Transgender Women (TGW)Completed · Phase 1 · HIV · n=13

Showing 12 of 25 indexed studies. View all on ClinicalTrials.gov →

Citations

PMID 41260291Evans JR, Krishnan V et al. · Sterile Abscess Following Intramuscular Leuprolide Acetate Injection for Endometriosis: A Case Report.Journal of pediatric and adolescent gynecology (2026)HumanPMID 41349040Shore ND, De Giorgi U et al. · Enzalutamide Monotherapy for the Treatment of Prostate Cancer With High-Risk Biochemical Recurrence: EMBARK Secondary End Points.The Journal of urology (2026)HumanPMID 41124201Shore ND, Luz MA et al. · Improved Survival with Enzalutamide in Biochemically Recurrent Prostate Cancer.The New England journal of medicine (2026)HumanPMID 41274168Shore ND, De Giorgi U et al. · Enzalutamide with or without leuprolide in patients with high-risk biochemically recurrent prostate cancer: EMBARK post hoc analysis by age.European journal of cancer (Oxford, England : 1990) (2026)HumanPMID 40680199Li EV, Ho AY et al. · Adverse Cardiovascular Outcomes of Individuals Treated With Androgen Deprivation Therapy.Urology practice (2025)HumanPMID 38718766Breidbart E, Breidbart E et al. · Precocious Puberty and GnRH Analogs: Current Treatment Practices and Perspectives among US Pediatric Endocrinologists.Hormone research in paediatrics (2025)HumanPMID 39555581Shore ND, Cookson MS et al. · The landscape of androgen deprivation therapies for the treatment of advanced prostate cancer.Future oncology (London, England) (2025)HumanPMID 40189880Hafron J, Hong A et al. · Study of persistence and adherence to ADT in prostate cancer: relugolix, degarelix, and GnRH agonists in the US.Future oncology (London, England) (2025)HumanPMID 39153499Steen EA, Phillips SA · Transient synovitis associated with leuprolide depot (Lupron).Endocrinology, diabetes & metabolism case reports (2024)PMID 38143206Tutrone R, Saad F et al. · Testosterone Recovery for Relugolix Versus Leuprolide in Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study.European urology oncology (2024)HumanPMID 37851874Freedland SJ, de Almeida Luz M et al. · Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer.The New England journal of medicine (2023)HumanPMID 36907533Foster KI, Flores Legarreta A et al. · Clinical outcomes of leuprolide acetate in the treatment of recurrent ovarian granulosa cell tumors.American journal of obstetrics and gynecology (2023)HumanPMID 37543781Zheng Y, Ma R et al. · Efficacy and safety of different subsequent therapies after fertility preserving surgery for endometriosis: A systematic review and network meta-analysis.Medicine (2023)HumanPMID 37266535Valenzise M, Nasso C et al. · Leuprolide and triptorelin treatment in children with idiopathic central precocious puberty: an efficacy/tolerability comparison study.Frontiers in pediatrics (2023)HumanPMID 35976565Abulateefeh SR · Long-acting injectable PLGA/PLA depots for leuprolide acetate: successful translation from bench to clinic.Drug delivery and translational research (2022)PMID 33480983Desai K, McManus JM et al. · Hormonal Therapy for Prostate Cancer.Endocrine reviews (2022)HumanPMID 34570375Teoh JY, Tian XY et al. · Endothelial dysfunction after androgen deprivation therapy and the possible underlying mechanisms.The Prostate (2022)PMID 32469183Shore ND, Saad F et al. · Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer.The New England journal of medicine (2020)HumanPMID 32167701de Freitas CSM, Soares AN · Efficacy of Leuprorelide acetate (Eligard®) in daily practice in Brazil: a retrospective study with depot formulations in patients with prostate cancer.International braz j urol : official journal of the Brazilian Society of Urology (2020)HumanPMID 29197875Ohlmann CH, Gross-Langenhoff M · Efficacy and Tolerability of Leuprorelin Acetate (Eligard®) in Daily Practice in Germany: Pooled Data from 2 Prospective, Non-Interventional Studies with 3- or 6-Month Depot Formulations in Patients with Advanced Prostate Cancer.Urologia internationalis (2018)Human

Showing 20 of 29 papers. View all on PubMed →