Peptide reference
Leuprolide
Leuprorelin ·Lupron ·Lupron Depot ·Eligard ·Fensolvi ·Camcevi
What cited sources report about Leuprolide
Leuprolide (international nonproprietary name: leuprorelin) is a synthetic nonapeptide GnRH (LHRH) agonist that produces an initial gonadotropin surge followed by sustained pituitary desensitization and chemical castration. Long-acting depot formulations are FDA-approved across multiple oncologic, gynecologic, and pediatric indications. The summaries below report what individual cited sources state; this page does not assert claims beyond what those sources report.
FDA DailyMed — Lupron Depot prescribing information
The current US prescribing information for Lupron Depot lists palliative treatment of advanced prostate cancer, management of endometriosis (3.75 mg monthly or 11.25 mg every 3 months, with optional norethindrone add-back), preoperative hematologic improvement of anemia caused by uterine leiomyomata when administered with iron therapy, and central precocious puberty (Lupron Depot-PED). The label documents the well-known initial gonadotropin and testosterone surge during the first weeks of therapy.
LUPRON DEPOT is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostate cancer.
FDA DailyMed — Eligard prescribing information
Eligard is a polymer-based subcutaneous depot formulation of leuprolide acetate (Atrigel delivery system) marketed in 7.5 mg (1-month), 22.5 mg (3-month), 30 mg (4-month), and 45 mg (6-month) dose strengths. The DailyMed prescribing information lists palliative treatment of advanced prostate cancer as its sole approved indication.
Sharifi, Gulley, and Dahut (2005) — JAMA
A clinical review from the National Cancer Institute that surveyed androgen deprivation therapy in prostate cancer. The authors described GnRH agonists, including leuprolide and goserelin, as the pharmacologic backbone of medical castration and noted the importance of brief antiandrogen co-administration to mitigate the initial testosterone flare.
Hornstein et al. (1998) — Obstetrics & Gynecology
A 12-month randomized add-back study in 95 women with endometriosis assigned to leuprolide depot 3.75 mg monthly with placebo or with norethindrone 5 mg daily. The authors reported that pelvic-pain reduction was sustained over 12 months in both groups, while bone-mineral-density loss was reduced in the norethindrone add-back arm.
ClinicalTrials.gov NCT00103571 — Eligard 6-month depot
The registry record describes an open-label, multicenter long-term safety and pharmacokinetic study of Eligard 45 mg (leuprolide acetate 6-month depot) in patients with advanced prostate cancer, sponsored by Sanofi-Aventis. The 6-month depot was subsequently approved by the FDA.
PubChem CID 657181 — National Center for Biotechnology Information
PubChem record for leuprolide listing the synthetic nonapeptide pyroGlu-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt, molecular formula C59H84N16O12, molecular weight 1209.4 g/mol, and aggregated synonyms (leuprorelin, Lupron, Enantone).
Coverage notes
Leuprolide is the most widely prescribed GnRH agonist worldwide and one of the longest-marketed therapeutic peptides, with a broad evidence base in advanced prostate cancer, endometriosis, uterine fibroids, and central precocious puberty. Multiple depot formulations (1-, 3-, 4-, and 6-month) and routes (IM and SC) are approved. This page reflects FDA labeling current as of the cited sources.