FDA-Approved — Specific Indication Only Authoritative Evidence Reference Approved clinical use (SCENESSE implant)

Afamelanotide

Synthetic alpha-MSH analogue ([Nle4, D-Phe7]-alpha-MSH), MC1R agonist; SCENESSE 16 mg implant, FDA-approved October 2019 for adults with phototoxic reactions from erythropoietic protoporphyria.

Language: English العربية (Arabic) →
Drug Class Melanocortin 1 receptor (MC1R) agonist.
FDA Regulatory Status FDA-Approved — Specific Indication Only
Clinical Stage Approved clinical use (SCENESSE implant)
Evidence Verification Active Reference Standards
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60-Second Scientific Briefing

Afamelanotide (SCENESSE, also known as MT-1 or Melanotan I) is a synthetic analogue of alpha-melanocyte-stimulating hormone that activates the MC1 receptor and increases eumelanin in the skin. The US FDA approved it in October 2019 as a 16 mg implant placed under the skin every 2 months to increase pain-free light exposure in adults with erythropoietic protoporphyria (EPP), a rare light-sensitivity disorder. It is not approved for cosmetic tanning.

What is Afamelanotide?

Pharmacological Classification & Molecular Identity

Afamelanotide is a synthetic peptide analogue of alpha-melanocyte-stimulating hormone (alpha-MSH), supplied as a 16 mg bioresorbable implant (SCENESSE). It is also known as MT-1 or Melanotan I. [1] U.S. Food and Drug Administration (Drugs@FDA), 2019 ↗

Verified Chemical & Regulatory Registry Identifiers

Documented Aliases & Research Codes:
SCENESSE MT-1 Melanotan I [Nle4, D-Phe7]-alpha-MSH

Mechanism of Action & Receptor Targets

Biological Pathway and Target Binding

Receptor Selectivity: Binds predominantly to the melanocortin 1 receptor (MC1R) and increases the production of eumelanin in the skin independently of exposure to sunlight or artificial UV light (prescribing information). [1] U.S. Food and Drug Administration (Drugs@FDA), 2019 ↗

Regulatory & FDA Approval Status

Legal and Regulatory Classifications
⚠️ FDA APPROVED MEDICATION STATUS (SPECIFIC INDICATION ONLY)

Approved by the US FDA in October 2019 (SCENESSE implant) to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). Cosmetic tanning and other uses are not approved. [1] U.S. Food and Drug Administration (Drugs@FDA), 2019 ↗

Approved by the US FDA in October 2019 (SCENESSE implant) to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). Cosmetic tanning and other uses are not approved.

Human Evidence & Clinical Trials

Clinical Study Readouts and Evidence Syntheses

Two multicentre, randomised, double-blind, placebo-controlled trials of 16 mg implants every 60 days (NEJM 2015): in the US trial (94 patients, 6 months) median pain-free time in direct sunlight was 69.4 vs 40.8 hours with placebo; in the EU trial (74 patients, 9 months) it was 6.0 vs 0.8 hours, and phototoxic reactions were fewer (77 vs 146). Quality of life improved in both trials. The prescribing information reports the US study CUV039 (93 subjects): median 64.1 vs 40.5 hours over 180 days. [1] U.S. Food and Drug Administration (Drugs@FDA), 2019 ↗ [2] N Engl J Med, 2015 ↗

Clinical Evidence

Two multicentre, randomised, double-blind, placebo-controlled trials of 16 mg implants every 60 days (NEJM 2015): in the US trial (94 patients, 6 months) median pain-free time in direct sunlight was 69.4 vs 40.8 hours with placebo; in the EU trial (74 patients, 9 months) it was 6.0 vs 0.8 hours, and phototoxic reactions were fewer (77 vs 146). Quality of life improved in both trials. The prescribing information reports the US study CUV039 (93 subjects): median 64.1 vs 40.5 hours over 180 days.

