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Strong evidence · Grade A

Melanotan 1

Melanotan 1 (Afamelanotide)
Score
82 / 100
Delivery
SC injection
Brand
Scenesse
FDA
2019
TL;DR
01
Afamelanotide (Scenesse) is an FDA-approved melanocortin (MC1R) agonist — the pigmentation-selective, regulated member of the 'melanotan' family.
02
It is approved for one rare condition: preventing phototoxicity in adults with erythropoietic protoporphyria (EPP), a genetic disorder that makes sunlight excruciating.
03
In phase 3 trials it significantly increased the pain-free time EPP patients could spend in sunlight, which is the basis for its approval.
04
It is delivered as a controlled-release implant by a clinician every ~60 days — not a self-injected grey-market product like Melanotan 2.
05
Expected skin darkening is part of its mechanism; because it stimulates pigment cells, dermatologic monitoring of moles is standard.
Pain-free sun time (EPP)
Increased
phase 3 · significant vs placebo
Approved use
EPP phototoxicity
only indication
Delivery
16 mg implant
subcutaneous, every 60 days
Vitiligo
Investigational
repigmentation with NB-UVB
Approvals
FDA + EMA
2019 / 2014
Part 01 · How it works

Mechanism.

Afamelanotide is a stabilized version of alpha-MSH that selectively activates MC1R, the receptor that tells skin to make eumelanin — the brown-black pigment that shields against light. In people with erythropoietic protoporphyria, whose skin reacts painfully to light, boosting this natural pigment defense lets them tolerate more sunlight before pain sets in. Unlike Melanotan 2, it is targeted at pigmentation (not broad melanocortin activation), and it is delivered as a medical implant under clinician supervision.

It turns up the skin's own built-in sunscreen — the melanin defense — on a slow-release medical implant, rather than the scattershot, self-injected approach of the grey-market melanotans.

MC1R agonism
Selectively activates melanocortin-1 receptors on melanocytes, driving photoprotective eumelanin synthesis.
Stabilized α-MSH
Nle4-D-Phe7 substitutions resist enzymatic breakdown, extending duration versus native α-MSH.
Controlled-release implant
A 16 mg subcutaneous implant delivers sustained exposure over ~60 days, administered by a healthcare provider.
Photoprotection
Increases the skin's tolerance to visible light/UV, reducing phototoxic pain episodes in EPP.
Part 02 · Dosing & administration

How it's taken.

Community-reported · unregulated

Values below reflect commonly reported community protocols for Melanotan 1. These are anecdotal and unregulated — not clinically validated and not a recommendation. Provided for educational purposes only — this is not medical advice and not instructions for self-administration. Consult your healthcare provider before making any health decision.

Wk 1–4
250–500 mcg
Loading — 2× weekly (some protocols daily); pair with brief, gradually increasing UV exposure
TARGET
Wk 5+
250 mcg
Maintenance — 1–2× weekly to hold pigmentation
·
Community injectable figures are anecdotal and extrapolated from clinical implant data — not validated instructions.
·
The FDA-approved form is the Scenesse implant (16 mg / 60 days, clinician-placed) for EPP; injectable Melanotan I is research-grade and unapproved.
·
Selective for MC1R (vs Melanotan II) — slower tanning, fewer systemic effects; any new or changing moles warrant dermatologic review before use.
Need help with reconstitution?

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Part 03 · Safety

Side effects, rare serious events, who shouldn't.

Common
Nausea
Generally mild, transient.
Common
Headache / nasopharyngitis
Reported in trials.
Common
Implant-site reactions
Pain or redness at the implant site.
Common
Skin darkening
Inherent to the mechanism (increased melanin).
Expected
Serious · rare
Darkening/change of nevi
Dermatologic monitoring recommended; report changing moles.
Monitored
Hypersensitivity
Discontinue for serious allergic reaction.
Rare
Absolute · do not use
×
History of melanoma or atypical mole syndrome
×
Pregnancy or breastfeeding
×
Children under 18
×
Known hypersensitivity to afamelanotide or any component
×
Personal or family history of skin cancer
Relative · discuss first
!
History of melanoma or atypical mole syndrome — caution/monitoring
!
Pregnancy or breastfeeding — insufficient data
!
Hepatic or renal impairment — clinician judgment
!
Seeking cosmetic tanning — not an approved use
Interactions
Photosensitizing drugs (tetracyclines, fluoroquinolones)
May increase risk of phototoxic reactions due to enhanced melanogenesis and sun exposure behavior
Moderate
Immunosuppressants
Melanocortin signaling has immunomodulatory effects; theoretical interaction with immunosuppressive therapy
Moderate
Other melanocortin agonists (Melanotan II, PT-141)
Additive melanocortin receptor activation; increased risk of adverse effects
Moderate
Labs to monitor
Dermatological Exam (Full Body Skin Check)
Baseline and every 6 months
Monitor moles and nevi for changes with increased melanin production
CBC with Differential
Baseline and every 6 months
General safety monitoring
CMP (Comprehensive Metabolic Panel)
Baseline and every 6 months
Liver and kidney function
Vitamin D, 25-OH
Baseline and annually
Increased melanin may affect vitamin D synthesis
Part 04 · Evidence

How strong is the evidence?

