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Melanotan I: what the studies show, status and safety

Status at a glance

MarketStatusDate
United StatesApproved, prescription only2019-10-08
European UnionApproved, prescription only2014-12-22
GermanyApproved, prescription only2014-12-22
United KingdomApproved, prescription only—
AustraliaScheduled substance—
CanadaApproved, prescription only2026-07-09
SwitzerlandNot approved—
Development stage
Approved
Strongest evidence
Phase 3 randomised trial
WADA status
Not listed
Last verified
2026-09-06
Version
1.0

This page lists no doses.

Melanotan I: what the studies show, status and safety

Summary

Melanotan I and afamelanotide are two names for one peptide, but not for one product. As afamelanotide it is an approved prescription medicine in the European Union, the United States and Canada, for a single rare inherited disease that makes sunlight painful. The approved form is a small implant placed under the skin by trained staff in specialist centres, so every injectable sold as "Melanotan I" is unapproved by definition. In the American licensing trial, patients spent a median of 69.4 hours of pain-free time in direct sunlight over six months, against 40.8 hours on a dummy implant.

Key findings at a glance

  • An approved medicine since 22 December 2014. The European Union cleared it under "exceptional circumstances", a route used when a disease is too rare to gather complete evidence [1]. The United States followed on 8 October 2019 with orphan status, and Canada on 9 July 2026 [2], [3].
  • One approved use, and tanning is not it. The licence covers only the prevention of light-triggered pain in adults with erythropoietic protoporphyria, an inherited disorder of blood pigment production [1], [4].
  • The approved product is an implant, not an injection. A rod of about 1.7 cm is placed under the skin and dissolves over 50 to 60 days. No injectable form of afamelanotide has ever been approved anywhere [4], [5].
  • 69.4 against 40.8 hours of pain-free sunlight. Those were the median totals over 180 days in the 93-patient American trial, a difference the authors reported at p = 0.04 [6].
  • 6.0 against 0.8 hours in the European trial. Over 270 days in 74 patients, with 77 painful light reactions on the drug against 146 on placebo (p = 0.005 and p = 0.04) [6].
  • England never got it. The National Institute for Health and Care Excellence turned it down for the health service on 26 July 2023, judging it too expensive for the benefit shown [7].
  • Regulators are fining grey-market sellers. In Australia one seller of Melanotan II tanning peptide received 27 penalty notices totalling AUD 101,412, paid in May 2026 [8].
  • Not banned in sport, unlike its cousin. Afamelanotide appears nowhere on the 2026 prohibited list. Melanotan II, which is approved nowhere, falls under the ban on non-approved substances [9].

What it is

Melanotan I is a chain of 13 amino acid building blocks, known officially as afamelanotide and in the older research papers as NDP-α-MSH [10]. It is a redesigned copy of alpha-melanocyte-stimulating hormone (α-MSH), the body's own signal that tells pigment cells to make more pigment. Two building blocks were swapped so that enzymes break the molecule down more slowly [5].

Chemists around Victor Hruby and Mac Hadley at the University of Arizona made it first in 1980 [11]. The Australian company Clinuvel Pharmaceuticals developed it into a medicine and holds the approvals; the single brand name of that medicine is SCENESSE [1], [4].

Two lines run through this page. The first separates the names. "Afamelanotide" is the approved medicine, while "Melanotan I" is what unapproved tanning products are called. Same sequence, entirely different products [10], [12].

The second line separates the forms. The licensed product is an implant, and anything in a syringe sits outside the licence [4], [5]. A third name, Melanotan II, is a different molecule altogether.

Quick facts

FieldValueRef
INNAfamelanotide[10]
Also known asMelanotan I, MT-1, NDP-α-MSH, CUV1647[10]
ClassMelanocortin-1 receptor agonist, synthetic α-MSH analogue[4], [5]
Structure13 amino acids, acetylated at one end and amidated at the other[4]
SequenceAc-Ser-Tyr-Ser-Nle-Glu-His-(D)Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2[4]
Formula and massC78H111N21O19, 1,646.85 Da[4], [10]
Half-lifeAbout 30 minutes for the substance itself; about 15 hours as released from the implant[5], [4]
RouteSubcutaneous implant, the only approved form[4], [5]
StatusApproved and prescription-only in the EU, the US and Canada[1], [2], [3]
DeveloperClinuvel Pharmaceuticals Limited, Melbourne[1]
Brand nameSCENESSE[1], [4], [3]
ATC codeD02BB02[5], [13]
CAS registry number75921-69-6[10]
UNIIQW68W3J66U[10]
PubChem CID16197727[10]
InChIKeyUAHFGYDRQSXQEB-LEBBXHLNSA-N[10]
DrugBankDB04931[10]
ChEMBLCHEMBL441738[13]
KEGGD10511[10]
MeSHC534526[13]
WikidataQ410794[13]

Melanotan I: what the studies show, status and safety

How it works

The official product information describes the mechanism as established, because it was studied alongside the licensing trials [5], [4].

