An independent peptide reference — no sellers, every claim sourced

Afamelanotide

Also known as Melanotan-1, Melanotan I, MT-1, Scenesse, [Nle4-D-Phe7]-alfa-MSH

Approved alpha-MSH analogue implant for light-induced pain in erythropoietic protoporphyria.

clinically proven Skin & cosmetic approved drug

At a glance

Category
Skin & cosmetic
Status
approved drug
Route
subcutaneous implant (rod), placed above the anterior iliac crest
Half-life
approximately 30 minutes in plasma after release; most of the active substance is released within the first 48 hours and over 90% by day 5, with plasma levels below the limit of quantitation by day 10 in most clinical studies, while the pigment effect persists for weeks. The implant itself is absorbed by the body within 50 to 60 days 4
Onset
Visible increase in pigmentation after approximately 48 hours to a few days; maximum effect after 1-2 weeks
Molecular weight
approximately 1647 g/mol
Sequence
Ac-Ser-Tyr-Ser-Nle-Glu-His-D-Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2

Approved by the EMA in December 2014 and by the FDA in October 2019, under the name Scenesse (implant containing 16 mg afamelanotide as acetate) 14. The indication is narrow: prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP) 4. It is explicitly not approved as a cosmetic tanning agent, and the EU product information restricts prescribing to specialist physicians in recognised porphyria centres, with administration by a physician trained and accredited by the marketing authorisation holder 4. The product remains subject to additional monitoring in the EU 4. Powder sold online as 'melanotan-1' is not a registered product and falls outside any quality control.

Doping status: Not listed by WADA

Checked against the WADA 2026 Prohibited List. For a specific product and country, Global DRO is the lookup athletes are expected to use — the List names substances, not brand names.

Mechanism of action

Afamelanotide is a linear analogue of alpha-melanocyte-stimulating hormone in which methionine at position 4 is replaced by norleucine and phenylalanine at position 7 by its D-form. These two modifications make it resistant to enzymatic degradation and roughly ten times more potent than endogenous alpha-MSH.

It binds predominantly to MC1R on melanocytes. Activation increases, via cyclic AMP and MITF, the production of eumelanin, the dark pigment that absorbs visible light and UV. This occurs independently of exposure to sun or artificial UV light.

In EPP the symptom-causing substance is protoporphyrin IX, which is activated by visible light around 400 nm and generates free radicals. The increased eumelanin absorbs that light in the skin before it reaches the porphyrins. Antioxidant and anti-inflammatory effects of MC1R activation are also presumed to contribute, although their contribution has not been quantified.

Compared with melanotan II, afamelanotide is far more selective for MC1R; it largely lacks the MC3R- and MC4R-mediated effects on appetite, nausea and erection.

What the research shows

For the registered indication the evidence comes from randomised, double-blind, placebo-controlled research, supplemented by long-term observational follow-up in registries. The effect is real but not spectacular: patients can spend longer in the light without pain. Outside EPP there is no evidence, and for cosmetic use there is no long-term safety substantiation whatsoever.

Research in humans

Two multicentre, randomised, double-blind, placebo-controlled studies (74 patients in the EU, 94 in the US) using 16 mg implants every 60 days were published in the New England Journal of Medicine in 2015. Both showed an increase in pain-free exposure to direct sunlight and improved quality of life, with an acceptable side effect profile. A long-running observational study in 115 EPP patients and later registry data from Europe confirm this picture over several years 3.

Animal and lab research

Preclinical research in mice and cell lines confirms MC1R-dependent eumelanin synthesis. These data support the mechanism but play no role in the clinical substantiation.

Caveats. The randomised studies were relatively small and were funded by the manufacturer. The primary endpoint — time spent in direct sunlight without pain — is patient-reported and vulnerable to unblinding, because the visible skin discolouration reveals who received the drug. The absolute difference from placebo was modest in both studies. The EMA granted approval at the time subject to additional conditions for registration and long-term monitoring. There are no data on safety with years of use outside EPP.