82
Grade A
Grade A within its indication. Randomized phase 3 trials, FDA and EMA approval, and years of registry use support afamelanotide for EPP phototoxicity. The limits are scope (approved only for EPP), the need for pigment/mole monitoring, and that benefit requires continued implants.
Mechanistic plausibility
Directly amplifies the skin's own photoprotective pigment pathway via MC1R.
88
Human evidence
Randomized phase 3 trials (EPP) and a vitiligo RCT; FDA + EMA approved with post-marketing data.
85
Safety & tolerability
Generally well tolerated; nausea/headache and expected skin darkening; nevi monitoring recommended.
78
Durability
Benefit maintained with repeated implants; reverses once treatment stops.
74
Independence
Industry-sponsored pivotal trials, corroborated by independent registry and vitiligo research.
78
Part 05 · Research log

Every study we cite.

We list each study with its methodology, funding source, and our quality grade. Flagged studies aren't dismissed — they're tagged so you can weigh them.

01
2015
New England Journal of Medicine Industry funded
Afamelanotide for erythropoietic protoporphyria — phase 3
Significantly increased the pain-free time EPP patients could spend in direct sunlight versus placebo — the pivotal basis for approval.
Randomized, placebo-controlled phase 3 · Sponsor-funded pivotal trial; rare-disease population.
PMID 26132941 ↗
High
02
2015
JAMA Dermatology Industry funded
Afamelanotide + narrowband UV-B for vitiligo — RCT
Combination produced superior repigmentation vs NB-UVB alone, especially on face and upper extremities (investigational use).
Randomized multicenter trial · Investigational vitiligo use, not the approved indication.
PMID 25230094 ↗
Moderate
03
2021
Expert Rev Clin Pharmacol Flagged
Afamelanotide for prevention of phototoxicity in EPP (real-world review)
Real-world effectiveness appears strong and may exceed trial results; authors note the fixed 60-day dosing interval leaves some patients under-treated.
Narrative review incl. post-marketing data · Narrative review; the real-world superiority is clinical impression, not a controlled comparison.
PMID 33507118 ↗
Moderate (review)
Evidence against

What didn't work, and where the evidence is thin.

Every publication is incentivized to tell you a peptide works. We catalogue the null results, failed trials, and mechanism limits we found in the same literature — so you can weigh them against the upside, with your provider.

01
Benefit is indication-specific and reverses when stopped
Discontinuation effect
Expert Rev Clin Pharmacol · 2021
The evidence supports afamelanotide for EPP phototoxicity; photoprotection depends on ongoing implants and there is no approval for cosmetic tanning or anti-aging. The grey-market use of 'melanotan' for tanning is a different, unapproved practice.
What this means: Afamelanotide is a regulated therapy for a rare disease, not a tanning product. Using melanocortin agonists for cosmetic tanning falls outside this evidence entirely.
PMID 33507118 ↗
02
Stimulates pigment cells — nevi monitoring required
Safety signal
NEJM (phase 3) · 2015
Because it drives melanogenesis, pre-existing moles can darken, and dermatologic monitoring is recommended during treatment. Long-term melanoma risk has been studied without a clear increase, but surveillance remains standard.
What this means: Even the approved, selective melanocortin agonist warrants skin surveillance — underscoring why unmonitored grey-market melanocortin use is riskier still.
PMID 26132941 ↗
Part 06 · Cost & access

Where it's available, at what price.

United States
FDA-approved
Rx as Scenesse for EPP via specialist centers under a restricted program; clinician-administered implant. Not approved for tanning.
Specialty pricing; covered for the approved EPP indication
European Union
Approved
EMA-approved (2014) as Scenesse for EPP; specialist administration.
Specialty pricing
United Kingdom
Approved (restricted)
Available for EPP through specialist services.
Specialist-funded
Canada
Approved
Approved for EPP; specialist administration.
Specialty pricing
The Peptide Column takes no affiliate commission from any source. Afamelanotide (Scenesse) is a prescription-only, clinician-administered implant approved for erythropoietic protoporphyria; it is not a cosmetic tanning product, and grey-market 'melanotan' for tanning is a separate, unapproved practice. We link only to clinician-directed care, never to sellers.
Part 07 · Your appointment

Questions to bring.

01
Is afamelanotide appropriate for my specific type of photosensitivity?
02
What monitoring is needed during treatment with Scenesse?
03
How long does a single implant provide photoprotection?
04
Are there dermatological exams needed before and during treatment?
References

Every citation, numbered.

Citation list. For our editorial read of each study — including bias flags and quality grades — see the Research log above.

  1. 01.
    Afamelanotide for erythropoietic protoporphyria — phase 3 · New England Journal of Medicine, 2015 · PMID 26132941 ↗
  2. 02.
    Afamelanotide + narrowband UV-B for vitiligo — RCT · JAMA Dermatology, 2015 · PMID 25230094 ↗
  3. 03.
    Afamelanotide for prevention of phototoxicity in EPP (real-world review) · Expert Rev Clin Pharmacol, 2021 · PMID 33507118 ↗
  4. 04.
    FDA prescribing information. Official US label — Scenesse (afamelanotide) · Source ↗
  5. 05.
    EMA. Scenesse EU authorization (2014) · Source ↗