Melanotan I (Afamelanotide): Evidence, Side Effects, and Regulatory Status (2026)
Melanotan I (Afamelanotide) is FDA-approved (Scenesse). Evidence grade: strong. This page is clinically reviewed.
TL;DR / Quick Facts
Melanotan I (Afamelanotide) is Melanotan I (afamelanotide) is a selective MC1R agonist FDA-approved as Scenesse (implant) for erythropoietic protoporphyria (EPP). Tanning is a side effect; not the labeled use. FDA status: FDA-approved (Scenesse). Typical use cases: tanning, skin. Evidence grade: strong. Dosing is per the FDA label — set by your clinician. Common side effects: see below. Medriva editorial stance: follow the FDA label; do not use off-label without clinical supervision.
What it is
Melanotan I (Afamelanotide) is a member of the MC1R selective agonist class. Afamelanotide binds MC1R on melanocytes, increasing eumelanin production. Approved in EPP for photoprotection; tanning is a downstream effect.
What the evidence says
Evidence for Melanotan I (Afamelanotide) is strong. Multiple phase 3 trials and post-market data support the labeled indications.
[Detailed evidence breakdown in the corresponding claim or pillar pages is linked at the bottom of this page.]
What it's used for
Commonly discussed uses of Melanotan I (Afamelanotide):
- Tanning — strong evidence.
- Additional uses listed in the linked use-case hubs; evidence varies by indication.
For the full list, see the linked use-case hubs below.
Typical dosing
Melanotan I dosing is determined by the approved label, indication, comorbidities, current medications, and clinician judgment. Medriva does not publish individualized dosing instructions or titration schedules. Review the current prescribing information and make changes only with a licensed clinician.
Side effects and risks
- Common: Side effects vary by compound and indication; review the approved label or profile-specific safety data with a clinician.
- Serious: Seek urgent care for severe allergic symptoms, chest pain, severe abdominal pain, persistent vomiting, or other severe reactions.
- Long-term unknowns: For non-approved or research-use compounds, long-term human safety data may be limited.
Regulatory status
- FDA-approved use(s): Scenesse (EPP).
- Compounded availability: see 503A vs 503B explainer
- Research-use-only (RUO) availability: n/a
- Banned in sport: see WADA & sports explainer
Cost and access
Melanotan I (Afamelanotide) is available by prescription; see the cost page for the relevant indication. For pricing, see our cost pages or the GLP-1 price/supply tracker where applicable.
Who it might be appropriate for
Adults with a relevant diagnosed condition or clinical goal, under the supervision of a licensed clinician, who have no contraindications. Melanotan I (Afamelanotide) is not for self-experimentation.
Who should not use it
Contraindications vary by compound, indication, pregnancy status, comorbidities, and current medications. For the full list, see the contraindications checklist and discuss with your clinician.
Medriva editorial stance
We describe the literature. We do not promote Melanotan I (Afamelanotide) as a cure, treatment, or performance enhancer. We do not recommend it for self-experimentation. We do recommend that readers (a) understand the evidence grade (strong), (b) understand the regulatory status (FDA-approved (Scenesse)), and (c) discuss with a licensed clinician before acting.
How to talk to a clinician
See our guide on how to talk to a clinician for a templated conversation.
Frequently Asked Questions
Is Melanotan I (Afamelanotide) FDA-approved?
FDA-approved (Scenesse). See the regulatory status section above for details.
Does Melanotan I (Afamelanotide) work for tanning?
Evidence is strong. See the linked use-case hub for the full breakdown.
What are the side effects?
See the side effects section above. Discuss with your clinician.
How much does Melanotan I (Afamelanotide) cost?
See the cost pages or the GLP-1 price/supply tracker where applicable.
Can I buy Melanotan I (Afamelanotide) online?
By prescription only. Medriva does not sell peptides.
Author + Clinical reviewer
Author: Sara Iqbal, MS Clinical reviewer: Jonathan Reeves, MD Last reviewed: 2026-06-05
Next steps
- Review the evidence grade and regulatory status before making decisions about Melanotan I.
- Bring this page to a licensed clinician if you are discussing benefits, risks, or alternatives.
- Subscribe to the Medriva Peptide Brief for evidence and regulatory updates.
Related use-case hubs
Related comparisons
Editorial process
This page follows the Medriva Editorial Policy and the Clinical Review Methodology. Page last reviewed: 2026-06-05. Author: Sara Iqbal, MS. Clinical reviewer: Jonathan Reeves, MD.
Current source updates
For new regulator actions, compounding-policy changes, warning letters, shortage updates, and sports-rule changes, review the Peptide Tracker before relying on older summaries.
