{"slug":"gonadorelin","seoKey":"gonadorelin","inn":"gonadorelin","displayName":"Gonadorelin","codes":["H01CA01","V04CM01","GnRH","LHRH"],"synonyms":["GnRH","GnRH-I","LHRH","LH-RH","luteinising hormone-releasing hormone","gonadoliberin","gonadorelinum","gonadoreline","gonadorelina","gonadorelin acetate","gonadorelin hydrochloride","LH-releasing factor","gonadotropin-releasing factor","mammalian GnRH"],"legalClass":"rx","identifiers":{"cas":"33515-09-2","pubchemCid":638793,"unii":"9O7312W37G","inchikey":"XLXSAKCOAKORKW-AQJXLSMYSA-N","drugbankId":"DB00644","wikidataQid":"Q20817116","chemblId":"CHEMBL1007","formula":"C55H75N17O13","molecularWeight":1182.3,"sequence":"pGlu-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH2"},"approvals":[{"market":"US","status":"not_approved","note":"Not approved for human use today, though formerly approved and always prescription-only: two applications existed, one from 1982-09-30 as a new molecular entity and one from 1989-10-10 as a new active ingredient. Every strength of both is listed as discontinued in the regulator's database, which records no date for the withdrawal; four targeted full-text searches of the federal gazette returned no announcement, because its index does not reach back that far. No human product remains in the labelling archive, while veterinary products for cattle stay approved and actively marketed under their own applications.","source":"https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22GONADORELIN*%22"},{"market":"EU","status":"not_approved","note":"No centralised marketing authorisation: the agency's full medicines export, checked on 2026-09-10, contains no entry, while control queries for comparable substances in the same file return records, so the null finding is not a query error. Authorisations exist only through national procedures of individual member states; in Spain the national database returned no entry against a working control query. Outside the union, national authorisations remain in force in the United Kingdom and Switzerland.","source":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx"},{"market":"DE","status":"scheduled","note":"The substance is named without any restriction in annex 1 of the prescription-only ordinance and may therefore be dispensed only against a doctor's prescription, regardless of any authorisation. It is additionally named in the annex to the anti-doping act, in the section on chorionic gonadotrophin, luteinising hormone and their releasing factors; unlike the international list, the national annex draws no distinction by sex. Finished products are listed in a commercial drug database, but no official register was reachable from the working environment on 2026-09-10, so their current marketing status is not verified and the status field records the substance-level rule only.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html"},{"market":"UK","status":"approved_rx","date":"2001-05-25","note":"Authorised as a prescription-only medicine, first on 2001-05-25 and renewed on 2004-06-25, with the product information last revised on 2022-10-07. The indication is diagnostic only: a single injection to evaluate the functional capacity and response of the gonadotropes of the anterior pituitary, including residual function after removal of a pituitary tumour, surgery or irradiation. The labelling states expressly that this test identifies neither the underlying cause of a subnormal response nor the pituitary reserve.","source":"https://products.mhra.gov.uk/search/?search=gonadorelin"},{"market":"AU","status":"scheduled","date":"2026-05-28","note":"Named in schedule 4 of the poisons standard, the schedule for prescription-only medicines, in the instrument registered on 2026-05-28. The entry carries no hash mark, so the additional controls of appendix D do not apply. Scheduling attaches to the substance itself; whether any finished product is entered in the register of therapeutic goods could not be checked, because that database was unreachable from the working environment on 2026-09-10.","source":"https://www.legislation.gov.au/F2026L00633"},{"market":"CA","status":"not_approved","date":"2024-12-24","note":"No human product on the market: all seven human entries in the drug product database are cancelled post market or dormant, the earliest cancelled in 1996 and the latest on 2024-12-24, with one further entry dormant since 2017. A control query for a comparable substance returned records in the same interface, so the finding is not a query error. Veterinary products remain authorised and actively marketed under six identification numbers.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=gonadorelin&lang=en&type=json"},{"market":"CH","status":"approved_rx","note":"Authorised for an unlimited term and prescription-only in dispensing category B, entered as a biotechnological product for the pulsatile treatment of hypothalamic amenorrhoea and of central hypogonadism in men. The entry was confirmed on 2026-09-10 in both published lists of authorised human medicines, the extended indication list and the pack list.","source":"https://www.swissmedic.ch/swissmedic/en/home/services/listen_neu.html"}],"devStage":"approved","strongestEvidence":"meta_analysis","wada":{"status":"prohibited","section":"S2.2.1","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT01278290","name":"Comparative validation of a stimulation test for suspected central precocious puberty in girls","n":46,"status":"COMPLETED"}],"sameAs":["https://www.wikidata.org/wiki/Q20817116","https://pubchem.ncbi.nlm.nih.gov/compound/638793","https://go.drugbank.com/drugs/DB00644","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1007/"],"lastVerified":"2026-09-10","version":"1.0","published":true,"locale":"en","title":"Gonadorelin: what the studies show, status and safety","summary":"Gonadorelin is a copy of the hormone the brain uses to switch on the sex glands. It is prescription-only, still approved in Britain and Switzerland but discontinued in North America. Given as pulses from a pump, it restored ovulation in nearly every treated cycle in hypothalamic amenorrhoea. The popular claim that it replaces hCG during testosterone therapy has never been studied.","updated":"2026-09-10","url":"https://mypep.app/peptides/gonadorelin"}