Melanotan I

afamelanotide, Scenesse (brand name of the approved implant), [Nle4, D-Phe7]-α-MSH, NDP-MSH, NDP-α-MSH, CUV1647, MT-I, melanotan-1

Longevity & cellular

Awaiting medical reviewEN ES DE FR PT ZH+ Follow for updates

Note on this profile. Afamelanotide is an approved prescription medicine (Scenesse) for a rare genetic light-sensitivity disorder, delivered as an implant inserted by a trained clinician. The lyophilised powder sold online as "Melanotan I" is not that product: its identity, purity and dose are uncontrolled, and injecting it for tanning is unapproved everywhere. This page explains the published science for both contexts.

Summary

Class: Synthetic linear 13-amino-acid analogue of the natural hormone α-MSH, with two substitutions (norleucine at position 4, D-phenylalanine at position 7) that make it more potent and far longer-acting
Mechanism: Activates the MC1R receptor on pigment cells, driving production of eumelanin (the dark, UV-protective pigment) without needing UV exposure; also antioxidant and anti-inflammatory effects in skin
Routes studied: Subcutaneous controlled-release implant (approved); subcutaneous injection (1990s trials; community)
Dose range reported: Approved: one 16 mg implant inserted under the skin every 2 months, ahead of and during periods of increased sunlight exposure. Early trials: 0.08–0.21 mg/kg/day subcutaneous for 10 days (Levine 1991; Dorr 2004). Community (unapproved powder): 0.5–1 mg/day subcutaneous "loading", then 1–2 times weekly
Half-life: ~30 minutes as free peptide in plasma; the implant releases drug over days and the pigment response lasts weeks because melanin turns over slowly †
Storage: Implant: refrigerate 2–8 °C in its sealed vial until insertion. Lyophilised powder: refrigerate, protect from light; reconstituted: refrigerate, community practice within ~4 weeks
Regulatory status: Approved for erythropoietic protoporphyria (EU 2014, US 2019, Australia 2020); all other uses off-label or unapproved; grey-market Melanotan I approved nowhere

Doses are as reported in studies or by the community — never recommendations.

1What it is

α-MSH (alpha-melanocyte-stimulating hormone) is a natural 13-amino-acid hormone cut from the larger protein POMC. It tells skin pigment cells to make melanin and has a of minutes. In 1980 a University of Arizona group (Sawyer, Hruby, Hadley) swapped two amino acids and produced an analogue roughly 10–1,000 times more potent and lasting days rather than minutes. Two drug candidates came out of that work: the linear "Melanotan I" and the cyclic "Melanotan II" (profile 44).

Melanotan I was licensed to the Australian company Clinuvel, which developed it as a slow-release implant for erythropoietic protoporphyria (EPP). EPP is a rare inherited disorder in which a light-sensitive chemical (protoporphyrin IX) builds up in the blood and skin, so that minutes of sunlight cause severe burning pain with no visible rash. Scenesse is the first treatment shown to extend how long people with EPP can be in daylight. Afamelanotide is the international non-proprietary name; "Melanotan I" is now mostly used for the grey-market injectable, which has never been shown to contain the approved molecule at the stated dose.

2How it's thought to work

Pigmentation. MC1R activation raises cyclic AMP in melanocytes, switching on the enzyme tyrosinase and shifting production toward eumelanin, which absorbs and scatters light and quenches free radicals. The tan appears in days without UV.

DNA protection. α-MSH signalling increases repair of UV-induced DNA damage in melanocytes in cell studies (Böhm 2005).

Anti-inflammatory and antioxidant. reduces NF-κB signalling and oxidative stress in skin cells; in EPP the benefit is thought to combine light-shielding by pigment with these protective effects.

Other receptors. compared with Melanotan II it is more selective for MC1R, so it produces fewer brain-mediated effects (erections, appetite loss), though nausea and flushing still occur.

A linear alpha-MSH analogue selective for MC1R. Melanin production rises without the central arm, which is what separates it from the less selective analogues: pigmentation is the intended effect and the appetite and arousal receptors are largely left alone.Schematic — not to scale

3What the research shows

Erythropoietic protoporphyria

Two multicentre (Europe, 74 patients over 180 days; US, 94 patients over 270 days) found that people receiving 16 mg implants every 60 days spent substantially more pain-free time in direct sunlight — in the US trial a median of about 69 hours vs 41 hours over 6 months — had fewer phototoxic reactions and reported better quality of life (Langendonk 2015, NEJM). Long-term observational cohorts (115 Italian and Swiss patients treated up to 8 years; a Dutch real-world cohort) reported sustained benefit and no new safety signals (Biolcati 2015, Br J Dermatol; Wensink 2020, JAMA Dermatol). [4][5][6]

Graded A (small)

Vitiligo (with phototherapy)

In a randomised multicentre trial of 55 adults, afamelanotide implants plus narrowband UVB produced faster and greater repigmentation than UVB alone, especially in darker skin types (Lim 2015, JAMA Dermatol). Not an approved use. [7]

Solar urticaria and polymorphous light eruption

Small open-label studies reported reduced symptoms in solar urticaria (Haylett 2011, Br J Dermatol). Industry Phase 2–3 trials in polymorphous light eruption reported reduced severity but are only partly published †. [8]

Tanning in healthy volunteers

Daily injections for 10 days produced measurable tanning without UV in healthy men (Levine 1991, JAMA; Dorr 2004, Arch Dermatol), with nausea and flushing the main complaints. These 1990s–2000s studies are the only human data behind community tanning use, and they used the pharmaceutical molecule. [2][3]

Graded B/C

Actinic keratosis in transplant recipients, Hailey-Hailey disease, arterial ischaemic stroke, xeroderma pigmentosum

Small pilot or ongoing studies, mostly industry-sponsored; no conclusions yet.