Safety Profile & Clinical Limitations

Documented Adverse Events and Known Uncertainties

In the trials (125 on SCENESSE, 119 on vehicle) the most common adverse reactions were implant-site reactions (21% vs 10%), nausea (19% vs 14%), oropharyngeal pain (7% vs 5%), cough (6% vs 3%), fatigue (6% vs 3%), skin hyperpigmentation (4% vs 0%), dizziness, melanocytic naevus and respiratory tract infection (4% each). The label warns that it may darken the skin and existing moles and freckles, and recommends a full-body skin examination twice a year. There are no contraindications in the label. [1] U.S. Food and Drug Administration (Drugs@FDA), 2019 ↗ [2] N Engl J Med, 2015 ↗

ℹ️ Active Research Safety Surveillance

The pivotal trials lasted 6 to 9 months and enrolled mainly white adults (98%). Long-term effects on moles and pigmented lesions require skin monitoring, and use outside EPP has not been established. [1] N Engl J Med, 2015 ↗

Dose Approval Status

Commercial Dosing Status and Policy Directives
🛑 PRESCRIPTION DOSING INFORMATION (APPROVED PRODUCT ONLY)

Approved US labelling: a single 16 mg implant inserted subcutaneously above the anterior supra-iliac crest every 2 months, by a healthcare professional trained in the implantation procedure; sun and light protection continues during treatment. Dosing is set by the prescriber. [1] U.S. Food and Drug Administration (Drugs@FDA), 2019 ↗

Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.

Storage & Handling Status: Per the US prescribing information: store in a refrigerator at 2–8 °C and protect from light. [1] U.S. Food and Drug Administration (Drugs@FDA), 2019 ↗

What is Known vs. What is Unknown

Evidence Comparison and Clinical Evidence Boundaries

✓ Confirmed Scientific Evidence

  • Afamelanotide is a synthetic peptide analogue of alpha-melanocyte-stimulating hormone (alpha-MSH), supplied as a 16 mg bioresorbable implant (SCENESSE). It is also known as MT-1 or Melanotan I.
  • Targets & Selectivity: Binds predominantly to the melanocortin 1 receptor (MC1R) and increases the production of eumelanin in the skin independently of exposure to sunlight or artificial UV light (prescribing information).
  • Two multicentre, randomised, double-blind, placebo-controlled trials of 16 mg implants every 60 days (NEJM 2015): in the US trial (94 patients, 6 months) median pain-free time in direct sunlight was 69.4 vs 40.8 hours with placebo; in the EU trial (74 patients, 9 months) it was 6.0 vs 0.8 hours, and phototoxic reactions were fewer (77 vs 146). Quality of life improved in both trials. The prescribing information reports the US study CUV039 (93 subjects): median 64.1 vs 40.5 hours over 180 days.
  • Safety considerations: In the trials (125 on SCENESSE, 119 on vehicle) the most common adverse reactions were implant-site reactions (21% vs 10%), nausea (19% vs 14%), oropharyngeal pain (7% vs 5%), cough (6% vs 3%), fatigue (6% vs 3%), skin hyperpigmentation (4% vs 0%), dizziness, melanocytic naevus and respiratory tract infection (4% each). The label warns that it may darken the skin and existing moles and freckles, and recommends a full-body skin examination twice a year. There are no contraindications in the label.

? Unknown / Under Ongoing Investigation

  • The pivotal trials lasted 6 to 9 months and enrolled mainly white adults (98%). Long-term effects on moles and pigmented lesions require skin monitoring, and use outside EPP has not been established.

Verified Questions & Answers

10 Verified scientific answers with permanent anchor keys
#1

What is Afamelanotide and how is it classified?

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Direct Answer

Afamelanotide (SCENESSE, also called MT-1 or Melanotan I) is a synthetic analogue of alpha-MSH that activates the MC1 receptor. It is an FDA-approved implant for adults with erythropoietic protoporphyria (EPP).