  • The MC1R docking point. Afamelanotide latches onto the melanocortin-1 receptor on pigment cells and switches it on. It stays attached longer than the body's own hormone, because the two swapped building blocks protect it from the enzymes that would otherwise take it apart [5], [4].
  • Pigment without sunlight. Switching that receptor on starts the production of eumelanin, the dark form of the pigment, and it does so whether or not the skin sees any sun or sunbed light [5].
  • How eumelanin shields the skin. The product information gives three routes: it absorbs ultraviolet and visible light across a broad range, it mops up reactive molecules, and it helps neutralise a damaging oxygen species [5].
  • Other melanocortin receptors. The literature describes afamelanotide as a melanocortin agonist that prefers MC1R. No formal measurement of how strongly it prefers MC1R over the MC3, MC4 and MC5 receptors appears in the approval documents [5].
  • What the body does with it. Most of the drug leaves the implant within the first 48 hours and more than 90 percent by day five, with blood levels usually below the limit of measurement from day ten [4], [5]. The molecule is thought to be cut into shorter fragments and single amino acids, a process not fully mapped [5].

Two things it is not. It is no sunscreen, and the product information insists that normal sun protection continues throughout treatment [5], [4].

Nor is it the body's own hormone. An older human study found the peptide fully available when injected under the skin, and undetectable in blood after swallowing [14].

What the studies found

The rare disease behind the approval

Erythropoietic protoporphyria is an inherited fault in the making of haem, the iron-carrying part of blood pigment. Roughly one person in 100,000 has it, and afamelanotide is the only approved treatment [15]. Sunlight causes burning pain within minutes, so patients often live indoors by day.

Pain-free time in the sun

Phase 3 RCT The American trial CUV039 enrolled 93 adults with the disease, 48 of whom received afamelanotide and 45 a dummy implant, and followed them for 180 days [4]. Over that period the median total of pain-free hours in direct sunlight between 10 am and 6 pm was 69.4 against 40.8 (p = 0.04) [6]. The published report counts 94 patients as randomly assigned; the regulator's own summary of the same trial gives 64.1 against 40.5 hours, using its stricter definition of the count [4], [6].

CUV039, pain-free hours in direct sunlight over 180 days
Placebo implant
40.8h
Afamelanotide
69.4h

Randomised, double-blind trial in 93 adults with erythropoietic protoporphyria, over 180 days. Figures are median totals of hours spent in direct sunlight between 10 am and 6 pm on days without pain (p = 0.04). Source [6].

Phase 3 RCT The European trial CUV029 ran for 270 days in 74 adults, 38 of them on afamelanotide and 36 on a dummy implant [4]. Its medians look far smaller because it counted a narrower window under stricter conditions: 6.0 hours against 0.8 (p = 0.005) [6].

The regulator's own count of that same figure is 0.75 hours [4]. Painful light reactions numbered 77 against 146 (p = 0.04) [6].

The two sets of hours cannot be added together or compared with each other, because they were counted in different ways.

Everyday use after approval

Prospective cohort, regulator-mandated The European regulator required a study in ordinary care. At one Rotterdam hospital, 117 patients were followed for a median of 2.0 years. Time spent outdoors rose by 6.1 hours per week (95 percent confidence interval 3.62 to 8.67; p < 0.001), and a quality-of-life score improved by 14.01 percent (4.53 to 23.50; p < 0.001) [16].

The same study found light reactions less painful (beta -0.85; -1.43 to -0.26; p < 0.001) but no reliable change in how many happened or how long they lasted [16]. Of the 117 patients, 115 (98 percent) carried on with treatment.

Observational A longer record comes from the porphyria centres in Rome and Zurich, where 115 patients received 1,023 implants over up to eight years. Quality-of-life scores stood at 31 ± 24 percent of the maximum before treatment, rose to 74 percent and stayed there [17].

Three of those patients felt their hopes were not met. Another 23 percent stopped for unrelated reasons such as pregnancy or cost [17].

Vitiligo, tested but not approved

Phase 1/2 RCT, open-label In vitiligo, the skin loses pigment in patches. A trial in 55 adults compared afamelanotide plus narrowband ultraviolet B light (28 patients) against the light treatment alone (27 patients). The combination was already ahead by day 56 (p < 0.05). By day 168 it had repigmented 48.64 percent of affected skin (95 percent confidence interval 39.49 to 57.80) against 33.26 percent (24.18 to 42.33) [18].

Colour returned sooner on the face (41.0 against 61.0 days; p = 0.001) and the upper limbs (46.0 against 69.0 days; p = 0.003). The advantage was clearer in darker skin types and absent in the lightest type included [18]. A larger phase 3 trial in 200 patients has finished recruiting; no country has approved this use [19].

The early tanning studies

Phase 1 RCT, 1991 The reason the peptide has a second life on the internet lies in a study published 35 years ago. Twenty-eight healthy men received ten injections over twelve days under medical supervision, with strong sunscreen throughout. Skin darkened measurably in both skin-type groups (p < 0.001) and not at all on placebo [20].

