Peptide reference
Gonadorelin
GnRH ·LHRH ·Luteinizing Hormone-Releasing Hormone ·Factrel ·Lutrepulse ·Gonadorelin acetate ·Gonadorelin hydrochloride
What cited sources report about gonadorelin
Gonadorelin is the synthetic form of endogenous gonadotropin-releasing hormone (GnRH), a decapeptide secreted by the hypothalamus that drives pituitary release of LH and FSH. The molecule was historically marketed in the US for human use as Factrel (intravenous diagnostic GnRH stimulation test) and Lutrepulse (pulsatile-pump therapy for hypothalamic amenorrhea). Cited sources indicate that the human-labeled US products are no longer actively marketed; current US labels in DailyMed are veterinary. International approvals persist in some jurisdictions, and the substance is available in compounded form. The summaries below report what individual cited sources state; this page does not assert claims beyond what those sources report.
Santoro (1990) — American Journal of Obstetrics and Gynecology
A multicenter clinical trial reported at the time of the Lutrepulse US launch enrolled 109 women with hypothalamic amenorrhea and characterized the safety and efficacy of intravenous pulsatile gonadorelin. The author reported high ovulation rates, a 12% multiple-pregnancy rate, and a side-effect profile that the trial sponsors characterized as comparable to human menopausal gonadotropin therapy.
Pulsatile gonadotropin-releasing hormone treatment appears to be of at least comparable efficacy to human menopausal gonadotropins, with the added benefit of reduced overall risks.
Saadedine et al. (2023) — Mayo Clinic Proceedings
A clinical review of functional hypothalamic amenorrhea characterized the disorder as a disruption of pulsatile GnRH secretion driven by psychosocial stress, eating restriction, and excessive exercise. The authors discussed pulsatile GnRH (gonadorelin) historically and noted that current management emphasizes reversing the underlying behavioral and energetic drivers, with US availability of pulsatile-pump gonadorelin products limited.
DailyMed — National Library of Medicine
A DailyMed search for “gonadorelin” returned five labeled US products — Cystorelin, Factrel (Zoetis), Fertagyl, Gonabreed, and Ovacyst — each labeled for animal-health use. No active human-drug label for gonadorelin (Factrel/Lutrepulse human formulations) was returned in the search result set as of this writing, consistent with the historical discontinuation of those NDAs in the US human market.
PubChem CID 638793 — National Center for Biotechnology Information
The PubChem compound record for gonadorelin lists molecular formula C55H75N17O13 and identifies the substance as the synthetic decapeptide identical to endogenous GnRH/LHRH (pyroGlu-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH2). The record aggregates synonyms — including GnRH, LHRH, and luliberin — and links to the underlying chemical and pharmacological literature.
Coverage notes
Gonadorelin is a historically approved human drug whose US human-labeled products (Factrel, Lutrepulse) are no longer reflected as active labels in DailyMed; the current DailyMed records for “gonadorelin” are veterinary. This page therefore records fda_approval: withdrawn for the human market, recognizing that the underlying chemistry and clinical experience date to the 1980s-1990s. The substance remains available through 503A compounding channels and is approved in some non-US jurisdictions; this page does not catalog the full international approval history. Anyone relying on gonadorelin therapy clinically should consult current FDA Orange Book and DailyMed records directly.