Authoritative Citations:
#2

What is the mechanism of action and receptor profile of Afamelanotide?

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Direct Answer

It binds mainly to the melanocortin 1 receptor (MC1R) and increases eumelanin production in the skin without needing sun or UV exposure.

Authoritative Citations:
#3

Is Afamelanotide approved by the US FDA or health authorities?

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Direct Answer

Yes, for one indication. The US FDA approved SCENESSE in October 2019 to increase pain-free light exposure in adults with phototoxic reactions from EPP. It is not approved for cosmetic tanning.

Authoritative Citations:
#4

What human clinical evidence and trials exist for Afamelanotide?

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Direct Answer

Two randomised trials (NEJM 2015, 168 patients with EPP): pain-free time in direct sunlight was longer with afamelanotide (US trial median 69.4 vs 40.8 hours; EU trial 6.0 vs 0.8 hours), and quality of life improved.

NEJM 2015: two multicentre, randomised, double-blind, placebo-controlled trials gave a 16 mg implant or placebo every 60 days. In the US trial (94 patients, three implants, 180 days) median pain-free time in direct sunlight at 6 months was 69.4 vs 40.8 hours (P=0.04). In the EU trial (74 patients, five implants, 270 days) it was 6.0 vs 0.8 hours (P=0.005), with fewer phototoxic reactions (77 vs 146). Quality of life improved in both; adverse events were mostly mild, and serious adverse events were not considered drug-related.

Authoritative Citations:
#5

What adverse effects and safety risks are documented for Afamelanotide?

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Direct Answer

Most common: implant-site reactions (21% vs 10%), nausea (19% vs 14%), oropharyngeal pain, cough and fatigue. It can darken the skin and existing moles and freckles, so the label recommends a full-body skin examination twice a year.

Authoritative Citations:
#6

What are the critical unknown safety aspects and clinical limitations of Afamelanotide?

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Direct Answer

The pivotal trials lasted 6 to 9 months and enrolled mainly white adults. Long-term effects on moles and pigmented lesions require monitoring, and use outside EPP has not been established.

Authoritative Citations:
#7

What is the approved dosing status for Afamelanotide?

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Direct Answer

Approved US labelling: one 16 mg implant under the skin above the hip bone every 2 months, inserted by a trained healthcare professional, with continued sun protection. Dosing is set by the prescriber.

Authoritative Citations:
#8

What are the storage and handling requirements for Afamelanotide?

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Direct Answer

Per the US prescribing information: refrigerate at 2–8 °C and protect from light.

Authoritative Citations:
#9

Is Afamelanotide prohibited in competitive sports by WADA?

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Direct Answer

Afamelanotide is not named on the 2026 WADA Prohibited List, and as an approved medicine it does not fall under section S0 (non-approved substances). Athletes should confirm with their national anti-doping organisation.

Authoritative Citations:
#10

What is Egypt Peptides' official medical policy regarding Afamelanotide?

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Direct Answer

Egypt Peptides publishes reviewed scientific reference monographs for documentation and research. The site does not give individual medical advice, preparation or injection instructions, combination protocols or off-label use instructions. Decisions about any medicine belong to the treating physician.

Authoritative Citations:

Authoritative Sources & Literature Registry

Regulatory dossiers, clinical trial registries, and published studies
Source [1] Tier 1 Regulatory / Academic

SCENESSE (afamelanotide) implant: prescribing information ↗

Publisher / Registry: U.S. Food and Drug Administration (Drugs@FDA) Publication Date: 2019-10-08
Verified Locator: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210797s000lbl.pdf
Source [2] Tier 1 Regulatory / Academic

Afamelanotide for Erythropoietic Protoporphyria ↗

Publisher / Registry: N Engl J Med Publication Date: 2015-07-02 Trial ID: NCT01605136 PubMed PMID: 26132941
Verified Locator: https://pubmed.ncbi.nlm.nih.gov/26132941/

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