Small open-label study, 2000 Seven volunteers received ten daily injections, and skin samples were analysed afterwards. A week after the last dose the marker for eumelanin had risen by 49 ± 17.6 percent in forehead skin (p = 0.019, three participants), and by 98 ± 25.4 percent in forearm skin (p = 0.003, seven participants).

The marker for the lighter pigment did not change measurably.

In the forearm the ratio of dark to light pigment moved from 51:1 to 86:1 (p = 0.054), a difference the authors could not separate from chance [21].

Both studies show that the molecule does what it is meant to do. Neither says anything about long-term safety, and neither used material of unknown origin bought online [22].

Antibodies and vitamin D

Laboratory analysis Blood from 26 patients exposed for up to six years was tested for antibodies against the drug. Twenty-three showed no immune reaction at all. Three had a pre-existing reaction against both afamelanotide and the natural hormone, and their levels did not change during treatment [23].

Observational A two-centre study looked at vitamin D in this patient group, where 47 to 63 percent are deficient and brittle bones are common. It examined the effects of both vitamin D supplements and afamelanotide on those levels [24].

What is still unknown

  • Anything beyond two years. Safety has not been studied in trials running longer than that [5].
  • Whether the pigment changes matter in the long run. No cancer studies in animals were done, and the drug darkens existing moles and freckles, which is why skin checks are required [4], [5].
  • How the body handles it in illness. The effect of kidney or liver problems on the drug is unknown, no interaction studies were run, and dose-finding studies were never performed [5].
  • Common conditions were left out. Heart, lung, gut, hormonal, neurological and blood disorders were not evaluated in the trial programme [5].
  • What is in grey-market material. Nothing is known about the purity, content or sterility of anything sold as "Melanotan I", because no such product has been tested by a regulator [12].

Side effects and safety

The American safety database covers 244 adults from three placebo-controlled trials, 125 of whom received the drug and 119 a dummy implant. That is a wide base for an ultra-rare disease and a small one by ordinary medicine standards [4]. The European figures pool 425 patients [5].

EventAfamelanotidePlacebo
Implant-site reactions21%10%
Nausea19%14%
Throat pain7%5%
Cough6%3%
Fatigue6%3%
Skin darkening4%0%
Dizziness4%3%
New or changed mole4%2%
Respiratory infection4%3%
Drowsiness2%1%
Non-acute porphyria2%0%
Skin irritation2%0%

Headache is listed separately in the European information as very common, at about 20 percent [5]. What the labels warn about:

  • Twice-yearly skin checks are required. The drug darkens the whole skin as well as existing moles and freckles. The European information gives two reasons for a full-body examination every six months. Patients treated for this disease are likely to go out in the sun far more than before. And changes in pigmented spots must be caught early [4], [5].
  • Extra caution with a melanoma history. That covers melanoma in the patient or the family, and known inherited risk such as the familial atypical mole and melanoma syndrome. Past basal cell, squamous cell or Merkel cell cancer counts too [5].
  • Severe allergic reactions, including anaphylaxis, have been reported since launch. Treatment is then stopped for good and the implant removed if needed [4], [5].
  • Who must not have it. Anyone with a known severe reaction to the drug; the European information adds severe liver disease, impaired liver function and impaired kidney function [4], [5].
  • Sun protection continues. Usual measures stay in place throughout treatment [4], [5].
  • Not for everyone. It should not be used above the age of 70, because the data are thin, nor in pregnancy or breastfeeding. Effective contraception is required during treatment and for three months afterwards [5].
  • Driving. The European information rates the effect on driving as moderate, particularly in the first 72 hours, because of drowsiness, tiredness, dizziness and nausea [5].
  • No boxed warning. A full check of the American label found none. The strongest warnings there concern hypersensitivity and skin monitoring [4].

Case reports involving products sold as Melanotan I. These are single published cases about unapproved material, not findings from the licensed medicine. One man with a melanoma history grew a crop of new and partly atypical moles after injecting a synthetic α-MSH peptide himself. Existing moles darkened, then settled again once he stopped [25].

Other published cases describe:

  • new atypical moles within a week of two injections [26];
  • a dark band running along a nail [27];
  • a painful prolonged erection treated in hospital [28];
  • a skin ulcer disorder at the injection sites [29];
  • melanoma and melanoma in situ in users [30], [31].

A 2017 review counted four melanomas arising in existing moles during or shortly after use. It stated plainly that causation is not proven [22].

Case reports involving Melanotan II are a separate matter. Muscle breakdown with a stimulant-like picture, and a kidney infarction, have been reported after self-injection of that different, ring-shaped peptide [32], [33]. Those findings belong to Melanotan II and must not be carried over to afamelanotide, or the reverse.

Two further risks belong to the syringe, not the molecule. The Australian regulator warns about serious infection from self-injection, and the British regulator has pointed to blood-borne viruses passed on through shared needles [12], [34].

