Reproductive · FDA Approved
Leuprolide (Lupron)
FDA-approved
01 · Overview
A synthetic nonapeptide GnRH agonist that is more potent and longer-acting than native GnRH. After an initial stimulatory phase (flare effect), chronic leuprolide administration downregulates pituitary GnRH receptors, resulting in profound suppression of LH, FSH, and downstream sex steroids.
This medical castration effect is used in treating hormone-sensitive prostate cancer, endometriosis, and central precocious puberty.
02 · Research summary & key findings
FDA-approved for advanced prostate cancer, endometriosis, uterine fibroid-related anemia (preoperative), and central precocious puberty; use in IVF protocols is off-label. Across 1-, 3-, 4-, and 6-month subcutaneous depot formulations, 90-97% of men with advanced prostate cancer maintained testosterone at or below 20 ng/dL (PMID 26991743). In the phase 3 EMBARK trial in high-risk biochemically recurrent prostate cancer, adding enzalutamide to leuprolide significantly improved overall survival versus leuprolide alone (PMID 41124201).
03 · Regulatory status
Leuprolide (Lupron) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Leuprolide (Lupron) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
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Leuprolide (Lupron) is prescribed for the conditions on its label, and it is not part of our intake. If you are working on hormone optimization, a licensed clinician can tell you at a free consultation whether an FDA-approved or lawfully compounded treatment fits you, or whether nothing does.
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04 · Administration routes
- Subcutaneous injection
- Intramuscular injection (depot)
References
- [1]Polymer-delivered subcutaneous leuprolide acetate formulations achieve and maintain castrate concentrations of testosterone in four open-label studies in patients with advanced prostate cancer BJU Int, 2017. PMID 26991743
- [2]Improved Survival with Enzalutamide in Biochemically Recurrent Prostate Cancer N Engl J Med, 2026. PMID 41124201
Primary literature
- PubMed: "Leuprolide"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Leuprolide"
Registered interventional and observational studies, including status and phase.
- PubChem: "Leuprolide"
Chemical structure, molecular properties, and bioactivity data.
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