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Oncology · FDA Approved

Leuprolide (Lupron) - Oncology

FDA-approved

Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

A GnRH agonist used in oncology for androgen deprivation therapy (ADT) in prostate cancer. Continuous administration downregulates pituitary GnRH receptors, suppressing testosterone to castrate levels after an initial temporary surge (flare), which can be blunted by giving an antiandrogen.

Depot formulations provide sustained release lasting from one to several months.

02 · Research summary & key findings

First FDA-approved in 1985 (Lupron) for advanced prostate cancer. A 1984 randomized trial found leuprolide therapeutically equivalent to diethylstilbestrol for metastatic prostate cancer, with fewer side effects such as painful gynecomastia and thromboembolism but more hot flashes (PMID 6436700). Randomized trials of radiotherapy plus long-term androgen suppression with an LHRH agonist (goserelin) showed improved overall survival in locally advanced prostate cancer, supporting ADT with this drug class (PMID 12126818). GnRH agonist ADT is associated with higher risks of diabetes and cardiovascular disease (PMID 16983113) and of fracture (PMID 15647578).

03 · Regulatory status

Leuprolide (Lupron) - Oncology has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Leuprolide (Lupron) - Oncology 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.

04 · Administration routes

  • Intramuscular injection (depot)
  • Subcutaneous injection

References

  1. [1]Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial Lancet, 2002. PMID 12126818
  2. [2]Risk of fracture after androgen deprivation for prostate cancer N Engl J Med, 2005. PMID 15647578
  3. [3]Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer J Clin Oncol, 2006. PMID 16983113
  4. [4]Leuprolide versus diethylstilbestrol for metastatic prostate cancer N Engl J Med, 1984. PMID 6436700

Primary literature

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.