Library / Peptides / Skin & Hair / Afamelanotide
Strong evidence · Grade A

Afamelanotide

Melanotan 1 (Afamelanotide)
Score
82 / 100
Class
Skin & Hair
Brand
Scenesse
FDA
2019
TL;DR
Afamelanotide (formerly Melanotan 1, marketed as Scenesse) is a synthetic analogue of alpha-melanocyte-stimulating hormone (alpha-MSH) that stimulates melanin production. It was FDA-approved in October 2019 for the prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP), a rare genetic disorder causing extreme light sensitivity.
Part 01 · How it works

Mechanism.

Afamelanotide (formerly Melanotan 1, marketed as Scenesse) is a synthetic analogue of alpha-melanocyte-stimulating hormone (alpha-MSH) that stimulates melanin production. It was FDA-approved in October 2019 for the prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP), a rare genetic disorder causing extreme light sensitivity. It is the first FDA-approved melanocortin receptor agonist for photoprotection.

Afamelanotide is like turning up the dimmer switch on your skin's natural sunscreen system. Your body already makes melanin to protect against light damage -- this peptide simply tells the melanin factory to increase production, providing a stronger built-in shield.

Mechanism · technical
Afamelanotide binds to melanocortin 1 receptors (MC1R) on melanocytes, stimulating the production of eumelanin (the photoprotective brown-black pigment). This increases the skin's natural defense against UV radiation and visible light. Unlike natural alpha-MSH which is rapidly degraded, afamelanotide has a modified amino acid sequence (Nle4, D-Phe7 substitutions) that makes it resistant to enzymatic breakdown and extends its duration of action.
Part 02 · Dosing & administration

How it's taken.

Values below describe how Afamelanotide has been administered in published trials and labeling. 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.

Standard dose
16 mg subcutaneous implant
Subcutaneous implant · Every 60 days
Duration
Per FDA labeling for EPP — ongoing as needed

FDA-approved as Scenesse for EPP. Administered by healthcare provider only. Available through REMS program.

Need help with reconstitution?

Use the free peptide calculator for dilution, unit conversion, and injection volume.

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Part 03 · Safety

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

Reported side effects
Common side effects include nausea, headache, nasopharyngitis, back pain, and implant site reactions (pain, redness). Skin darkening is expected and inherent to its mechanism. There have been reports of darkening of pre-existing nevi (moles), so dermatological monitoring is recommended. Long-term melanoma risk has been studied without evidence of increased risk, but ongoing monitoring is standard.
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
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?

Scores derived from rating, indexed studies, regulatory status, and catalogued safety data for this peptide. Curated per-peptide scoring replaces this when available.

82
Grade B
Grade B. Evidence is strongest where indications match regulatory approval — pair with a clinician when applying beyond label.
Clinical efficacy
Rating reflects consistent peer-reviewed evidence in its indication.
86
Study quality
2 indexed studies in our dataset. Designs vary — see Research log for per-study grades.
71
Regulatory clarity
FDA-approved for at least one indication.
90
Safety profile
Based on 5 documented contraindications, 3 interactions, 4 lab checkpoints.
88
Long-term data
Years of post-approval surveillance available.
74
Part 05 · Research log

Every study we cite.

Each study with its published finding and a plain-language note on limitations or funding.

01
2015
0
Efficacy and Safety of Afamelanotide for EPP
Significantly increased time EPP patients could spend in sunlight without pain
Pivotal Phase III RCT; industry-sponsored
PMID 25601081 ↗
02
2015
0
Afamelanotide and NB-UVB for Vitiligo
Combination produced superior repigmentation vs NB-UVB alone
Multicenter RCT; moderate sample size
PMID 25354142 ↗
Part 06 · Cost & access

Where you can get it.

Regulatory status
FDA-approved (October 2019) as Scenesse for erythropoietic protoporphyria in adults. Also approved by the EMA in Europe (2014). Available only through a restricted program (Scenesse REMS) and administered as a subcutaneous implant by healthcare providers.
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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?