{"slug":"triptorelin","seoKey":"triptorelin","inn":"triptorelin","displayName":"Triptorelin","codes":["AY-25650","CL-118532","Wy-42462","BIM-21003","Debio-8206","L02AE04"],"synonyms":["D-Trp6-LHRH","[D-Trp6]-LH-RH","triptoreline","triptorelinum","triptorelina","triptorelin acetate","triptorelin pamoate","triptorelin embonate","pGlu-His-Trp-Ser-Tyr-D-Trp-Leu-Arg-Pro-Gly-NH2"],"legalClass":"rx","identifiers":{"cas":"57773-63-4","pubchemCid":25074470,"unii":"9081Y98W2V","inchikey":"VXKHXGOKWPXYNA-PGBVPBMZSA-N","chemblId":"CHEMBL1200554","wikidataQid":"Q1992452","formula":"C64H82N18O13","molecularWeight":1311.4,"sequence":"pGlu-His-Trp-Ser-Tyr-D-Trp-Leu-Arg-Pro-Gly-NH2"},"approvals":[{"market":"US","status":"approved_rx","date":"2000-06-15","note":"Approved and prescription-only, actively marketed. Four separate applications exist: NDA 020715 (3.75 mg, original approval 2000-06-15, submission class 'Type 1 - New Molecular Entity'), NDA 021288 (11.25 mg, 2001-06-29), NDA 022437 (22.5 mg, 2010-03-10) and NDA 208956 (22.5 mg paediatric kit, 2017-06-29). All four finished products are listed as active in the national drug code directory as queried on 2026-09-17. The authorisations cover two fields of use only: advanced prostate carcinoma, and central precocious puberty in patients aged 2 years and over. Endometriosis, uterine fibroids and reproductive medicine are not American fields of use. The directory additionally carries two bulk-ingredient registrations by a named manufacturer, which is the lawful raw-material channel, and a veterinary gel for ovulation synchronisation in pigs.","source":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22triptorelin%22"},{"market":"EU","status":"approved_rx","note":"Prescription-only and long established, but NOT through the centralised procedure: the union register of medicinal products returned no entry on 2026-09-17, in the list of valid authorisations and in the list of lapsed ones alike, while control terms were found in both documents. That is not evidence of absence. The same query returns nothing for goserelin either, because substances of this class were authorised nationally long before the centralised procedure existed. National authorisations are documented here for the United Kingdom, Germany and Switzerland; France, Italy, Spain and further member states carry the same trade names but were not queried individually.","source":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm"},{"market":"DE","status":"approved_rx","note":"Prescription-only and on the market. The substance is named in schedule 1 of the prescription ordinance, without any exception clause and without any limitation to fields of use, dosage forms or maximum quantities, while neighbouring entries in the same list do carry such clauses. The whole class of gonadotropin-releasing hormone analogues is prescription-only in Germany. The German authorisation numbers could not be retrieved from an official primary register: the national databases are entirely JavaScript-driven and returned no machine-readable data on 2026-09-17. The substance is additionally named in the annex to the anti-doping act, section II item 2.1.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html"},{"market":"UK","status":"approved_rx","note":"Approved and prescription-only, with several licences held by different companies: PL 03194/0085 for a 3.75 mg depot, PL 034926/0012 for an 11.25 mg product carrying a field of use entirely outside oncology, and further depot strengths of 3, 11.25 and 22.5 mg. A recall notice dated 2023-03-23 concerned a seal defect at the peel-away opening of the needle blister, not the substance. CAVEAT: the regulator's product index is entirely JavaScript-driven and returned no result list, so these details rest on the published recall notice and on the approved product information texts including their licence numbers, not on a register extract.","source":"https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-ferring-pharmaceuticals-limited-gonapeptyl-depot-3-dot-75mg-powder-and-solvent-for-suspension-for-injection-el-23-a-slash-12"},{"market":"AU","status":"approved_rx","date":"2015-03-04","note":"Registered and prescription-only, with the strictest classification of the seven markets checked: the substance is named in schedule 4 of the poisons standard, so the prescription requirement follows from the substance listing itself, irrespective of trade name or dosage form. The full text of the June 2026 instrument was searched on 2026-09-17; the entry carries no exception clause, and control terms of the same class were found in the same document. Four register entries are documented: 109854, 109856 and 159173 for the depot strengths and 219857 for a 100 