{"slug":"melanotan-i","seoKey":"melanotan1","inn":"afamelanotide","displayName":"Melanotan I","codes":["CUV1647","CUV-1647","EPT1647","MT-1"],"synonyms":["afamelanotide","afamelanotidum","NDP-alpha-MSH","NDP-MSH","Melanotan-1","[Nle4, D-Phe7]-alpha-MSH"],"legalClass":"rx","identifiers":{"cas":"75921-69-6","pubchemCid":16197727,"unii":"QW68W3J66U","inchikey":"UAHFGYDRQSXQEB-LEBBXHLNSA-N","drugbankId":"DB04931","chemblId":"CHEMBL441738","wikidataQid":"Q410794","formula":"C78H111N21O19","molecularWeight":1646.85,"sequence":"Ac-Ser-Tyr-Ser-Nle-Glu-His-(D)Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2"},"approvals":[{"market":"US","status":"approved_rx","date":"2019-10-08","note":"Approved and prescription-only, as a subcutaneous implant. The single indication is to increase pain free light exposure in adults with a history of phototoxic reactions from a rare inherited porphyria. Priority review, orphan designation, no boxed warning.","source":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210797Orig1s000ltr.pdf"},{"market":"EU","status":"approved_rx","date":"2014-12-22","note":"Authorised centrally under exceptional circumstances and subject to restricted medical prescription. Prescribing is reserved to specialists in recognised porphyria centres, and administration to clinicians accredited by the authorisation holder. Orphan medicine under additional monitoring.","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/scenesse"},{"market":"DE","status":"approved_rx","date":"2014-12-22","note":"Authorised through the centralised EU procedure and prescription-only under the German Medicines Act, with the same European restriction to specialist porphyria centres and accredited administration. The German marketing and reimbursement status could not be verified from an official primary source on 2026-09-06.","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/scenesse"},{"market":"UK","status":"approved_rx","note":"Authorised under exceptional circumstances for the same rare porphyria indication, with prescribing restricted to specialist porphyria centres. Highly specialised technologies guidance of 2023-07-26 does not recommend it within its marketing authorisation, so it is not funded by the health service.","source":"https://www.nice.org.uk/guidance/hst27"},{"market":"AU","status":"scheduled","note":"Listed in the Poisons Standard as Schedule 4, prescription only, with an index cross-reference from the Melanotan I name. No entry for a finished medicinal product could be retrieved on 2026-09-06; the regulator states that melanotan products are not registered and may not be supplied.","source":"https://www.legislation.gov.au/F2026L00633/asmade"},{"market":"CA","status":"approved_rx","date":"2026-07-09","note":"Approved and classified as prescription, as a subcutaneous implant with a risk management plan covering education, monitoring and a registry. The database records no market entry date, so the product was authorised but not yet marketed on 2026-09-06.","source":"https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=107203"},{"market":"CH","status":"not_approved","note":"No marketing authorisation; the list of authorised human medicinal products of 2026-09-06 contains no entry. Before the EU authorisation the substance was supplied to patients for years through a compassionate use programme.","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":"NCT01605136","name":"Confirmatory study in erythropoietic protoporphyria","phase":"Phase 3","n":93,"status":"COMPLETED"},{"nct":"NCT04053270","name":"Multicentre study in erythropoietic protoporphyria","phase":"Phase 3","n":100,"status":"COMPLETED"},{"nct":"NCT04704713","name":"Polymorphic light eruption","phase":"Phase 3","n":31,"status":"COMPLETED"},{"nct":"NCT04578496","name":"Safety extension in erythropoietic protoporphyria","phase":"Phase 3","n":16,"status":"COMPLETED"},{"nct":"NCT00472901","name":"Polymorphic light eruption","phase":"Phase 3","n":18,"status":"COMPLETED"},{"nct":"NCT01097044","name":"Confirmatory study in erythropoietic protoporphyria","phase":"Phase 2","n":77,"status":"COMPLETED"},{"nct":"NCT04525157","name":"With narrow-band ultraviolet B phototherapy in vitiligo","phase":"Phase 2","n":21,"status":"COMPLETED"},{"nct":"NCT00859534","name":"Solar urticaria pilot study","phase":"Phase 2","n":5,"status":"COMPLETED"},{"nct":"NCT04943159","name":"Acne vulgaris","phase":"Phase 2","n":3,"status":"COMPLETED"},{"nct":"NCT04962503","name":"Proof of concept, safety","phase":"Phase 2","n":6,"status":"COMPLETED"},{"nct":"NCT05854784","name":"Variegate porphyria","phase":"Phase 2","n":6,"status":"COMPLETED"},{"nct":"NCT05159752","name":"Xeroderma pigmentosum","phase":"Phase 2","n":6,"status":"UNKNOWN"},{"nct":"NCT05370235","name":"Xeroderma pigmentosum","phase":"Phase 2","n":6,"status":"UNKNOWN"},{"nct":"NCT01430195","name":"With narrow-band ultraviolet B in non-segmental vitiligo","phase":"Phase 1","n":56,"status":"COMPLETED"},{"nct":"NCT05368857","name":"DNA repair capacity after ultraviolet exposure","phase":"Phase 1","n":10,"status":"COMPLETED"}],"sameAs":["https://www.wikidata.org/wiki/Q410794","https://pubchem.ncbi.nlm.nih.gov/compound/16197727","https://go.drugbank.com/drugs/DB04931","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL441738/"],"lastVerified":"2026-09-06","version":"1.0","published":true,"locale":"en","title":"Melanotan I: what the studies show, status and safety","summary":"Melanotan I and afamelanotide are two names for one peptide, but not for one product. As afamelanotide it is an approved prescription medicine in the European Union, the United States and Canada, for a single rare inherited disease that makes sunlight painful. The approved form is a small implant placed under the skin by trained staff in specialist centres, so every injectable sold as \"Melanotan I\" is unapproved by definition. In the American licensing trial, patients spent a median of 69.4 hours of pain-free time in direct sunlight over six months, against 40.8 hours on a dummy implant.","updated":"2026-09-06","url":"https://mypep.app/peptides/melanotan-i"}