4Reported side effects and interactions

Literature-reported

Literature (Scenesse label and trials). headache (~20%), nausea (~19%), implant-site reactions (~21%: bruising, pain, nodules, occasional expulsion or migration of the implant), nasopharyngitis, back pain, skin hyperpigmentation (~10%), darkening of existing moles and new melanocytic naevi, fatigue, dizziness, flushing, hot flush, irritability. The label recommends a full-body skin examination twice a year and caution in people with a history of melanoma. No melanoma signal has been seen in trials or long-term follow-up, but the number of exposed patients is small.

Community-reported

Community-reported (unapproved powder). nausea (especially the first doses), facial flushing, darkening and multiplication of moles and freckles, uneven or "dirty-looking" tan, reduced appetite, fatigue, injection-site redness. Users often cannot distinguish whether their vial is Melanotan I or II.

Theoretical. stimulating pigment cells in people with many or atypical moles, or a personal history of melanoma, is a genuine concern; darkened moles can also hide early melanoma changes from the person and their doctor. Case reports of melanoma in melanotan users mostly involve grey-market product and sunbed use, so causation cannot be assigned.

Interactions. none established; no formal interaction studies (label).

Markers researchers commonly monitor

Marker	Why it's watched
Full-skin examination with dermoscopy and photographic mole mapping at baseline and twice yearly	the label's main monitoring requirement, because moles darken and new naevi appear.
Pain-free sunlight exposure time and phototoxic reaction diary (EPP context)	the trial endpoints.
Protoporphyrin levels are not expected to change; they track the underlying disease, not the drug
Blood pressure and heart rate	not a signal for afamelanotide, but worth a baseline given the class.
No compound-specific blood markers are established; general baselines (CBC, CMP) only

Free for everyone. Safety information is never behind a paywall.

5Reconstitution and handling

Scenesse is a solid rod inserted by a trained clinician under the skin above the hip; no is involved. Grey-market "Melanotan I" is typically a 10 mg vial, reconstituted with ; the peptide is light-sensitive and should be kept cold and dark.

Open in calculator, pre-loaded →

6Commonly studied alongside

Narrowband UVB (vitiligo trials); standard EPP care (light avoidance, protective clothing); Melanotan II is a comparator, not a partner, in community discussion.

Informational cross-links. Not stack recommendations.

7Regulatory status by region

Region	Status (checked —)
United States	FDA-approved October 2019 (Scenesse) for adults with EPP; administered only by trained healthcare professionals. Injectable "Melanotan I" powders are unapproved drugs; FDA has warned against injectable tanning products
European Union	EMA-authorised December 2014 (Scenesse) for EPP
United Kingdom	MHRA-licensed; NICE recommended afamelanotide for EPP in 2023 †. MHRA has repeatedly warned that injectable melanotans sold online are unlicensed medicines
Australia	TGA-registered 2020 (Scenesse) for EPP †; melanotans otherwise Schedule 4, TGA warns against online purchase
South Africa	Not registered †
Sport (WADA)	Not on the Prohibited List as of review date †

8Open questions

Melanoma risk with decades of use; registries are small.
Adolescents with EPP (trials under way) and other photodermatoses.
Whether grey-market "Melanotan I" contains afamelanotide at all, and at what dose.
Can the pigment-independent protective effects be separated from tanning?

9References

1Sawyer TK et al. (1980). 4-Norleucine, 7-D-phenylalanine-α-melanocyte-stimulating hormone: a highly potent α-melanotropin with ultralong biological activity. Proc Natl Acad Sci USA. PubMed · DOI
2Levine N et al. (1991). Induction of skin tanning by subcutaneous administration of a potent synthetic melanotropin. JAMA. PubMed
3Dorr RT et al. (2004). Increased eumelanin expression and tanning is induced by a superpotent melanotropin [Nle4-D-Phe7]-α-MSH in humans. Photochem Photobiol. PubMed
4Langendonk JG et al. (2015). Afamelanotide for erythropoietic protoporphyria. N Engl J Med. PubMed · DOI
5Biolcati G et al. (2015). Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria. Br J Dermatol. PubMed · DOI
6Wensink D et al. (2020). Association of afamelanotide with improved outcomes in patients with erythropoietic protoporphyria in clinical practice. JAMA Dermatol. PubMed · DOI
7Lim HW et al. (2015). Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. JAMA Dermatol. PubMed · DOI
8Haylett AK et al. (2011). Systemic photoprotection in solar urticaria with α-melanocyte-stimulating hormone analogue [Nle4-D-Phe7]-α-MSH. Br J Dermatol. PubMed · DOI
9Böhm M et al. (2005). α-Melanocyte-stimulating hormone protects from ultraviolet radiation-induced apoptosis and DNA damage. J Biol Chem. PubMed · DOI
10Scenesse (afamelanotide) US prescribing information and EMA summary of product characteristics (current). PubMed

References are being resolved to PubMed/DOI identifiers; links search PubMed for the citation until then.

† Being confirmed by our reviewers against current sources.

10Community

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Self-reported side effects Phase 2

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11Page history

25 Oct 2026Profile published — awaiting medical review

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