Why this page lists no doses

Afamelanotide is prescription-only everywhere it is approved, and controlled more tightly than most medicines. Only specialists at recognised porphyria centres may prescribe it. Only staff trained and accredited by the licence holder may place the implant [5], [7]. Choosing and giving it is a matter for those doctors, not for a reference page.

The same applies from the other direction. Products sold as "Melanotan I" have no verified content at all, so any number attached to them would describe nothing [8], [35].

Development and approval status

From laboratory to licence

  1. 1980NDP-α-MSH is synthesised at the University of ArizonaWorking group of Victor Hruby and Mac Hadley, ref [11]
  2. 1991First controlled human study of skin darkening without ultraviolet light28 healthy men, ref [20]
  3. 22 Dec 2014European Union approval under exceptional circumstancesEU/1/14/969/001, ref [1]
  4. 2015The two licensing trials appear in the New England Journal of MedicineCUV039 and CUV029, 167 patients in total, ref [6]
  5. 8 Oct 2019United States approval with orphan statusNDA 210797, priority review, ref [2]
  6. 26 Jul 2023England: NICE recommends against use in the health serviceHST27, never launched in England, ref [7]
  7. 9 Jul 2026Canadian approval recordedDIN 02569825, not yet marketed, ref [3]
  • 1980 — the molecule is first made at the University of Arizona [11].
  • 1991 and 2000 — small studies in healthy volunteers show skin darkening and a measurable rise in eumelanin [20], [21].
  • 2014 — the European Union approves it on 22 December under exceptional circumstances, with an orphan designation granted back in 2008 [1].
  • 2015 — the two licensing trials are published together [6].
  • 2019 — the American regulator approves it on 8 October as a new molecular entity, with priority review and orphan status [2].
  • 2023 — England's cost-effectiveness body recommends against it on 26 July, and the product is never launched there [7].
  • 2026 — Canada records approval on 9 July, with no marketing date yet [3].
MarketStatusSince or note
European UnionApproved2014-12-22
GermanyApproved2014-12-22
United StatesApproved2019-10-08
CanadaApproved2026-07-09
United KingdomAuthorisedNot launched
AustraliaPrescription-onlySchedule 4
SwitzerlandNot approved—

Every entry reflects the position on 6 September 2026. The European approval carries conditions most medicines do not: a compulsory disease register, a training programme for doctors, and a controlled access scheme supplying trained centres only [5].

In the United Kingdom the licence exists, but the medicine was never launched in England. No product information was listed in the national compendium on 6 September 2026 [7], [36].

Australia is the market most often misread. The substance sits in Schedule 4 of the poisons standard, prescription-only, and the index cross-references that entry directly to "MELANOTAN I" [37]. Tanning products under that name are therefore unlawful to supply, not legal.

The Australian regulator seized illegal melanotan products in January 2026. It then issued 27 penalty notices totalling AUD 101,412 against one seller of Melanotan II, paid in May 2026 [38], [8].

Switzerland has no approval at all, although the substance was supplied there for years under a compassionate-use scheme before the European licence [39]. Germany is covered by the European approval, which applies directly. The German supply and reimbursement position could not be confirmed from an official source.

The wider framework is set out under are peptides legal and FDA-approved peptides.

Anti-doping

Afamelanotide is not on the 2026 prohibited list, nor on the monitoring programme, and a full-text search of the official document returned nothing for "afamelanot", "melanotan" or "melanocort" [9]. It also escapes class S0, which bans "any pharmacological substance ... with no current approval by any governmental regulatory health authority for human therapeutic use", precisely because it is approved [9].

Melanotan II is the opposite case. It is approved nowhere, so it falls under S0 and is banned at all times [9], [40]. The catch is that a vial of unknown origin labelled "Melanotan I" could hold either substance, or neither.

The list is rewritten every year, so athletes should check the current version with their national body. The wider picture is at peptides banned in sport.

Compared with related peptides

PeptideActs onStatusStrongest human result in its own study
Melanotan I (afamelanotide)MC1R preferredApproved in the EU, US and Canada69.4 against 40.8 median pain-free hours over 180 days, CUV039, n = 93 [6]
Melanotan IIMelanocortin receptors, non-selectiveApproved nowhereErection without sexual stimulation in 17 of 20 men [41]
BremelanotideMelanocortin receptorsApproved in the US since 21 June 2019Approved for low sexual desire in premenopausal women [42]
α-MSHMC1R and related receptorsThe body's own hormone, not a medicineReference point rather than a treatment [5]
KPVFragment of α-MSH, positions 11 to 13Approved nowhereNo approved use; assessed by the FDA compounding committee in 2026 [43], [44]

The row for each peptide reads differently, and that is the point. Melanotan I is a straight chain, while Melanotan II is a shorter ring of seven building blocks with its own formula and registry number. That lack of selectivity is what produced the erections and nausea seen in its human studies [40], [41].

Bremelanotide grew out of Melanotan II as its breakdown product, was developed under the code PT-141 and became an approved medicine for a completely different purpose [42], [45]. KPV is simply the last three building blocks of the natural hormone [43]. Only Melanotan I has ever been approved as a medicine, and only for one rare disease.