What it is used for

  • Prevention of phototoxicity in adult patients with erythropoietic protoporphyria — the only registered indication 4
  • Studied in other photosensitivity disorders, including polymorphic light eruption and solar urticaria, and in vitiligo combined with narrowband UVB — not registered
  • Unregistered cosmetic use as a tanning agent, with powder of unknown origin

Dosing

Dose
One 16 mg implant
Frequency
Every 2 months, usually a maximum of 3-4 implants per year during the brighter season
Route
subcutaneous implant, inserted above the anterior iliac crest
Duration
Recurring treatment, seasonal, for as long as the indication persists
  • These doses come from the official FDA and EMA product information for Scenesse 14, not from user protocols.
  • The implant must be placed by a healthcare professional specifically trained to do so; in the EU it may only be prescribed by specialist physicians in recognised porphyria centres and administered by a physician trained and accredited by the marketing authorisation holder, who is then to observe the patient for 30 minutes for immediate hypersensitivity 4. It is emphatically not self-administered.
  • Among users of grey-market powder, subcutaneous injections of approximately 0.5-1 mg are described. That is not a registered dosing schedule, does not come from clinical research and involves a product without quality control.
  • The product information advises a regular full body skin examination every 6 months, given the pigment change and the need to recognise new or changing lesions early 4. It also advises that the patient's usual sun protection measures be maintained during treatment 4.
  • Afamelanotide has a moderate influence on the ability to drive and use machines, especially within 72 hours of administration, because of reported somnolence, fatigue, dizziness and nausea 4.
  • The grey-market tanning pattern that diverges from the implant — self-injected 'melanotan-1' powder, roughly 0.5-1 mg at a time and often confused with melanotan-II — is set out under Protocols. It has no clinical basis and no quality control.

These figures describe what the literature and published protocols report. They are not advice and not a dosing instruction.

Protocols

Scenesse implant (erythropoietic protoporphyria)

approved product information

Source: SCENESSE (afamelanotide) implant prescribing information, DailyMed

Each administrationa single 16 mg implant inserted subcutaneously above the anterior supra-iliac crest
Intervalevery 2 months, in practice through the brighter part of the year

Inserted by a healthcare professional trained in the procedure; nothing here translates to self-administration, and the grey-market powder sold under the same name bears no relation to this schedule. The product information advises a full skin examination twice a year, because the pigment change makes new or altering lesions harder to notice.

Grey-market 'melanotan-1' tanning use, self-injected (user-reported)

user protocol — not validated

Source: Tanning and bodybuilding forum reports and grey-market vendor labelling

This is not a validated schedule. It is a pattern that circulates among users and sellers, reproduced because it is what people actually follow — not because it has been tested. No trial established these doses, this interval or this duration, and nobody is checking what is in the vial. Treat every number below as an assertion, not a finding.

Reported loading phaseroughly 0.5-1 mg subcutaneously per day until the wanted pigmentation, copied from melanotan-II tanning schedules
Reported maintenancea similar amount once or twice weekly to hold the tan
Reported alongsidedeliberate UV exposure, which the copied schedules claim accelerates the effect

The label directs a single 16 mg controlled-release implant placed by a trained physician every two months for a rare light-sensitivity disease, released over about two days. What circulates is grey-market 'melanotan-1' powder self-injected subcutaneously at roughly 0.5-1 mg for cosmetic tanning — a sixteenth to a thirty-second of the implant content, given as repeated injections with a completely different exposure profile, discarding the controlled release the licensed product is built around. The load-then-maintain schedule is copied wholesale from melanotan-II, the more MC3- and MC4-active analogue that dominates the tanning market, and the two are routinely confused or mislabelled, so a buyer often cannot tell which peptide is in the vial. There is no published basis for cosmetic dosing and no quality control on the powder. The melanocortin concern the label manages with mandatory skin checks — darkening and change in moles and naevi — is unmonitored in self-injectors, and nausea and flushing are commonly reported.

Schedules are reproduced as their source states them. Units, IU and milligrams explains why the figures are not interchangeable between products.

