Source comparison
Melanotan-1 FDA Approved Status: Comparison
Scenesse (afamelanotide 16mg implant) FDA-approved (2019) Prescription only, specialty pharmacies Erythropoietic protoporphyria (EPP) Full cGMP, batch testing, traceability Only FDA-recognised form of afamelanotide. Cannot be compounded or prescribed off-label
This comparison does not assign a generated winner or score.
- Scenesse (afamelanotide 16mg implant)
- FDA-approved (2019)
- Prescription only, specialty pharmacies
- Erythropoietic protoporphyria (EPP)
- Full cGMP, batch testing, traceability
- Only FDA-recognised form of afamelanotide. Cannot be compounded or prescribed off-label for cosmetic use
- Injectable Melanotan-1 (lyophilised peptide)
- Unapproved new drug
- Illegal for human use; sold as 'research chemical'
- None
- No FDA oversight; no sterility or potency guarantees
- Identical active molecule to Scenesse but lacks regulatory approval, standardised dosing, or safety verification
- Compounded afamelanotide
- Not approved; no 503B exemption
- Illegal. Compounding of Scenesse is prohibited
- Prohibited under FDA compounding rules
- Compounding pharmacies cannot legally produce afamelanotide in any form. Scenesse's approval explicitly excludes compounding
- Melanotan-2 (bremelanotide analog)
- No FDA oversight
- Structurally distinct from Melanotan-1; higher MC4R affinity; associated with more severe cardiovascular side effects