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Skin & hair

Afamelanotide

Melanotan I · MT-1 · Scenesse (brand) · Nle4-D-Phe7-α-MSH

ApprovedReviewed 16 Aug 2026

Afamelanotide is melanotan I, the compound melanotan II was derived from. It is an analogue of alpha-MSH — the hormone that tells pigment cells to make melanin — and it darkens skin by the mechanism its name suggests.

What makes it worth a page of its own is that it is approved. The FDA approved it in 2019, and the EMA in 2014, as Scenesse, for erythropoietic protoporphyria, a rare inherited disorder in which sunlight causes severe burning pain within minutes. Increasing melanin gives those patients usable time outdoors, and the trials measured exactly that: hours of pain-free light exposure.

It is delivered as a 16 mg implant, roughly the size of a grain of rice, inserted under the skin by a clinician every two months. That delivery method is not incidental. It exists because sustained, controlled release was what the clinical programme required, and it is one of several reasons the approved product and the injectable powder sold as 'melanotan 1' are not the same proposition. Set the two melanotans side by side and the difference is not the molecule. One went through the process. The other did not.

How it works

Afamelanotide is a selective agonist at the melanocortin 1 receptor on melanocytes. Activating MC1R drives production of eumelanin, the darker and more photoprotective form of melanin, which absorbs and dissipates ultraviolet energy before it damages the cell.

It is far more selective for MC1R than melanotan II is. That selectivity is why it produces pigmentation without melanotan II's nausea, flushing and sexual effects. Those come from MC4R activity in the brain, which afamelanotide largely avoids.

In erythropoietic protoporphyria the problem is a build-up of protoporphyrin IX, which reacts with light to damage tissue and cause pain. More melanin means less light reaching it. The drug does not treat the metabolic defect; it reduces the light exposure that triggers the symptom.

It is structurally a single-residue-substituted alpha-MSH: norleucine at position 4 and D-phenylalanine at position 7, both changes made to resist enzymatic breakdown rather than to alter what the molecule does.

Regulatory status — United States and European Union

Approved by the FDA (2019) and the EMA (2014) as Scenesse, a 16 mg subcutaneous implant for erythropoietic protoporphyria, inserted by a trained clinician every two months. Not approved for cosmetic tanning anywhere. Injectable powder sold as melanotan 1 is a research chemical — not the approved product — and does not share its delivery method, purity controls or supervision.

Last reviewed 16 Aug 2026. Regulatory positions in this category change frequently; we date this line so you can see how current it is.

What it is studied for

Each entry states the evidence behind it. We do not rank indications by effectiveness — for most compounds here, that would be a claim nobody can support.

Erythropoietic protoporphyria

Clinical trial

The approved indication: increasing pain-free sunlight exposure.

EvidenceTwo randomised, double-blind, placebo-controlled trials found significantly more pain-free time in direct sunlight. Approved by both the FDA and the EMA.

Cosmetic tanning

Community practice

Why it is bought as a research chemical.

EvidenceIt does produce pigmentation, which is not in question. No trial has assessed the safety of using it for this purpose, and the approval does not extend to it.

Vitiligo, in combination with phototherapy

Clinical trial

Studied, not approved.

EvidenceA randomised trial in combination with narrowband UVB reported greater repigmentation than phototherapy alone. Not sufficient for approval in this indication.

Identity and clearance

Molecule

Class
Linear tridecapeptide, selective MC1R agonist
Molecular weight
1646.8 Da
Length
13 amino acids

Sequence

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

Considerably larger than melanotan II, which is a cyclic heptapeptide. The two are relatives rather than variants.

Pharmacokinetics

Clinical trial
Half-life24 h
Substantially cleared5 d
100%50%25%0%half-life 24hdose30h2.5d3.8d5d
Modelled from the half-life above, assuming first-order elimination. Illustrative rather than measured — it shows the shape of clearance, not a prediction for any individual.

The approved implant releases over about two months, so the peptide's own half-life is not what governs the dosing interval. Injected preparations behave completely differently.

Dose protocols reported in sources

Displayed for reference only. Every row says where it came from, and a trial protocol and a community convention are not the same kind of information. None of this is fed into the calculator, and none of it is a recommendation.

