The Approved Melanotan

Afamelanotide

Also known as Melanotan I · Scenesse

Prescription · work with your prescriberSummary coverage

At a glance

What it is: Melanotan I is an approved implant for a rare disease. Melanotan II is not.

Evidence: Clinical trialsHow the tiers workApproved for erythropoietic protoporphyria only, on trial evidence measuring hours spent outdoors between 10am and 3pm on pain-free days over 270 days: a median of 6 hours against 0.75 hours on placebo. Why this tier

Half-life: Not established in available literature
Routes: Implant
Category: Skin
FDA: FDA-approved; As of 3 August 2026. What that means
WADA: We do not state a status
Amino acids: 13

Putting Afamelanotide on a schedule, with the vial it comes from and a log of each dose, happens in the app: Claritide for iPhone.

Evidence

Why this tier

Approved for erythropoietic protoporphyria only, on trial evidence measuring hours spent outdoors between 10am and 3pm on pain-free days over 270 days: a median of 6 hours against 0.75 hours on placebo. Cosmetic tanning use is off-label and unstudied. The half-life and the full adverse-event table could not be verified, since the regulator’s PDF documents returned errors, so we publish neither.

Overview

What it is

Afamelanotide, sold as Scenesse, was FDA-approved on 8 October 2019 to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria. It is delivered as a 16 mg implant inserted subcutaneously by a trained healthcare professional every two months. This record exists mainly as a disambiguator: Melanotan I is an approved drug for a rare disease, Melanotan II is not approved for anything.

Mechanism

How it works

Afamelanotide is a synthetic thirteen-amino-acid analogue of alpha-melanocyte-stimulating hormone and an MC1R agonist. It stimulates production of eumelanin in the epidermis independently of ultraviolet exposure. In erythropoietic protoporphyria, where accumulated protoporphyrin makes skin painfully photosensitive, more eumelanin means more absorbed light before pain begins. The mechanism is the same MC1R pathway that gives Melanotan II its tanning effect; the difference is selectivity, formulation, oversight and a trial programme.

Dosing

Commonly researched ranges

These are figures reported in published literature and practitioner protocols: a commonly researched range, not a recommendation. Claritide does not tell you what to take.

Label dose (Scenesse)16 mg
One implant every 2 months
A single implant inserted subcutaneously above the anterior supra-iliac crest by a trained healthcare professional. This is not a self-administered product.

Phase	Amount	Frequency	Timing	Note
Label dose (Scenesse)	16 mg	One implant every 2 months	Not established in available literature	A single implant inserted subcutaneously above the anterior supra-iliac crest by a trained healthcare professional. This is not a self-administered product.

Cycle guidance: The label regimen is one implant every two months, administered by a clinician.
Goals: Skin & hair

Legal standing

Where this sits with the FDA

Dated, sourced, and separate from whether it works. Removal from a warning list is not permission to compound.

FDA-approvedas of 3 August 2026 · US

FDA-approved drug product (Scenesse)

Approved for erythropoietic protoporphyria, a rare inherited photosensitivity disorder. Cosmetic tanning is not an approved use. The label recommends a full-body skin examination twice a year, because the drug induces skin darkening and changes to pigmented lesions need to stay visible against that background.

Last change · 8 October 2019 · FDA approved afamelanotide to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria.

Primary source

Sport

WADA status

The 2026 Prohibited List entered force on 1 January 2026.

We do not state a status

Not named on the 2026 Prohibited List. Afamelanotide holds a US marketing authorisation, so the S0 catch-all does not obviously capture it. We could not determine a classification and do not state one.

We looked and could not resolve it. This is not the same as "not prohibited". Treat it as unresolved and check with your federation before competing.

Reconstitution

There is nothing to mix

Not applicable. None of the published routes for this compound take a diluent, so there is no concentration to calculate and no beyond-use window to track.

Expectations

Week by week

What our material describes people reporting. Individual responses vary widely.

Not established in available literature.

Tolerability

Side effects

Grouped by how often our sources report them. Percentages appear only where a published trial figure exists.

Common

Skin darkeningExpected from the mechanism, and named on the label. The label recommends a full-body skin examination twice a year.

Safety

Contraindications and interactions

Do not use if

Not established in available literature.

Interactions

Not established in available literature.

Absence from this list does NOT mean safety. It means lack of research.

Handling

Storage and cost

Storage: A manufactured implant handled by a healthcare professional. There is no reconstitution, concentration or beyond-use window for a user to track.
Cost: Not established in available literature

Combinations

Stacks with

Only pairings our own material actually documents. Stacking is the least evidence-based part of this field.

Melanotan IIThe Tanning Peptide

Deep dive

Afamelanotide in full

Limited coverage: a disambiguator

Melanotan I and Melanotan II are different compounds with completely different standing.

Melanotan I is afamelanotide, sold as Scenesse, and it is FDA-approved, since 8 October 2019, to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria, a rare inherited disorder in which accumulated protoporphyrin makes skin painfully photosensitive.

Melanotan II is not approved for anything, is illegal to sell and supply in the UK, and carries a case-report literature of melanoma and severe systemic toxicity.

Users conflate them constantly, and vendor pages do nothing to discourage it.

The approved product

A synthetic thirteen-amino-acid alpha-MSH analogue and MC1R agonist that stimulates epidermal eumelanin production without ultraviolet exposure. Delivered as a single 16 mg implant inserted subcutaneously above the anterior supra-iliac crest, every two months, by a trained healthcare professional.

That delivery route is why our data model needed an implant option at all, and it is worth noting what it means: this is not a product anyone self-administers.

What the trial measured

Hours spent outdoors between 10am and 3pm on pain-free days over 270 days: a median of 6 hours against 0.75 hours on placebo. That is a functional endpoint about being able to go outside, which is a fair description of what the disease takes away.

The label recommends a full-body skin examination twice a year, because the drug induces skin darkening and any change in a pigmented lesion has to stay visible against that background.

Half-life and the full adverse-event table could not be verified, since the regulator's PDF documents returned errors during our checking, so we publish neither.

References

Sources

1
Scenesse (afamelanotide) implant · US prescribing information, DailyMed
Source

Every record in this library is free to read, and it stays free. Your own schedule, vials and log live in the app: Claritide for iPhone.