Name: Melanotan I
Brand: Amino Club
SKU: Melanotan I - 10MG
Availability: InStock
Rating: 5.0 (1 reviews)

Melanotan I | 99%+ Pure Peptide | Amino Club | Amino Club

Safety Profile

From FDA registration trials and long-term observational data

Afamelanotide has a well-characterized safety profile from three vehicle-controlled RCTs (n=125 active treatment) and long-term observational studies up to 8 years. Most adverse events are mild and self-limiting.

Common Digestive Issues

38%

Headache

mild

26%

Nausea

mild

21%

Implant site reaction

mild

18%

Nasopharyngitis

mild

10%

Back pain

mild

Fatigue

mild

Pharmacological Effect

Skin Hyperpigmentation

Darkening of skin, lips, and existing moles/freckles is the intended pharmacological effect. This is not a side effect per se but a consequence of melanin stimulation.

Diffuse skin darkening occurs in nearly all patients
Existing moles and freckles may darken
Lip pigmentation commonly reported
Pigmentation reverses weeks to months after cessation

Discontinuation Rates

Treatment Tolerability

16mg implantWell tolerated

Long-term (8 years)No new safety signals

25-year follow-upNo late effects

No immunogenic potential detected

No additional safety signals in 8-year observational study of 115 patients

Adverse events mostly mild and self-limiting

Trial Exclusions

Monitoring Recommendations

Full-body skin examination every 6 months (skin cancer screening)Monitor existing moles for changes in size, shape, or colorSun protection measures still recommended despite increased pigmentationContraindicated in patients with hypersensitivity to afamelanotide

Rare Considerations

Skin hyperpigmentation requiring no intervention (cosmetic)

New melanocytic nevi formation (monitor dermatologically)

Implant expulsion (rare, requires re-administration)

No serious adverse events attributed to study drug in Phase 3 trials

Researcher Notes

FDA-approved safety profile with extensive clinical data
No drug interactions reported to date
No adverse developmental effects in animal models at 12x human dose
Side effects generally mild compared to Melanotan II due to MC1R selectivity

Frequently Asked Questions

Common questions about Melanotan I research

Melanotan I (afamelanotide) is a linear 13-amino acid peptide that selectively targets MC1R for pigmentation with minimal effects on sexual function or appetite. Melanotan II is a cyclic 7-amino acid peptide that non-selectively activates MC1R through MC5R, producing both tanning and pro-erectile effects. Melanotan I has been developed into an FDA-approved drug (Scenesse) for erythropoietic protoporphyria, while Melanotan II remains a research compound. MT-I's selectivity results in a cleaner side effect profile focused on pigmentation.

Yes. Afamelanotide (brand name Scenesse) was approved by the FDA in October 2019 for increasing pain-free light exposure in adult patients with erythropoietic protoporphyria (EPP). It was previously approved by the European Medicines Agency in 2014 and the Australian TGA. It is the first FDA-approved melanocortin receptor therapy for a dermatological condition. The approved formulation is a 16mg controlled-release subcutaneous implant.

Melanotan I activates MC1R on melanocytes, triggering the cAMP-PKA signaling cascade that stimulates eumelanin (dark, photoprotective pigment) synthesis. Unlike UV-induced tanning, which requires DNA damage to initiate the signaling, afamelanotide directly activates the receptor. Clinical trials showed it works even in individuals with MC1R genetic variants who typically cannot tan from UV exposure. Pigmentation develops over 5-7 days and persists weeks to months after discontinuation.

Beyond its FDA-approved indication for EPP, afamelanotide is being investigated in Phase 2/3 clinical trials for vitiligo (combined with NB-UVB phototherapy to accelerate repigmentation). Published studies also demonstrate efficacy in polymorphic light eruption, solar urticaria, and Hailey-Hailey disease. Smaller studies have explored its potential in acne vulgaris. Its dual photoprotective and anti-inflammatory mechanisms make it a versatile candidate for multiple photosensitive conditions.

Based on FDA registration trials (n=125 active treatment), the most common side effects were headache (38%), nausea (26%), implant site reactions (21%), and nasopharyngitis (18%). Skin darkening occurs in nearly all patients but is the intended pharmacological effect. No serious adverse events were attributed to afamelanotide in Phase 3 trials, and an 8-year observational study showed no additional safety signals. Compared to Melanotan II, MT-I causes minimal sexual side effects or appetite suppression due to its MC1R selectivity.

Melanotan I

Frequently Researched Together

GHK-Cu

Targeted Melanin Production

Melanocortin-1 Receptor

Why MC1R Selectivity Matters

Triple Photoprotection

Pain-Free Sun Exposure (Hours, 6 Months)

Key Findings from Registration Trials

Phototoxic Reactions: Afamelanotide vs Placebo (EU Study)

UV Defense Enhancement

Repigmentation Potential

Broader Research Uses

Headache

Nausea

Implant site reaction

Nasopharyngitis

Back pain

Fatigue

Skin Hyperpigmentation

Treatment Tolerability

Monitoring Recommendations

💡Researcher Notes

What Is Melanotan I?

Stability Information

Where It Stands

What is the difference between Melanotan I and Melanotan II?

Is Melanotan I FDA approved?

How does Melanotan I produce tanning?

What conditions is it being researched for beyond EPP?

What are the main side effects?

Afamelanotide for Erythropoietic Protoporphyria

Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Dermatology

Afamelanotide: An Orphan Drug with Potential for Broad Dermatologic Applications

Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo

Afamelanotide | C78H111N21O19 | CID 16197727

⚠️Important Research Notice

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Frequently Researched Together

GHK-Cu

Researcher Notes