Dose protocols reported in sources, with the source of each.
GoalDoseFrequencyRouteUnits, 10 mg vialSourceStart this protocol
Approved regimen for erythropoietic protoporphyria16 mgOne implant every two monthsSubcutaneousA 16 mg bioresorbable implant placed above the hip by a trained clinician, releasing over roughly two months. Not an injection, and not something the approved product is designed for a patient to administer.Over one vialClinical trialStart this
Commonly described community protocol for injectable powder500 mcg – 1 mgDaily during a loading phase, then weeklySubcutaneousInjectable melanotan 1 is dosed on a completely different basis from the approved implant, because the delivery is completely different. Comparing the two dose figures is meaningless, and the community figures rest on no trial at all.10–20 uCommunity practiceStart this

Start this copies a row into a protocol of your own, which you can then edit. Where a source gave a dose range or an ambiguous frequency, those fields arrive empty — we will not pick a number on your behalf.

CheckRows marked community practice describe what people commonly do, drawn from public discussion. They are not derived from any trial and are not evidence that a dose is safe or effective.

Calculator

Work out what to draw

Pre-filled with a 10 mg vial as a worked example. These are not recommended values — change them to match the vial in front of you.

Dose unit
Your syringe
010203040506070809010010 units0.1 mL

Draw to 10 units on a 1 mL U-100 syringe. That is 0.1 mL, containing 500 mcg of Afamelanotide.

Concentration5mg / mL
Volume drawn0.1mL
Doses per vial20doses
Per unit50mcg / unit

10 units sits exactly on a printed line.

Bioalmanac performs arithmetic on values you enter. It does not recommend doses, schedules or compounds, and nothing here is medical advice. Confirm every calculation against your vial and syringe before drawing, and speak with a licensed healthcare provider.

Open this calculation in the full calculator

Units, concentration, bacteriostatic water — the glossary defines the vocabulary, and a unit is not a fixed volume.

Safety

Reported effects

  • NauseaClinical trial

    Common in trials

    Substantially milder than with melanotan II, reflecting the greater MC1R selectivity.

  • HeadacheClinical trial

    Common in trials

  • Implant site reactionsClinical trial

    Common in trials

    Specific to the approved delivery method rather than to the peptide.

  • Darkening of existing moles and frecklesClinical trial

    Expected from the mechanism

    Melanocyte stimulation acts on existing pigmented lesions too. The approved product's labelling requires twice-yearly full-skin examination for exactly this reason. A monitoring requirement, not a warning to be waved past.

  • FatigueClinical trial

    Reported in trials

When to stop

  • Any mole that changes in size, shape, colour or border, or that bleeds or itches. See a dermatologist promptly.
  • Any new pigmented lesion.
  • Any allergic response: rash, hives, facial swelling or difficulty breathing. Seek urgent care.
  • Persistent nausea or headache that does not settle.
  • An implant site that becomes hot, spreading or produces pus.

Interactions and situations that need care

  • Melanoma history, atypical mole syndrome, or many molesAvoid

    The compound stimulates melanocytes, the cells melanoma arises from. The approved product's labelling mandates twice-yearly full-skin examination even in supervised use for a serious indication, which tells you how the regulator weighs this. None of that monitoring exists when the same mechanism is used cosmetically.

  • Severe liver or kidney impairmentAvoid

    Excluded from the clinical trials, so there is no data on clearance or accumulation in these patients. The approved labelling reflects that exclusion.

  • Pregnancy and breastfeedingAvoid

    No reproductive or developmental safety data.

  • Treating it as sun protectionUse caution

    It increases melanin, which reduces but does not eliminate UV damage. In the approved indication it is used precisely so patients can tolerate light they otherwise cannot. The concern that they then get more UV exposure is real, and it is why skin monitoring is part of the labelling.

