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Gonadorelin
GnRH, LHRH, gonadorelin acetate, gonadorelin hydrochloride, Factrel, Lutrepulse
REC PPT-GONADORELIN // REV 2026-10-04 // assessment changes are logged, never silent
Synthetic gonadotropin-releasing hormone: genuinely FDA approved in the past as a pituitary diagnostic and as a pulsatile fertility therapy, both now discontinued in the United States, while the version circulating today in male hormone contexts sits outside any approved human label.
What it is
Gonadorelin is a synthetic decapeptide identical in sequence to endogenous hypothalamic gonadotropin-releasing hormone (GnRH, also called LHRH). Given as a bolus it triggers the anterior pituitary to release luteinising hormone and follicle-stimulating hormone; its circulating half-life is on the order of minutes.
What it does
Historically used as a diagnostic agent to test anterior pituitary gonadotropic function, and by pump-delivered pulsatile administration to induce ovulation in primary hypothalamic amenorrhoea. It remains an FDA-approved veterinary drug in cattle. It also circulates in compounded male hormone practice, a use no approved human label covers.
Does it work?
Raw counts measured 2026-08-25 look large — 1,996 indexed publications, 56 randomised controlled trials and 1,186 ClinicalTrials.gov records — but they do not survive inspection. The 56 trials include unrelated GnRH-analogue and gonadal-steroid papers, and the registry figure is a fuzzy expansion across the whole gonadotropin field rather than studies of gonadorelin itself. What is solid is old and narrow: the acute LH and FSH response underpinning the pituitary stimulation test, and the pulsatile-pump ovulation-induction literature behind the discontinued Lutrepulse product. For the use that drives current interest — supporting testicular function in men on exogenous testosterone — no controlled human trial evidence for gonadorelin was located, and its half-life of minutes makes sustained gonadotropin support from intermittent injection difficult to reason about from pharmacology alone.
Claims vs data
Each marketing claim, tagged by what the evidence actually supports.
| Triggers a measurable rise in LH and FSH within minutes of administration | supported |
| Pulsatile pump-delivered administration can induce ovulation in primary hypothalamic amenorrhoea | supported |
| Pulsatile regimens raise testosterone in men with hypogonadotropic hypogonadism | partially true |
| Maintains testicular size and fertility in men using testosterone therapy | overreach |
Reference figures
Quoted from published reference material. These are not Peptuity recommendations.
molecular data — PubChem CID 638793
The evidence, counted
Live counts from Europe PMC and ClinicalTrials.gov.
2,034 publications indexed, including 57 randomised controlled trials. 1194 interventional studies registered. This is a well-tested compound.
SRC // EUROPE PMC + CTGOV // "Gonadorelin" // FETCHED 2026-10-04 // 2,034 RECORDS
Most-cited literature
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[01]
Sex bias in neuroscience and biomedical research
Beery AK, Zucker I. · Neurosci Biobehav Rev 2011 · 1371 citations · DOI 10.1016/j.neubiorev.2010.07.002
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[02]
Chemistry and biology of multicomponent reactions
Dömling A, Wang W, Wang K. · Chem Rev 2012 · 962 citations · DOI 10.1021/cr100233r
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[03]
APP processing in Alzheimer's disease
Zhang YW, Thompson R, Zhang H, Xu H. · Mol Brain 2011 · 711 citations · DOI 10.1186/1756-6606-4-3
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[04]
Identification of a new class of steroid hormone receptors
Giguère V, Yang N, Segui P, Evans RM. · Nature 1988 · 625 citations · DOI 10.1038/331091a0
Regulatory status
Formal, dated regulatory actions.
US FDA — human, discontinued 2026-08
Factrel (gonadorelin hydrochloride), application NDA 018123, originally approved 30 September 1982 for evaluating gonadotropic function of the anterior pituitary. All strengths are listed as Discontinued in Drugs@FDA; current sponsor of record Hikma.
US FDA — human, discontinued 2026-08
Lutrepulse Kit (gonadorelin acetate), application NDA 019687, originally approved 10 October 1989 by Ferring for pulsatile administration. Both vial strengths are listed as Discontinued in Drugs@FDA.
US FDA — veterinary, current 2026-08
Factrel Injection, gonadorelin hydrochloride 50 mcg/mL, approved under NADA 139-237 for use in cattle only — treatment of ovarian follicular cysts and, with Lutalyse, synchronisation of oestrus for fixed-time artificial insemination. Restricted by federal law to use by or on the order of a licensed veterinarian. This is an animal approval and says nothing about human use.
Common questions
Was gonadorelin ever FDA approved for humans?
Yes. Factrel (gonadorelin hydrochloride, NDA 018123) was approved on 30 September 1982 and Lutrepulse Kit (gonadorelin acetate, NDA 019687) on 10 October 1989. Both are listed as discontinued in the FDA Drugs@FDA database, so no approved human gonadorelin product is marketed in the United States today.
Why was it discontinued?
The Drugs@FDA record states only that the products are discontinued; it does not state a reason. No withdrawal for safety has been confirmed from FDA records. Absence of a stated safety reason is not the same as a documented safety finding, and neither should be read into the other.
Is it still an approved drug anywhere?
Yes, in veterinary medicine. Factrel Injection (gonadorelin hydrochloride, 50 mcg/mL) holds FDA approval under NADA 139-237 for cattle only, for ovarian follicular cysts and for oestrous synchronisation, restricted to use by or on the order of a licensed veterinarian.
What is its status in sport?
Gonadorelin is prohibited at all times under WADA category S2, in the sub-section covering luteinising-hormone releasing factors, and that prohibition applies in males only. Female athletes are not caught by that entry. Athletes should confirm the current wording directly with WADA.
Related compounds
HCG
Approved gonadotropin. The weight-loss ‘HCG diet’ is separately discredited.
HMG
Menotropins — an established fertility medicine.
Kisspeptin-10
Key reproductive-axis regulator with real academic research behind it.
TRH
The compound sold as research TRH is protirelin, a synthetic tripeptide that the FDA approved decades ago purely as a pituitary diagnostic; both approved US products are discontinued, and the enormous publication count attached to the name belongs to the endogenous hormone, not to the product.