Common misconceptions

  • "Melanotan I is that tanning peptide from the internet." The sequence is the same, the product is not. The approved medicine is a sterile implant with checked content, made for one rare disease and placed by trained staff. Grey-market material has no verified content, purity or origin [12], [35].
  • "An implant and an injection amount to the same thing." They do not. The implant releases the drug over days and dissolves in 50 to 60 days. That is why the labels quote about 15 hours as the apparent half-life, against roughly 30 minutes for the substance itself. Neither figure carries over to a syringe [4], [5].
  • "Melanotan I, Melanotan II and PT-141 are versions of one thing." Three different molecules. One is approved for a rare light disease, one is approved nowhere, and the third is approved for low sexual desire. Their side-effect reports must be kept apart [40], [42].
  • "It is legal in Australia." The substance is prescription-only there, and the poisons standard cross-references "MELANOTAN I" to that entry. Importing it without a prescription from an Australian doctor is unlawful, and advertising it to the public, influencers included, is not allowed [37], [12], [46].
  • "There must be a boxed warning." There is none. A full check of the American label found no boxed warning; the prominent warnings concern severe allergic reactions and skin monitoring [4].
  • "A tan from it replaces sun cream." Both labels require normal sun protection to continue. The Australian regulator puts it bluntly: no tan, fake or real, protects skin against damage from sun exposure [4], [5], [46].

Frequently asked questions

Is Melanotan I the same as afamelanotide?

Chemically, yes: both names describe the same 13-building-block peptide, and the chemical databases list them as synonyms of one entry. As products they are not the same at all. "Afamelanotide" refers to an approved implant with checked content and a licence; "Melanotan I" is what unapproved tanning preparations of unknown origin are called.

Is Melanotan I approved as a medicine?

Yes, as afamelanotide, and only for one purpose. The European Union approved it on 22 December 2014, the United States on 8 October 2019 and Canada on 9 July 2026. The licence covers the prevention of light-triggered pain in adults with erythropoietic protoporphyria. No country has approved it for tanning.

What did the Melanotan I trials actually measure?

Hours of pain in the sun, not appearance. In the American trial of 93 patients the median total of pain-free hours in direct sunlight over 180 days was 69.4 against 40.8 on a dummy implant (p = 0.04). In the European trial of 74 patients over 270 days it was 6.0 against 0.8 hours (p = 0.005), with 77 painful reactions against 146.

Why is injectable Melanotan I never an approved product?

Because the only approved form is an implant. A small rod is placed under the skin by trained staff and dissolves over 50 to 60 days. No medicines agency anywhere has approved an afamelanotide solution for injection, so any injectable sold under the name falls outside every licence by definition.

What is the difference between Melanotan I and Melanotan II?

They are two different molecules. Melanotan I is a straight chain of 13 building blocks and prefers the MC1R docking point. Melanotan II is a ring of seven, with a different formula and registry number, and acts on melanocortin receptors without preference. That lack of selectivity explains the erections and nausea reported in its human studies.

What are the side effects of Melanotan I in the approved trials?

Reactions where the implant sits affected 21 percent of patients against 10 percent on placebo, and nausea 19 percent against 14 percent. Headache is listed as very common in Europe, at about 20 percent. Severe allergic reactions including anaphylaxis have been reported since launch, and a full-body skin examination is required twice a year.

Does Melanotan I have a boxed warning?

No. A full check of the American product label found no boxed warning of any kind. The warnings printed there concern severe hypersensitivity reactions and the need for regular skin monitoring, because the drug darkens existing moles and freckles as well as the skin overall.

No, not as a tanning product. The active substance is listed as prescription-only in Schedule 4 of the poisons standard, and the index cross-references it to "MELANOTAN I". Importing it without a prescription from an Australian doctor is unlawful, and advertising it to the public is prohibited. In 2026 one seller of Melanotan II paid AUD 101,412 in penalties.

Is Melanotan I banned in sport?

Afamelanotide is not on the 2026 prohibited list and not on the monitoring programme. It escapes the ban on non-approved substances precisely because it is an approved medicine. Melanotan II is caught by that ban, and a product of unknown origin could contain either, so the label on the vial settles nothing.

What is still unknown about Melanotan I?

Safety beyond two years has not been studied in trials. No animal cancer studies were carried out, and the drug darkens moles, which is why regular skin checks are required. The effect of liver or kidney problems on the drug is unknown, no interaction studies were run, and nothing at all is known about what unapproved products contain.