What to expect

  • It is approved, and the approval is narrow: a rare light-sensitivity disorder, an implant, a clinician, twice-yearly skin checks.
  • Injectable powder sold as melanotan 1 is not the approved product. It shares the sequence, and not the delivery, the purity controls or the supervision that the trial results depend on.
  • It is meaningfully cleaner than melanotan II, with far less nausea and none of the sexual or appetite effects, because it is selective for the pigmentation receptor.
  • The melanocyte concern does not go away with selectivity. A regulator that approved this drug still requires full-skin examination twice a year.
  • Pigmentation takes one to two weeks to develop and fades over months.

Storage and handling

Freeze-dried powder
Refrigerated at 2–8 °C, protected from light.
After mixing
Refrigerated at 2–8 °C. Do not freeze once mixed.
Long-term, frozen
Unopened powder is stable at −20 °C or colder.

Printable one-pagerHow to reconstitute a vial, step by step

With other peptides

  • Both act on melanocortin receptors and both drive pigmentation. Combining them stacks melanocyte stimulation for no additional effect, and adds melanotan II's nausea, blood pressure and MC4R effects to a compound that avoids them.

  • PT-141caution

    The same receptor family, with different selectivity: afamelanotide favours MC1R, PT-141 MC4R. Running both means stimulating the whole family. This is what melanotan II already does and is not obviously desirable.

Check this against a whole stack

Checking your vial

Research chemicals carry no manufacturing standard, so what the vial looks like is often the only quality signal available before you use it. More on assessing quality and COAs.

  • White cake, clear solution

    Standard for a lyophilised linear peptide.

  • Collapsed cake, or any colour in the solution

    A tanning peptide does not produce a coloured solution. Colour means degradation or contamination.

Questions

Is this the same as melanotan II?
No. They are relatives. Afamelanotide is melanotan I, a 13-residue linear peptide selective for the pigmentation receptor. Melanotan II is a 7-residue cyclic peptide that hits the whole melanocortin family. Afamelanotide is approved for a rare disease; melanotan II is approved nowhere and carries the stronger side-effect profile.
If it is approved, is injecting it for a tan safe?
The approval covers a 16 mg implant placed by a clinician every two months, for a serious light-sensitivity disorder, with mandatory twice-yearly skin examination. Injecting a research chemical for cosmetic tanning shares the molecule and none of the rest. The melanocyte-stimulation concern applies either way, and in the cosmetic case nobody is checking your skin.
What is erythropoietic protoporphyria?
A rare inherited disorder in which a light-reactive compound builds up in the skin, so that minutes of sunlight cause severe burning pain. Afamelanotide increases melanin and gives patients meaningfully more time outdoors. The trials measured hours of pain-free sun exposure directly.
Does it protect against sunburn?
It reduces UV damage without eliminating it, and it is not a substitute for sunscreen. People consistently overestimate how much sun darker skin lets them tolerate.

References

  1. Afamelanotide for erythropoietic protoporphyria: randomised controlled trials supporting approval

    New England Journal of Medicine, 2015 · Two randomised, double-blind, placebo-controlled trials

    Adults with erythropoietic protoporphyria · n = 168 · 16 mg subcutaneous implant, every two months · 180 days and 270 days

    Significantly more pain-free time in direct sunlight than placebo. Nausea and headache were the most common adverse events. Supported FDA and EMA approval, with labelling requiring twice-yearly full-skin examination.

    10.1056/NEJMoa1411481

  2. Afamelanotide with narrowband UVB phototherapy in generalised vitiligo

    JAMA Dermatology, 2015 · Randomised controlled trial

    Adults with generalised vitiligo · n = 55 · 16 mg implant monthly with narrowband UVB · 6 months

    Greater and faster repigmentation than phototherapy alone, with the difference most pronounced in patients with darker skin. Not approved for this indication.

  3. Commonly reported community protocols

    Bioalmanac editorial summary of public community sources, 2026 · Not a study

    Records loading and maintenance dose patterns described for injectable melanotan 1. These bear no relation to the approved implant regimen and carry no evidential weight about safety or effect.

Keep this page honest

If something here is wrong, out of date, or missing a source, tell us and we will fix it and say that we did.

Suggest a correction

This page is educational. It describes what published research reports, not what you should do. Peptides discussed here are largely not approved for human use, and nothing on Bioalmanac is medical advice. No clinician reviews these pages.

Page last updated 16 Aug 2026