{"slug":"pt-141","seoKey":"pt141","inn":"bremelanotide","displayName":"PT-141","codes":["PT-141","PT 141","PT141","BMT"],"synonyms":["bremelanotide","Bremelanotid","Bremelanotidum","Bremelanotida","bremelanotide acetate","PT-141 free base","N-acetyl-L-norleucyl-L-alpha-aspartyl-L-histidyl-D-phenylalanyl-L-arginyl-L-tryptophyl-L-lysine (2->7)-lactam"],"legalClass":"rx","identifiers":{"cas":"189691-06-3","pubchemCid":9941379,"unii":"6Y24O4F92S","inchikey":"FFHBJDQSGDNCIV-MFVUMRCOSA-N","drugbankId":"DB11653","chemblId":"CHEMBL2070241","wikidataQid":"Q415353","formula":"C50H68N14O10","molecularWeight":1025.2,"sequence":"Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH"},"approvals":[{"market":"US","status":"approved_rx","date":"2019-06-21","note":"Approved and prescription-only, granted on 2019-06-21 as a new molecular entity under application NDA 210557, with a labelling supplement approved on 2020-10-23. The single indication is acquired, generalised hypoactive sexual desire disorder in premenopausal women. The product is actively marketed: the national drug code is listed as finished and current, the marketing start under the present holder is 2025-11-12 and the label was last revised on 2025-11-13.","source":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bremelanotide%22"},{"market":"EU","status":"not_approved","note":"Never approved AND never applied for — not a mere absence of a record. Four independent primary queries on 2026-09-17, each secured with control terms found in the same document: the union register of valid authorisations returned nothing (controls present), the union register of no-longer-valid authorisations returned nothing (controls present; this is precisely the list in which a withdrawn authorisation would have to appear), the agency dataset of public assessment reports returned nothing (controls present), and the agency dataset of withdrawn marketing applications returned nothing (control present). The widespread claim that a European authorisation existed and was later taken back is therefore incorrect.","source":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_nact.htm ; https://www.ema.europa.eu/system/files/documents/other/medicines_output_withdrawn_applications_en.xlsx"},{"market":"DE","status":"not_approved","note":"Not approved: there is neither a centralised EU authorisation nor a national one, so no marketable finished medicinal product exists. The substance is not named in annex 1 of the prescription-only ordinance either, verified on 2026-09-17 against control terms present in the same document, including the two other melanocortin agents. In practice that question is secondary: without an authorisation, supply from abroad would fall under the single-import rule of the medicines act and requires a prescription in any case. The substance is also absent from the annex to the anti-doping act.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html ; https://www.gesetze-im-internet.de/antidopg/anlage.html"},{"market":"UK","status":"not_approved","note":"Not approved; the regulator's full-text product index returned no entry on 2026-09-17, for the substance name and for the brand name alike. The index was answering: control queries in the same index returned 106, 269, 3 and 2 hits for comparable substances. Supply would only be conceivable as an unlicensed medicine against a prescription.","source":"https://products.mhra.gov.uk/search/?search=bremelanotide"},{"market":"AU","status":"unknown","note":"NOT VERIFIED — no finding either way. The register of therapeutic goods was unreachable from the working environment on 2026-09-17 (connection dropped over HTTP/2, timed out after 90 seconds over HTTP/1.1, and timed out through the fetch service as well), so no register extract exists. The full text of the Poisons Standard could not be obtained either, because the federal register serves it only through a script-driven application, so it could not be checked whether the substance is captured by name or as a class. This entry deliberately records ignorance rather than an unverified negative.","source":"https://www.tga.gov.au/resources/artg?search_api_fulltext=bremelanotide"},{"market":"CA","status":"not_approved","note":"Not approved; the drug product database holds neither a product nor an active-ingredient entry. Queried through the regulator's interface on 2026-09-17 by ingredient and by brand name, both returning empty lists, with control queries in the same interface returning entries for comparable substances and brands.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=bremelanotide&lang=en&type=json"},{"market":"CH","status":"not_approved","note":"Not approved; the substance appears in none of the published lists of authorised human medicines. The extended workbook was searched in full on 2026-09-17 across 29,625 text cells for the substance name and the brand name, both returning nothing, while control terms returned 19, 2 and 15 matches in the same file.","source":"https://www.swissmedic.ch/swissmedic/en/home/services/listen_neu.html"}],"devStage":"approved","strongestEvidence":"rct_phase3","wada":{"status":"not_listed","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT02333071","name":"RECONNECT study 301 (registration trial 1)","phase":"Phase 3","n":723,"status":"COMPLETED"},{"nct":"NCT02338960","name":"RECONNECT study 302 (registration trial 2, identical protocol)","phase":"Phase 3","n":714,"status":"COMPLETED"},{"nct":"NCT01382719","name":"Phase 2b dose-ranging trial under the skin","phase":"Phase 2","n":612,"status":"COMPLETED"},{"nct":"NCT03973047","name":"Rate of nausea after a single dose, alone or with an antiemetic","phase":"Phase 1","n":228,"status":"COMPLETED"},{"nct":"NCT04943068","name":"Korean bridging trial KD-BMT-301 (no results posted)","phase":"Phase 3","n":193,"status":"COMPLETED"},{"nct":"NCT06565611","name":"Combination with tirzepatide in obesity, four arms (no results posted)","phase":"Phase 2","n":108,"status":"ACTIVE_NOT_RECRUITING"},{"nct":"NCT04179734","name":"Academic mechanism study of the MC4 receptor using functional imaging","phase":"Phase 4","n":40,"status":"COMPLETED"},{"nct":"NCT05709444","name":"Diabetic kidney disease, open label and single arm (no results posted)","phase":"Phase 2","n":16,"status":"COMPLETED"},{"nct":"NCT06867835","name":"Concentration in breast milk after a single dose in lactating women","phase":"Phase 4","n":10,"status":"COMPLETED"},{"nct":"NCT00425256","name":"Early phase 2 trial in female sexual arousal disorder (enrolment not stated in the registry)","phase":"Phase 2","status":"COMPLETED"}],"sameAs":["https://www.wikidata.org/wiki/Q415353","https://pubchem.ncbi.nlm.nih.gov/compound/9941379","https://go.drugbank.com/drugs/DB11653","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2070241/"],"lastVerified":"2026-09-17","version":"1.0","published":true,"locale":"en","title":"PT-141: what the trials show, status and safety","summary":"PT-141, known by its international name bremelanotide, is a melanocortin receptor agonist approved in the United States in 2019 for premenopausal women with distressing low sexual desire. It is licensed nowhere else, and the European Union has never granted or even been asked for an approval. The two approval trials met their targets with a gain of about a third of a point on a six-point desire scale, while dropout for side effects was roughly twelve times higher than on placebo.","updated":"2026-09-17","url":"https://mypep.app/peptides/pt-141"}