{"slug":"kisspeptin-10","seoKey":"kisspeptin10","displayName":"Kisspeptin-10","codes":["KP-10","KP10","NSC 741805"],"synonyms":["metastin 45-54","KP-10","kisspeptin 112-121","kisspeptin-10 (human)","human metastin 45-54"],"legalClass":"investigational","identifiers":{"cas":"374675-21-5","pubchemCid":25240297,"unii":"FS1N52VS3S","inchikey":"RITKWYDZSSQNJI-INXYWQKQSA-N","chemblId":"CHEMBL376756","formula":"C63H83N17O14","molecularWeight":1302.4,"sequence":"YNWNSFGLRF-NH2"},"approvals":[{"market":"US","status":"investigational","date":"2023-09-29","note":"Not approved; no entry in the FDA drug approval records and no approved labelling found on 2026-09-10. Named explicitly in category 2 of the bulk drug substances nominated for compounding that may present significant safety risks, nominated under section 503A, with an entry date of 29 September 2023, citing immunogenicity risk for certain routes of administration and complexities with peptide-related impurities. Human use continues under investigational protocols.","source":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"},{"market":"EU","status":"investigational","note":"Not approved; no centralised marketing authorisation and no ATC code assigned, a WHO index query on 2026-09-10 returning no match. Human use took place as an investigational medicinal product. The medicines database could not be queried directly on 2026-09-10, the search returning HTTP 401; the negative finding therefore rests on the missing ATC code and on the absence of any authorised product in all other registers checked.","source":"https://www.ema.europa.eu/en/medicines?search_api_fulltext=kisspeptin"},{"market":"DE","status":"investigational","note":"Not approved; a substance with a medicinal purpose may not be placed on the market without an authorisation, and use outside clinical trials is not provided for. Not listed in annexes I, II or III of the narcotics act, the full text of all three annexes having been searched on 2026-09-10 with no match.","source":"https://www.gesetze-im-internet.de/amg_1976/__21.html"},{"market":"UK","status":"investigational","note":"Not approved; human use takes place in ethics-approved studies only. Not verified against a primary regulator document on 2026-09-10; the assessment rests on the publication and trial registry record.","source":"https://products.mhra.gov.uk/search/?search=kisspeptin"},{"market":"AU","status":"not_approved","note":"Not approved and not named in the Poisons Standard; the full text of the 2026 edition was searched on 2026-09-10 for the peptide and its older trivial name with no match, while control terms in the same document were found. The register of therapeutic goods could not be queried, the request timing out on 2026-09-10. Absence of a listing does not make the substance freely available, since unapproved therapeutic goods remain regulated.","source":"https://www.legislation.gov.au/F2026L00633/asmade"},{"market":"CA","status":"not_approved","note":"Not approved; the drug product database returned an empty result for the active ingredient on 2026-09-10, while a control query in the same endpoint returned 49 entries. The negative finding is therefore verified.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=kisspeptin"},{"market":"CH","status":"not_approved","note":"Not approved. Not verified against a primary regulator document on 2026-09-10; the assessment is derived from the absence of any authorised product in every register that could be queried.","source":"https://www.swissmedicinfo.ch/"}],"devStage":"phase2","strongestEvidence":"rct_phase1","wada":{"status":"prohibited","section":"S2.2.1","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT00914823","name":"Kisspeptin administration in the adult","phase":"Phase 1","n":256,"status":"COMPLETED"},{"nct":"NCT01438073","name":"Elucidating kisspeptin physiology by blocking kisspeptin signalling","phase":"Phase 1","n":96,"status":"COMPLETED"},{"nct":"NCT01952782","name":"Neuropeptides in human reproduction","phase":"Phase 1","n":61,"status":"COMPLETED"},{"nct":"NCT01438034","name":"Kisspeptin in the evaluation of delayed puberty","phase":"Phase 1","n":24,"status":"COMPLETED"},{"nct":"NCT04648969","name":"Prolonged pulsatile kisspeptin administration in hypogonadotropic hypogonadism","phase":"Phase 2","n":18,"status":"COMPLETED"},{"nct":"NCT05633966","name":"Kisspeptin administered subcutaneously in reproductive disorders","phase":"Phase 1","n":13,"status":"COMPLETED"},{"nct":"NCT05971849","name":"Dampening the reproductive axis with continuous kisspeptin","phase":"Phase 1","n":8,"status":"COMPLETED"},{"nct":"NCT05896293","name":"Kisspeptin administered subcutaneously in idiopathic hypogonadotropic hypogonadism","phase":"Phase 2","n":36,"status":"RECRUITING"},{"nct":"NCT07224438","name":"Kisspeptin administered subcutaneously in hypothalamic amenorrhoea","phase":"Phase 2","n":20,"status":"RECRUITING"},{"nct":"NCT07224490","name":"Kisspeptin to quantify GnRH neuronal function in health and disease","phase":"Phase 1","n":40,"status":"RECRUITING"},{"nct":"NCT03286517","name":"Sensitivity of kisspeptin signalling and pubertal onset in boys","phase":"Phase 3 (as registered)","n":30,"status":"COMPLETED"},{"nct":"NCT03771326","name":"Kisspeptin-10 and insulin secretion in men","phase":"Phase 3 (as registered)","n":14,"status":"COMPLETED"},{"nct":"NCT03315325","name":"Age-dependent responsiveness of the hypothalamic pituitary gonadal axis in men","phase":"Phase 3 (as registered)","n":15,"status":"COMPLETED"},{"nct":"NCT05456854","name":"Kisspeptin-stimulated insulin secretion with hyperglycaemic clamp","phase":"Phase 1","n":0,"status":"WITHDRAWN"},{"nct":"NCT04532801","name":"Kisspeptin glucose-stimulated insulin secretion with mixed meal tolerance","phase":"Phase 1","n":0,"status":"WITHDRAWN"}],"sameAs":["https://pubchem.ncbi.nlm.nih.gov/compound/25240297","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL376756/"],"lastVerified":"2026-09-10","version":"1.0","published":true,"locale":"en","title":"Kisspeptin-10: what the studies show, status and safety","summary":"Kisspeptin-10 is a short piece of a peptide the human body makes itself. It acts in the hypothalamus, one step above the hormone GnRH, and briefly raises luteinising hormone and testosterone in men. No country has approved it, and the American medicines authority lists it as a compounding ingredient that may present significant safety risks. Its central finding is that the effect reverses: given continuously instead of in pulses, it suppresses the hormone axis rather than stimulating it.","updated":"2026-09-10","url":"https://mypep.app/peptides/kisspeptin-10"}