Reconstitution

Vial sizes
implant 16 mg (Scenesse), 10 mg powder (grey market)
Solvent
Not applicable for the registered product: this is a solid implant. Grey-market powder is usually dissolved in bacteriostatic water (0.9% benzyl alcohol)
Storage
Scenesse is stored at 2-8 °C. Grey-market powder: dry and in the freezer, reconstituted at 2-8 °C, protected from light.

Worked example

A 10 mg powder vial with 2 ml bacteriostatic water yields 5 mg/ml; 1 mg then corresponds to 0.2 ml, or 20 units on a U100 insulin syringe.

The calculation examples for powder are descriptive. The registered form is deliberately a controlled-release implant; separate injections give a completely different exposure profile from the one on which the clinical evidence rests. This is also why no syringe calculator is offered here: the 16 mg dose is the entire content of an implant released over about two days, and it is not a quantity anyone draws up or injects. The grey-market injections described above are roughly 0.5-1 mg, which is a sixteenth to a thirty-second of the implant figure.

This is not reconstituted from a powder — it is supplied as a ready-made solution, or as a kit that mixes to a single fixed dose. The vial-and-solvent arithmetic used elsewhere on this site does not apply.

Safety

Side effects

  • Nausea — reported by approximately 19% of treated subjects in the pooled safety data from 425 patients 4
  • Headache — approximately 20% 4
  • Implant site reactions — approximately 21%, mainly discolouration, pain, haematoma and erythema; occasionally migration of the implant 4
  • Fatigue, dizziness, somnolence — dizziness and somnolence are listed as common in the EU product information 4
  • Back pain and abdominal pain — abdominal pain including abdominal discomfort is listed as common 4
  • Skin discolouration and darkening of existing naevi and freckles; ephelides, erythema and pigmentation disorder are listed as common, and melanocytic naevus as common 4. This makes periodic dermatological monitoring necessary
  • Upper respiratory tract infection and influenza — both listed as common 4
  • Hypersensitivity reactions including anaphylaxis — uncommon, but they are the reason the product information requires 30 minutes of observation after implantation 4
  • As with any melanocortin agonism, the effect on existing melanocytic lesions demands attention; unlike melanotan II, this has been followed for afamelanotide within registration research and registries, without an increased melanoma risk being established — but the numbers involved are too small to rule out a rare risk

Do not use if

  • Hypersensitivity to afamelanotide or to any of the excipients — a formal contraindication in the EU product information 4
  • Severe hepatic disease, hepatic impairment and renal impairment — all three are listed as formal contraindications in the EU product information, on the basis that pharmacokinetic data in these populations are simply not available 4
  • Personal history of melanoma or of other skin cancer — requires at minimum very cautious consideration and dermatological assessment
  • Pregnancy and breastfeeding: there are no or limited data in pregnant women and animal studies are insufficient for developmental toxicity; the EU product information states the product should not be used during pregnancy or breastfeeding, and that women of childbearing potential must use effective contraception during treatment and for three months afterwards 4
  • People under 18 years of age: safety and efficacy in children and adolescents up to 17 years have not been established and no data are available 4
  • Elderly patients: use is not recommended because of limited data 4
  • Cosmetic use: there is no substantiation whatsoever that afamelanotide is safe as a tanning agent, and it provides no proven protection against UV damage — sunscreens and limiting exposure remain necessary

Interactions

No specific interaction studies have been performed with this medicinal product, and pharmacokinetic data for afamelanotide and its metabolites are described as very limited; as a short-half-life oligopeptide it is expected to be rapidly hydrolysed to shorter fragments and amino acids, but the product information states that caution is warranted precisely because the data are lacking 4. Patients taking substances that reduce coagulation — vitamin K antagonists such as warfarin, acetylsalicylic acid and NSAIDs — may experience increased bruising or bleeding at the implantation site 4. Combination with other photosensitising drugs has not been studied. Clinically significant gastrointestinal, cardiovascular, respiratory, endocrine, neurological and haematological disorders were not evaluated in the trials, and the product information asks for a careful decision and post-implant monitoring in patients who have them 4.

Sources