{"slug":"sermorelin","seoKey":"sermorelin","inn":"sermorelin","displayName":"Sermorelin","codes":["GRF (1-29)","GHRH(1-29)NH2","H01AC04","V04CD03"],"synonyms":["GRF(1-29)NH2","hGHRH(1-29)NH2","GRF 1-29 amide","sermorelin acetate","sermorelina","sermoreline","sermorelinum","groliberin","growth hormone-releasing factor(1-29) amide"],"legalClass":"rx","identifiers":{"cas":"86168-78-7","pubchemCid":16132413,"unii":"89243S03TE","inchikey":"WGWPRVFKDLAUQJ-MITYVQBRSA-N","chemblId":"CHEMBL428135","wikidataQid":"Q7455005","formula":"C149H246N44O42S","molecularWeight":3357.9},"approvals":[{"market":"US","status":"not_approved","date":"2009-06-18","note":"Not approved today, but formerly approved and always prescription-only: two applications existed, one from 1990-12-28 for assessing the pituitary's capacity to secrete growth hormone, and one from 1997-09-26 for growth hormone deficiency in children with growth failure. Both were withdrawn at the holder's own request, announced on 2009-05-19 and effective on 2009-06-18. The regulator formally determined on 2013-03-04 that neither product was withdrawn for reasons of safety or effectiveness, which keeps generic applications possible; no generic has since been identified. The substance remains available only as a compounded preparation against a prescription, carried by 17 active bulk substance registrations from 16 registrants.","source":"https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-and-other-drug-products-were-not-withdrawn-from"},{"market":"EU","status":"not_approved","note":"No centralised marketing authorisation, neither current nor withdrawn: a full-text search of the agency's medicines directory returned no entry on 2026-09-10, including under withdrawn applications. National authorisations existed in individual member states decades ago, but their numbers and expiry dates could not be reconstructed from any register available today.","source":"https://www.ema.europa.eu/en/medicines?search_api_fulltext=sermorelin"},{"market":"DE","status":"scheduled","note":"No authorised finished medicinal product, but the substance is named in annex 1 of the prescription-only ordinance and may therefore be dispensed only against a doctor's prescription, regardless of any authorisation. A full-text check on 2026-09-10 found it listed by name, alongside the entry for the full-length releasing hormone. It is additionally named in the annex to the anti-doping act, in the section on growth hormone releasing factors.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html"},{"market":"UK","status":"not_approved","note":"No marketing authorisation; the regulator's full-text product index returned no entry on 2026-09-10, verified against a working control query for a comparable substance that returns product characteristic documents in the same index. Supply would only be conceivable as an unlicensed medicine against a prescription.","source":"https://products.mhra.gov.uk/search/?search=sermorelin"},{"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","note":"No marketing authorisation and no drug identification number: queries of the drug product database on 2026-09-10 returned an empty list both for the active ingredient and for the former trade name, while a control query for a comparable substance returned two records, so the interface was working.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=sermorelin&lang=en&type=json"},{"market":"CH","status":"not_approved","note":"No marketing authorisation; the published lists of authorised human medicines contain no entry. A full-text check of both the extended medicines list and the pack list on 2026-09-10 returned no match, while control queries for comparable substances returned matches in the same files, so the lists were populated and searchable.","source":"https://www.swissmedic.ch/swissmedic/en/home/services/listen_neu.html"}],"devStage":"discontinued","strongestEvidence":"rct_phase2","wada":{"status":"prohibited","section":"S2.2.4","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT03018886","name":"Diagnostic testing for growth hormone deficiency in adults, combined with arginine","n":160,"status":"COMPLETED"},{"nct":"NCT00324064","name":"Diagnostic testing in healthy adults and adults with growth hormone deficiency","n":90,"status":"COMPLETED"},{"nct":"NCT01410799","name":"Three-month treatment in older adults (terminated early)","phase":"Phase 2","n":13,"status":"TERMINATED"},{"nct":"NCT00807365","name":"Six-month parallel protocol in older adults (terminated early)","phase":"Phase 2","n":5,"status":"TERMINATED"},{"nct":"NCT00000380","name":"Age-related sleep disturbance in older men and women (no substance form or results on file)","status":"COMPLETED"}],"sameAs":["https://www.wikidata.org/wiki/Q7455005","https://pubchem.ncbi.nlm.nih.gov/compound/16132413","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL428135/"],"lastVerified":"2026-09-10","version":"1.0","published":true,"locale":"en","title":"Sermorelin: what the studies show, status and safety","summary":"Sermorelin is a lab-made copy of the first 29 building blocks of the hormone that tells the pituitary gland to release growth hormone. American regulators approved it twice, first in 1990 as a diagnostic test and then in 1997 for children with growth hormone deficiency. Both approvals ended on 18 June 2009, after the maker asked for them to be withdrawn, and no country licenses the substance today. In the approval trial the growth speed of 110 children rose from 4.1 to 8.0 centimetres a year, yet a review found that growth hormone itself worked better. Germany and Australia name sermorelin in their prescription-only schedules, and the world anti-doping list names it too.","updated":"2026-09-10","url":"https://mypep.app/peptides/sermorelin"}