What does Melanotan I do?

Melanotan I refers to afamelanotide, a synthetic 13-amino-acid analog of alpha-MSH. As Scenesse, it has regulatory approval for adults with erythropoietic protoporphyria to increase pain-free light exposure. The source distinguishes this clinician-administered implant use from cosmetic tanning use.

How does Melanotan I work?

Afamelanotide activates MC1R on melanocytes. That receptor signaling increases eumelanin, a darker melanin associated with photoprotection. The source attributes its longer and stronger activity versus native alpha-MSH to norleucine at position 4 and D-phenylalanine at position 7, and notes it is more MC1R-selective than Melanotan II.

Is Melanotan I FDA approved?

Yes. The source reports FDA approval in 2019 for erythropoietic protoporphyria and EMA approval in 2014. The approval described is for Scenesse/afamelanotide in EPP, not for general tanning.

What are the side effects of Melanotan I?

The reported effects include nausea, intended skin darkening, headache, fatigue and reactions at the administration site. The research summary characterizes adverse events in pivotal EPP trials as mostly mild, while also warning that unregulated injectable Melanotan products are not equivalent to the approved implant.

What is the typical dose of Melanotan I?

The source provides two different dosing contexts. Community-reported use is 500-1000 mcg daily during loading, then 500-1000 mcg 1-2 times weekly for maintenance, with a 250-1000 mcg per-injection range. The research/approved-label row reports a 16 mg subcutaneous implant. These should be reviewed as separate contexts rather than combined into one recommendation.

Skin & Hair FDA Approved - approved for specific uses

Melanotan I

Also known as: Afamelanotide, Scenesse, MT-1, CUV1647, [Nle4, D-Phe7]-alpha-MSH, NDP-MSH

At a glance

PeptiGuide dataset · reviewed Aug 2026

What it is

FDA-approved afamelanotide analog researched for EPP-related photoprotection

Status

FDA Approved

Evidence level: human clinical evidence

Typical dose

500–1,000mcg

Subcutaneous implant

Researched for

Skin tanning, photoprotection, sun sensitivity disorders

Trial progress

PrePreclinical
IPhase I
IIPhase II
IIIPhase III
IVPhase IV
FDAFDA approved

FDA approved - FDA-approved for specific uses with established human evidence

Use the tools

In plain language

Melanotan I is afamelanotide, a 13-amino-acid synthetic alpha-MSH analog also identified as [Nle4, D-Phe7]-alpha-MSH or NDP-MSH.
Scenesse/afamelanotide is reported as EMA-approved in 2014 and FDA-approved in 2019 for erythropoietic protoporphyria.
Approved-label dosing is a 16 mg implant; the source separately reports community injection dosing of 500-1000 mcg daily during loading and 500-1000 mcg 1-2x weekly for maintenance.
Researched areas include skin tanning, photoprotection and sun-sensitivity disorders, with explicit caution that approval is specific to EPP.

How it's thought to work

Afamelanotide is described as an MC1R acting on melanocytes. Activation of this melanocortin receptor promotes eumelanin production, which the source connects with photoprotection in EPP. The analog differs from native alpha-MSH at positions 4 and 7, changes reported to improve receptor binding and metabolic stability. The source also states that, compared with Melanotan II, Melanotan I is not primarily framed as an appetite or sexual-function because of its relative MC1R selectivity.

What the research shows

Where the research stands

The source describes human clinical evidence in erythropoietic protoporphyria, including two multicenter randomized, double-blind, placebo-controlled trials reported in 2015 by Langendonk et al. in the New England Journal of Medicine. Across EU and US sites, 168 people with EPP received either a 16 mg implant or placebo every 60 days. Reported outcomes included longer pain-free sunlight exposure, fewer phototoxic reactions and better disease-specific quality-of-life measures; the US trial example cited median pain-free sunlight time of 69.4 hours versus 40.8 hours. Long-term observational data are described as supporting ongoing benefit with an acceptable safety profile. The source emphasizes that the approval is limited to EPP and that unregulated injectable Melanotan products are not the controlled clinician-administered implant.

What it shows

✓ Human clinical evidence

FDA-approved for specific uses with established human evidence

△ Limitations

Use only according to approved labeling and qualified medical guidance.

Bottom line: FDA Approved (2019) - Erythropoietic Protoporphyria FDA Approved (2019) for erythropoietic protoporphyria

Typical dosing

CommunityCommunity dataset

500–1,000 mcg

daily (loading), then 500-1000 mcg 1-2x weekly (maintenance)

250 mcgfull range seen1,000 mcg

Community-reported regimen. The source also notes subcutaneous injection-like use compared with MT-II, greater selectivity than MT-II, fewer sexual side effects, and slower tanning onset than MT-II. This row is not the approved Scenesse implant regimen. · Injected subcutaneously like MT-II

Research dosing

Indication-specificApproved for specific uses - study doses are indication-specific

Doses observed in studies

16 mg subcutaneous implant

FDA Approved Labeling - Scenesse prescribing information

Use only according to approved labeling and qualified medical guidance.

Duration: Long-term / as needed before sun season
Administration: Subcutaneous implant (not injection)

Timing & administration

Best time to take

Evening or before sun exposure

Daily during loading, then maintenance doses

Food recommendation

With or without food

Why this timing?

The source links evening timing with less noticeable flushing and timing before sun exposure with the intended tanning or photoprotection-related effect. This timing information comes from community-style use and should be reviewed separately from the approved implant schedule.

Possible side effects

Not everyone experiences these. Individual responses vary with dose, duration, and personal factors.

Nausea
Skin darkening
Headache
Fatigue
Injection site reactions
Known safety-profile context in FDA-approved use

Not everyone experiences side effects, and severity can vary by context, purity, route, and individual health factors.

Sources

PubMed ClinicalTrials.gov FDA.gov

Frequently asked questions

Sequence

Ac-Ser-Tyr-Ser-Nle-Glu-His-D-Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2

One open dataset

Every fact on this page - doses, side effects, references - comes from the same PeptiGuide dataset that powers the Tracker, Compare, and the Lab.

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Educational resource, not medical advice. Talk to your clinician before acting on anything here.

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Melanotan I

In plain languageIn plain language

How it's thought to workHow it's thought to work

What the research showsWhat the research shows

Typical dosing

Research dosing

Timing & administrationTiming & administration

Possible side effectsPossible side effects

SourcesSources

Frequently asked questionsFrequently asked questions