Sources

  1. European Medicines Agency. EPAR: Scenesse (afamelanotide). Marketing authorisation EU/1/14/969/001, authorised 22 December 2014 under exceptional circumstances; holder Clinuvel Europe Limited, Dublin. Retrieved 6 September 2026. https://www.ema.europa.eu/en/medicines/human/EPAR/scenesse
  2. Drugs@FDA / openFDA, NDA 210797 (SCENESSE): original approval 8 October 2019, submission class Type 1 new molecular entity, priority review, orphan property; labelling supplement approved 12 August 2024. Retrieved 6 September 2026. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22afamelanotide%22 and https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210797Orig1s000ltr.pdf
  3. Health Canada, Drug Product Database: SCENESSE, DIN 02569825, drug code 107203, status Approved with status date 9 July 2026, schedule Prescription, no original market date recorded. Retrieved 6 September 2026. https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=107203
  4. SCENESSE (afamelanotide) implant, for subcutaneous use — US Prescribing Information. Clinuvel Inc., revision 08/2024. NDA 210797. DailyMed setid 94f53286-11dd-7fbb-e053-2a95a90a7c48. Full label check confirmed the absence of a boxed warning. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94f53286-11dd-7fbb-e053-2a95a90a7c48
  5. European Medicines Agency, Scenesse — product information (Annex I summary of product characteristics, Annex II, Annex III), revision 13, updated 21 October 2025. Sections 4.1, 4.3 to 4.8, 5.1, 5.2, 6.1 to 6.5 and Annex II section B and E. https://www.ema.europa.eu/en/documents/product-information/scenesse-epar-product-information_en.pdf
  6. Langendonk JG, Balwani M, Anderson KE et al. (2015). Afamelanotide for erythropoietic protoporphyria. New England Journal of Medicine 373(1):48-59. PMID 26132941. DOI 10.1056/NEJMoa1411481. Reports both licensing trials, CUV039 (NCT01605136, 180 days) and CUV029 (NCT00979745, 270 days).
  7. National Institute for Health and Care Excellence. Highly specialised technologies guidance HST27: afamelanotide for treating erythropoietic protoporphyria. Published 26 July 2023. Chapters 1 and 3. https://www.nice.org.uk/guidance/hst27
  8. Therapeutic Goods Administration (Australia). Safety alert: Melanotan II tanning peptide products found to be inconsistently dosed, August 2026. Seized nasal sprays contained between 22 mg and 54 mg per bottle against a single declared amount; 27 infringement notices totalling AUD 101,412, paid in May 2026. https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/melanotan-ii-tanning-peptide-products-found-be-inconsistently-dosed
  9. World Anti-Doping Agency, Prohibited List 2026, in force from 1 January 2026. Full-text check of the official document on 6 September 2026 returned no match for afamelanotide, melanotan or melanocortin, in either the list or the monitoring programme. Wording of class S0 quoted. https://www.wada-ama.org/en/prohibited-list
  10. PubChem, compound CID 16197727 (afamelanotide). National Library of Medicine. Formula C78H111N21O19, molecular weight 1,646.8, CAS 75921-69-6, UNII QW68W3J66U, DrugBank DB04931, KEGG D10511; the synonym list includes Melanotan I, Melanotan-1, MT-1 and NDP-alpha-MSH. Retrieved 6 September 2026. https://pubchem.ncbi.nlm.nih.gov/compound/16197727
  11. Minder EI, Barman-Aksoezen J, Schneider-Yin X (2017). Pharmacokinetics and pharmacodynamics of afamelanotide and its clinical use in treating dermatologic disorders. Clinical Pharmacokinetics 56(8):815-823. PMID 28063031. DOI 10.1007/s40262-016-0501-5. Records the 1980 synthesis at the University of Arizona.
  12. Therapeutic Goods Administration (Australia). Melanotan — illegal therapeutic goods. Names both Melanotan I and Melanotan II; not listed in the Australian Register of Therapeutic Goods, not assessed for quality, safety or efficacy, treated as prescription-only medicines; import for personal use requires a prescription from a doctor registered in Australia; warns of infection risk from self-injection. https://www.tga.gov.au/melanotan-illegal-therapeutic-goods
  13. Wikidata, Q410794 (afamelanotide): CAS 75921-69-6, UNII QW68W3J66U, ATC D02BB02, ChEMBL CHEMBL441738, MeSH C534526, ChEBI 136034. https://www.wikidata.org/wiki/Q410794
  14. Ugwu SO, Blanchard J, Dorr RT, Levine N et al. (1997). Skin pigmentation and pharmacokinetics of melanotan-I in humans. Biopharmaceutics and Drug Disposition 18(3):259-269. PMID 9113347. Complete bioavailability after subcutaneous injection; no measurable plasma levels after oral dosing.
  15. Dechant C, Wäscher S, Granata F, Gusset N et al. (2025). New pharmacotherapies for the erythropoietic protoporphyrias: an analysis of trial protocols from a patient perspective. Orphanet Journal of Rare Diseases 20(1):637. PMID 41466311. Prevalence of about 1 in 100,000; afamelanotide as the only approved therapy.
  16. Wensink D, Wagenmakers MAEM, Barman-Aksözen J, Friesema ECH et al. (2020). Association of afamelanotide with improved outcomes in patients with erythropoietic protoporphyria in clinical practice. JAMA Dermatology 156(5):570-575. PMID 32186677. Post-authorisation cohort study required by the European regulator, 117 patients at Erasmus MC Rotterdam.
  17. Biolcati G, Marchesini E, Sorge F, Barbieri L et al. (2015). Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria. British Journal of Dermatology 172(6):1601-1612. PMID 25494545. DOI 10.1111/bjd.13598. 1,023 implants over up to eight years at the porphyria centres in Rome and Zurich.
  18. Lim HW, Grimes PE, Agbai O et al. (2015). Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. JAMA Dermatology 151(1):42-50. PMID 25230094. DOI 10.1001/jamadermatol.2014.1875.
  19. ClinicalTrials.gov, registry query for afamelanotide, 6 September 2026: 23 registered studies, including NCT06109649, a phase 3 trial of the implant with narrowband UV-B against narrowband UV-B alone in 200 patients with non-segmental vitiligo, active and no longer recruiting. https://clinicaltrials.gov/
  20. Levine N, Sheftel SN, Eytan T et al. (1991). Induction of skin tanning by subcutaneous administration of a potent synthetic melanotropin. JAMA 266(19):2730-2736. PMID 1658407. Randomised, placebo-controlled, double-blind study in 28 healthy men.
  21. Dorr RT, Dvorakova K, Brooks C et al. (2000). Increased eumelanin expression and tanning is induced by a superpotent melanotropin Nle4-D-Phe7-alpha-MSH in humans. Photochemistry and Photobiology 72(4):526-532. PMID 11045725.
