Approved drug (Scenesse implant, EPP) — profile from its trials and label; research vials are not the implant
Afamelanotide is approved as a subcutaneous implant for erythropoietic protoporphyria, so controlled human data exist: implant-site reactions, nausea, headache and darkening of existing moles are the documented effects. Research-grade 'MT1' powder is an injectable of unverified identity, not the implant, and has no trial data of its own.
Research-use information only. Research-grade Melanotan I is not an approved medicine; where trial or label figures appear below they belong to the pharmaceutical product studied, not to any research vial. This page does not give dosing or medical advice.
Every rate carries its source. Where no source exists, no rate is printed.
| Effect | Rate (sourced) | Detail | Source |
|---|---|---|---|
| Implant-site reactions | not quantified | Most common in the phase 3 trials. | Langendonk et al. 2015 |
| Nausea, headache, oropharyngeal pain | not quantified | Reported more often than placebo. | Langendonk et al. 2015; Scenesse label |
| Darkening of naevi and new naevi | not quantified | Expected pharmacology of MC1R agonism; the label recommends skin examinations. | Scenesse label |
Regulatory status: FDA-approved as Scenesse (2019) for EPP. Research-grade MT1 is not approved for any use.
Afamelanotide is MC1R-selective and has approval data; melanotan II is non-selective, unapproved, and its literature is case reports. That is a real difference in what is known, not proof of safety for research-grade MT1 vials.