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PEPTIDE ATLAS / SKIN & HAIR / AFAMELANOTIDE

FDA-approvedHigh for approved indication

Afamelanotide

Editorial visualization for skin & hair peptide research
THE SIGNAL MAP · SKIN & HAIR
ALSO KNOWN ASScenesse

An implanted melanocortin analog for erythropoietic protoporphyria—not cosmetic tanning.

01CATEGORYSkin & hair
02REGULATORY STATUSFDA-approved
03COMMON ROUTESubcutaneous implant
04DOSE BASISFDA-approved label

HOW TO USE THIS PAGE

Read the profile in the order that protects the decision.

  1. 01
    Verify what it is

    Confirm the exact molecule, route, regulatory lane and actual human evidence.

  2. 02
    Read limits before dose

    Unsupported claims, contraindications and uncertainty come before any protocol.

  3. 03
    Build the monitoring plan

    Define the target, baseline checks, reassessment point and stop rules with a qualified clinician.

RESEARCH PASSPORT

The five facts to know first.

REVIEWED
JULY 2026

HUMAN EVIDENCEHigh for approved indication

Evidence strength for the context described on this page.

REGULATORY LANEFDA-approved

Status is product-, formulation- and indication-specific.

DOSE FOUNDATIONFDA-approved label

Trial, label or reported-practice basis is always named.

SOURCE PACK2 original references

Official labels, regulators, trials and indexed literature where available.

TESTED ATHLETESVerify the exact ingredient.

Peptide hormones, growth factors and related substances may be prohibited.

Check Global DRO ↗

OVERVIEW

What Afamelanotide is.

A melanocortin-1 receptor agonist approved to increase pain-free light exposure in adults with erythropoietic protoporphyria who have a history of phototoxic reactions.

HOW IT IS THOUGHT TO WORK

Increases eumelanin production and photoprotective signaling through MC1R activation.

EFFECTS & EVIDENCE

What the evidence supports—and what it does not.

SUPPORTED IN CONTEXT
  • Increases pain-free light exposure in the labeled EPP population
NOT ESTABLISHED
  • Cosmetic tanning in the general public
  • Protection that replaces sun avoidance and photoprotection
  • Equivalence to melanotan products

Evidence grade: High for approved indication. For an approved drug, “high” refers only to its labeled indication—not every off-label or wellness claim.

DOSAGE CONTEXT

Best available dosing range.

FDA-APPROVED LABELOne 16 mg subcutaneous implant administered by a trained healthcare professional every 2 months under the label.
Route
Subcutaneous implant
Duration
Repeated at label intervals under specialist care
Men & women
No routine sex-based dose.

Clinician verification required. Always double-check the exact molecule or salt, concentration, route, volume, schedule, indication, patient-specific contraindications, interactions and applicable law with the prescribing clinician and dispensing pharmacy. A disclaimer does not make an unapproved product FDA-approved, and a reported-use range is not a prescription.

MONITORING

What should be tracked.

  • Full-body skin examination twice yearly
  • Pigmentation changes and new or changing lesions
  • EPP symptom response

SAFETY

Risks, red flags and reasons to avoid it.

KNOWN OR PLAUSIBLE RISKS
  • Implant-site reactions
  • Nausea, headache and respiratory symptoms
  • Darkening of nevi and freckles
  • Serious hypersensitivity has been reported
AVOID / ESCALATE
  • Cosmetic use
  • Untrained implantation
  • Assuming it is interchangeable with melanotan II
Stop and seek careGet urgent medical help for trouble breathing, facial or throat swelling, chest pain, fainting, severe persistent abdominal pain, neurologic changes, severe hypoglycemia, uncontrolled vomiting or a prolonged painful erection.

CLINICIAN VISIT CHECKLIST

Six questions worth bringing with you.

01What exact product is this?

Molecule or analog, salt, concentration, route, manufacturer or compounder, lot and beyond-use date.

02What outcome are we treating?

Name the diagnosis or target, how it will be measured and the realistic time to reassess.

03Why this option?

Ask how it compares with FDA-approved, lower-risk or better-studied alternatives.

04Where did the dose come from?

Label, human trial, specialty guideline or clinic convention—and whether that route and formulation match.

05What is the monitoring plan?

Baseline checks, follow-up measures, interactions, pregnancy considerations and symptoms that mean stop.

06How is quality verified?

Pharmacy license, prescription, identity/potency testing, sterility controls and who handles a product complaint.

Do not improvise reconstitution or convert “units” without the exact concentration. Mixing, storage and beyond-use instructions are product-specific; confirm them with the dispensing pharmacy.

PRIMARY SOURCES

Read the record yourself.

We prioritize official prescribing information, FDA regulatory material, registered trials and indexed biomedical literature. A source supports the specific statement beside it—not every claim made about the molecule.

PRODUCTS & TREATMENT ACCESS

Use a verified prescription pathway.

AVAILABILITY

Specialty prescription implant for EPP.

MARKET REALITY

A regulated melanocortin therapy exists, but its narrow indication and trained implantation process are the opposite of gray-market tanning injections.

VETTED CARE NETWORK

Compare qualified specialists

Coming soon: indication-matched clinicians, transparent pricing, required monitoring and verified prescription sourcing.

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