  22. Habbema L, Halk AB, Neumann M, Bergman W (2017). Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review. International Journal of Dermatology 56(10):975-980. PMID 28266027. DOI 10.1111/ijd.13585. Four reported melanomas arising in existing moles; causation not proven.
  23. Lengweiler S, Kreim S, Barman-Aksözen J, Maurer M et al. (2015). Evaluation of the immunogenicity of the synthetic alpha-MSH analogue afamelanotide in erythropoietic protoporphyria patients by ELISA. Skin Pharmacology and Physiology 28(2):103-113. PMID 25402764. DOI 10.1159/000362174.
  24. Kluijver LG, Nekouei Shahraki M, Wagenmakers MAEM, Hanssen BE et al. (2024). The effects of cholecalciferol and afamelanotide on vitamin D levels in erythropoietic protoporphyria: a multicentre cohort study. British Journal of Dermatology 191(3):357-364. PMID 38634774. DOI 10.1093/bjd/ljae148.
  25. Cardones AR, Grichnik JM (2009). Alpha-melanocyte-stimulating hormone-induced eruptive nevi. Archives of Dermatology 145(4):441-444. PMID 19380666. DOI 10.1001/archdermatol.2008.623.
  26. Reid C, Fitzgerald T, Fabre A, Kirby B (2013). Atypical melanocytic naevi following melanotan injection. Irish Medical Journal 106(5):148-149. PMID 23914578.
  27. Paurobally D, El Hayderi L, Richert B, André J et al. (2013). Melanotan-associated transverse melanonychia. Journal of the European Academy of Dermatology and Venereology 27(1):128-129. PMID 22182016. DOI 10.1111/j.1468-3083.2011.04399.x.
  28. Dreyer BA, Amer T, Fraser M (2019). Melanotan-induced priapism: a hard-earned tan. BMJ Case Reports 12(2). PMID 30796078.
  29. Dickson D, Hlaing Htwe S (2025). Pyoderma gangrenosum secondary to melanotan. Cureus 17(12):e98297. PMID 41487785. DOI 10.7759/cureus.98297.
  30. Paurobally D, Jason F, Dezfoulian B, Nikkels AF (2011). Melanotan-associated melanoma. British Journal of Dermatology 164(6):1403-1405. PMID 21564053. DOI 10.1111/j.1365-2133.2011.10273.x.
  31. Ong S, Bowling J (2012). Melanotan-associated melanoma in situ. Australasian Journal of Dermatology 53(4):301-302. PMID 22724573. DOI 10.1111/j.1440-0960.2012.00915.x.
  32. Nelson ME, Bryant SM, Aks SE (2012). Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clinical Toxicology (Philadelphia) 50(10):1169-1173. PMID 23121206. DOI 10.3109/15563650.2012.740637.
  33. Peters B, Hadimeri H, Wahlberg R, Afghahi H (2020). Melanotan II: a possible cause of renal infarction — review of the literature and case report. CEN Case Reports 9(2):159-161. PMID 31953620.
  34. Langan EA, Nie Z, Rhodes LE (2010). Melanotropic peptides: more than just 'Barbie drugs' and 'sun-tan jabs'? British Journal of Dermatology 163(3):451-455. PMID 20545686. DOI 10.1111/j.1365-2133.2010.09891.x. Cited here as the secondary source for the British regulator's warning about blood-borne viruses and product contamination; the original press release was not retrievable on 6 September 2026.
  35. Breindahl T, Evans-Brown M, Hindersson P et al. (2015). Identification and characterization by LC-UV-MS/MS of melanotan II skin-tanning products sold illegally on the internet. Drug Testing and Analysis 7(2):164-172. PMID 24771717. DOI 10.1002/dta.1655. Vials contained 4.32 to 8.84 mg against a declared 10 mg, with unknown impurities of 4.1 to 5.9 percent.
  36. UK electronic medicines compendium, search for 'scenesse' on 6 September 2026: no summary of product characteristics listed, consistent with the absence of a launch in England. https://www.medicines.org.uk/emc/search?q=scenesse
  37. Therapeutic Goods (Poisons Standard — June 2026) Instrument 2026, authorised version F2026L00633, registered 28 May 2026. Schedule 4 entry AFAMELANOTIDE; index entry 'AFAMELANOTIDE — cross reference: MELANOCYTE STIMULATING HORMONE, MELANOTAN I — Schedule 4'; separate Schedule 4 entry for MELANOTAN II.
  38. Therapeutic Goods Administration (Australia). Media releases: Illegal melanotan products seized (January 2026) and Individual issued 27 infringement notices for allegedly supplying Melanotan II (June 2026). https://www.tga.gov.au/news/media-releases/illegal-melanotan-products-seized
  39. Swissmedic, list of authorised human medicine packs, data extract evaluated 6 September 2026: no entry for afamelanotide or Scenesse. Context on the earlier Swiss compassionate-use supply from Minder EI, Schneider-Yin X (2015), Expert Review of Clinical Pharmacology 8(1):43-53, PMID 25470471.
  40. PubChem, compound CID 92432 (Melanotan II). Formula C50H69N15O9, molecular weight 1,024.2, CAS 121062-08-6, UNII UPF5CJ93X7; cyclic structure Ac-Nle-cycloAsp-His-D-Phe-Arg-Trp-Lys-NH2. https://pubchem.ncbi.nlm.nih.gov/compound/92432
  41. Wessells H, Levine N, Hadley ME et al. (2000). Melanocortin receptor agonists, penile erection, and sexual motivation: human studies with Melanotan II. International Journal of Impotence Research 12 Suppl 4:S74-S79. PMID 11035391. DOI 10.1038/sj.ijir.3900582.
  42. openFDA Drugs@FDA, NDA 210557 (VYLEESI, bremelanotide): original approval 21 June 2019, submission class Type 1 new molecular entity, UNII PV2WI7495P. Retrieved 6 September 2026. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bremelanotide%22
  43. PubChem, compound CID 125672 (KPV, Lys-Pro-Val). Formula C16H30N4O4, molecular weight 342.43, CAS 67727-97-3; the C-terminal tripeptide of alpha-MSH, positions 11 to 13. https://pubchem.ncbi.nlm.nih.gov/compound/125672
  44. US Food and Drug Administration (2026). Briefing document, Pharmacy Compounding Advisory Committee meeting, 23-24 July 2026; KPV assessed with no unique ingredient identifier assigned and no approved medicinal use. https://www.fda.gov/media/193342/download
  45. Hadley ME, Dorr RT (2006). Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization. Peptides 27(4):921-930. PMID 16412534. DOI 10.1016/j.peptides.2005.01.029. Development history of Melanotan I, Melanotan II and PT-141 (bremelanotide).
  46. Therapeutic Goods Administration (Australia). Don't risk using tanning products containing melanotan. Blog post, February 2025. 'Melanotan is not approved for sale or use as a tanning agent in Australia'; 'No tan, fake or real, will protect skin against damage from sun exposure'; restrictions apply to any form and to advertising including by social media influencers. https://www.tga.gov.au/news/blog/dont-risk-using-tanning-products-containing-melanotan

