Afamelanotide (Melanotan I)
Evidence: A/DDermatology / Cosmetic Research
FDA-approved as the 16 mg Scenesse implant to increase pain-free light exposure in adults with erythropoietic protoporphyria. Cosmetic tanning products marketed as “Melanotan 1” are not established as equivalent to the approved implant.
Quick Summary
FDA-approved as the 16 mg Scenesse implant to increase pain-free light exposure in adults with erythropoietic protoporphyria. Cosmetic tanning products marketed as “Melanotan 1” are not established as equivalent to the approved implant.
Afamelanotide is the canonical name for Melanotan I and is FDA-approved as Scenesse for adults with erythropoietic protoporphyria. Approved implant evidence does not validate unregulated tanning products.
Mechanism & Research Overview
Afamelanotide is the canonical name for Melanotan I and is FDA-approved as Scenesse for adults with erythropoietic protoporphyria. Approved implant evidence does not validate unregulated tanning products.
Research Areas Being Studied
Research areas discussed on this page reflect the Dermatology / Cosmetic Research category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
- Afamelanotide and narrowband UV-B phototherapy for vitiligo (2014):
- Afamelanotide for erythropoietic protoporphyria (2015):
Negative Things to Know
Consideration
The approved implant has route- and product-specific labeling and should not be equated with unregulated injectable tanning products.Consideration
Skin pigmentation changes can complicate monitoring of nevi or other pigmented lesions.Consideration
Evidence for EPP does not establish cosmetic tanning safety or effectiveness.
Study Tables by Evidence Type
Human Studies & Clinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Afamelanotide and narrowband UV-B phototherapy for vitiligo | 2014 | Adults with vitiligo receiving narrowband UV-B with or without afamelanotide | Exploratory indication; does not establish cosmetic tanning use. | ||
| Afamelanotide for erythropoietic protoporphyria | 2015 | Patients with erythropoietic protoporphyria in European and U.S. randomized trials | Pigmentation and implant-site effects were monitored; long-term surveillance remains relevant. |
Animal / Cell / Preclinical Data
No Animal / Cell / Preclinical Data Listed Yet
This section will be updated as sources are added.
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| FDA approval letter for Scenesse (afamelanotide) implant | 2019 | FDA approval record for adults with erythropoietic protoporphyria | Approval is product-, route-, and indication-specific. | ||
| SCENESSE (afamelanotide) current U.S. prescribing information | 2024 | FDA-approved product labeling for adults with EPP | Labeling includes implantation and skin-monitoring considerations; unregulated tanning products are not equivalent. | ||
| Scenesse European public assessment and product information | 2014 | European regulatory assessment for EPP | EU authorization and monitoring are specific to the approved implant and EPP population. |
Study / Trial Dosing
Dosing entries below are limited to what is directly documented in human studies, clinical trials, or official regulatory sources — never a usage recommendation.
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Afamelanotide and narrowband UV-B phototherapy for vitiligo | 2014 | Adults with vitiligo receiving narrowband UV-B with or without afamelanotide | Exploratory indication; does not establish cosmetic tanning use. | ||
| Afamelanotide for erythropoietic protoporphyria | 2015 | Patients with erythropoietic protoporphyria in European and U.S. randomized trials | Pigmentation and implant-site effects were monitored; long-term surveillance remains relevant. | ||
| FDA approval letter for Scenesse (afamelanotide) implant | 2019 | FDA approval record for adults with erythropoietic protoporphyria | Approval is product-, route-, and indication-specific. | ||
| SCENESSE (afamelanotide) current U.S. prescribing information | 2024 | FDA-approved product labeling for adults with EPP | Labeling includes implantation and skin-monitoring considerations; unregulated tanning products are not equivalent. | ||
| Scenesse European public assessment and product information | 2014 | European regulatory assessment for EPP | EU authorization and monitoring are specific to the approved implant and EPP population. |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Educational information only. This page summarizes published and official research and does not provide medical advice, a recommendation, or instructions for human use.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Published. Last updated 2026-07-13.
Get updates when new studies or safety notes are added for this peptide.
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