microgram pre-filled syringe, the latter registered since 2015-03-04. CAVEAT: the register interface and its detail pages were unreachable from the working environment on that date, so the four numbers come from a domain-restricted search and not from register extracts; the schedule 4 listing is the firmer of the two Australian findings.","source":"https://www.legislation.gov.au/F2026L00633/asmade"},{"market":"CA","status":"approved_rx","date":"2005-12-15","note":"Authorised, marketed and prescription-only. Four human products are recorded: DIN 02240000 (3.75 mg, one-month depot, marketed since 2005-12-15), DIN 02243856 (11.25 mg, three-month depot, same date), DIN 02412322 (22.5 mg, six-month depot, since 2013-10-16) and DIN 02389282 (0.1 mg/ml solution in a pre-filled syringe, since 2012-08-09). A fifth entry, DIN 02424150, is a veterinary gel. All five carry the value 'PRESCRIPTION' in the schedule interface, the veterinary product included.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=triptorelin&type=json"},{"market":"CH","status":"approved_rx","date":"1995-06-29","note":"Approved and prescription-only, six authorisations in total: 47660 (0.1 mg solution in a pre-filled syringe, first authorised 1995-06-29), 53830 (depot, 1998-09-10), 52815 (3.75 mg, 1998-01-14), 56349 (11.25 mg, 2005-02-09), 61238 (22.5 mg, 2011-03-09) and 58543 (2009-07-09). Five sit in dispensing category A and one in category B; both categories require a prescription. All six carry the same classification code. One of them is the earliest authorisation documented anywhere in this record. The listed fields of use differ by product and one authorisation carries four of them at once, which is why the substance cannot be reduced to any single description.","source":"https://www.swissmedic.ch/dam/swissmedic/de/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/Erweiterte_Arzneimittelliste%20HAM.xlsx"}],"devStage":"approved","strongestEvidence":"rct_phase3","wada":{"status":"prohibited","section":"S2.2.1","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT04513717","name":"Treatment de-escalation in high-risk prostate carcinoma (two parallel trials)","phase":"Phase 3","n":2753,"status":"ACTIVE_NOT_RECRUITING"},{"nct":"NCT00003026","name":"Hormone therapy in advanced prostate carcinoma","phase":"Phase 3","n":966,"status":"COMPLETED"},{"nct":"NCT05328258","name":"Fertility protection during chemotherapy","phase":"Phase 3","n":500,"status":"RECRUITING"},{"nct":"NCT00104741","name":"Triptorelin and flutamide with external radiotherapy versus radiotherapy alone","phase":"Phase 3","n":378,"status":"COMPLETED"},{"nct":"NCT03232281","name":"Two formulations compared in Chinese women aged 18 to 45 with endometriosis (open label, active controlled, 24 centres, no placebo arm)","phase":"Phase 3","n":300,"status":"COMPLETED"},{"nct":"NCT02418572","name":"Transdermal testosterone gel in women with poor ovarian response (terminated)","phase":"Phase 3","n":290,"status":"TERMINATED"},{"nct":"NCT01715129","name":"Induction and maintenance of castration after subcutaneous administration of the pamoate","phase":"Phase 3","n":126,"status":"COMPLETED"},{"nct":"NCT01656161","name":"Two subcutaneous injections of the six-month formulation under androgen deprivation","phase":"Phase 3","n":120,"status":"COMPLETED"},{"nct":"NCT00415246","name":"Subcutaneous four-month sustained-release form (terminated)","phase":"Phase 3","n":100,"status":"TERMINATED"},{"nct":"NCT05029622","name":"Six-month formulation in Chinese children with central precocious puberty (single arm, open label, no control group)","phase":"Phase 3","n":66,"status":"COMPLETED"},{"nct":"NCT06795191","name":"FP-014 22.5 mg in advanced prostate carcinoma (withdrawn, no participants enrolled)","phase":"Phase 3","n":0,"status":"WITHDRAWN"},{"nct":"NCT06795178","name":"FP-014 11.25 mg in advanced prostate carcinoma (withdrawn, no participants enrolled)","phase":"Phase 3","n":0,"status":"WITHDRAWN"}],"sameAs":["https://pubchem.ncbi.nlm.nih.gov/compound/25074470","https://www.wikidata.org/wiki/Q1992452","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200554/"],"lastVerified":"2026-09-17","version":"1.0","published":true,"locale":"en","title":"Triptorelin: what the evidence shows, status and safety","summary":"Triptorelin is a synthetic copy of a natural hormone that controls the sex glands, changed at a single position. It is a prescription medicine in every market checked, and unusual: given once it switches the pituitary gland on, given continuously it switches it off. The best-documented long-term harm is bone loss, and several of its uses rest on studies without a placebo group.","updated":"2026-09-17","url":"https://mypep.app/peptides/triptorelin"}