Cite this page

The facts on this page were checked on 6 September 2026, and the official registers behind the status table were queried on that same day. Approved medicines pick up new warnings and new markets over time, so the version and the date matter as much as the text.

myPeptides Research & Editing. (2026). Melanotan I: what the studies show, status and safety. Version 1.0, 6 September 2026. myPeptides Peptide Register. Retrieved from https://mypep.app/peptides/melanotan-i

How pages in this register are compiled and graded is described under methodology; the full register is at peptides.

VersionDateChange
1.02026-09-06Initial publication

Last verified: 6 September 2026. Next review: on a labelling change in any covered market, on publication of the phase 3 vitiligo trial, or on any change in the anti-doping classification.

Identifiers

IdentifierValue
CAS number75921-69-6
PubChem CID16197727
UNIIQW68W3J66U
InChIKeyUAHFGYDRQSXQEB-LEBBXHLNSA-N
DrugBankDB04931
ChEMBLCHEMBL441738
WikidataQ410794
Molecular formulaC78H111N21O19
Molecular weight1646.85
SequenceAc-Ser-Tyr-Ser-Nle-Glu-His-(D)Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2

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Cite this page

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myPeptides Research & Editing (2026). Melanotan I: what the studies show, status and safety (Version 1.0). myPeptides. https://mypep.app/peptides/melanotan-i

Machine-readable version (JSON)

Last reviewed: September 2026

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