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Evidence boundaries, not cross-trial treatment outcomes
Molecule	Afamelanotide / Melanotan I	Melanotan II	PT-141 (Bremelanotide)
Research Topic	Tissue / Repair Research	Tissue / Repair Research	Sexual Medicine Pharmacology
Pharmacology	Alpha-MSH analogue / melanocortin signalling	Experimental cyclic melanocortin peptide	Cyclic heptapeptide / melanocortin receptor agonist
PrimeCore Class	Class AApproved in a bounded context	Class CExperimental / limited evidence	Class AApproved in a bounded context
Evidence Grade	Grade AStrong regulatory + clinical evidence	Grade CEarly human evidence	Grade AStrong regulatory + clinical evidence
Evidence boundary	Afamelanotide in Scenesse is authorised in the EU for prevention of phototoxicity in adults with EPP. EPP trials do not support routine cosmetic tanning. An online Melanotan I vial is not authenticated Scenesse, and neither is Melanotan II. Approval under exceptional circumstances includes ongoing evidence obligations.	Melanotan II is distinct from afamelanotide and bremelanotide. TGA's 17 August 2026 advisory found inconsistent content in tested nasal products and states there are no authorised Melanotan II products in Australia. FDA lists serious case reports and impurity/immunogenicity concerns; these do not quantify causality or universal incidence.	PT-141 is a development code for bremelanotide. FDA approval applies to the specific Vyleesi product for acquired, generalized HSDD in defined premenopausal women—not to men, performance enhancement or every online PT-141 product.
Unknowns	Insufficient data in the current dataset	Insufficient data in the current dataset	Insufficient data in the current dataset
Limitations	English translation is not yet verified for 1 excerpt(s). This is a language gap, not an absence of risks or uncertainty. Read original excerpts (Thai / mixed language) Scenesse ≠ online Melanotan I vial ≠ Melanotan II; การอนุมัติสำหรับโรคหายากไม่ใช่คำรับรอง cosmetic tanning	English translation is not yet verified for 1 excerpt(s). This is a language gap, not an absence of risks or uncertainty. Read original excerpts (Thai / mixed language) ประโยชน์ของยาที่ออกฤทธิ์ melanocortin ตัวอื่นไม่โอนไป Melanotan II; Grade C ไม่ใช่คำรับรอง cosmetic use	The pivotal evidence concerns a narrowly defined group of predominantly U.S. premenopausal women and uses patient-reported desire and distress endpoints. It does not answer efficacy or safety questions for men, postmenopausal women, general libido enhancement, erectile dysfunction, performance or unverified formulations. A later methodological critique characterised several observed effects as small and questioned some outcome-measure validity; this does not reverse FDA approval but is relevant to interpreting effect size and certainty.
Sources	EMA · Scenesse EPAR EMA · withdrawn adolescent-indication variation EPP randomised trials · PMID 26132941	FDA · significant compounding safety risks; Melanotan II entry Pilot phase I · PMID 8637402 TGA laboratory safety advisory · 17 August 2026	https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000MultidisciplineR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210557Orig1s000ltr.pdf https://pubmed.ncbi.nlm.nih.gov/31599840/ https://pubmed.ncbi.nlm.nih.gov/36809187/ https://www.accessdata.fda.gov/cms_ia/importalert_190.html https://precision.fda.gov/ginas/app/ui/substances/be0ce9ff-94bb-4761-9658-5c5a0a59b6ce https://www.ema.europa.eu/en/medicines https://products.mhra.gov.uk/ https://pertento.fda.moph.go.th/FDA_SEARCH_DRUG/SEARCH_DRUG/FRM_SEARCH_DRUG.aspx https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
Read more	Read English overview Complete evidence profile (Thai)	Read English overview Complete evidence profile (Thai)	Read English overview Complete evidence profile (Thai)

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Missing fields mean information is unavailable in the current structured dataset, not that a molecule has no risks or uncertainties. English translations retain the original evidence boundaries. Where translation is not yet verified, the original Thai excerpts remain available under an explicit label. Sources retain their original language.

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