Evidence grade A
Research stage: Approved as the Scenesse 16 mg implant for erythropoietic protoporphyria in adults (EU 2014, FDA 2019); approval does not extend to this research vial.
Product description
MT-1 is afamelanotide, also called Melanotan I, a 13-amino-acid analog of alpha-melanocyte-stimulating hormone. This PEPTYVA 10 mg vial is for laboratory research only; afamelanotide approvals cover the branded Scenesse implant, not this vial.
MT-1 (Afamelanotide) 10 mg Research Vial
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Alternate name |
Afamelanotide; Melanotan I; [Nle4, D-Phe7]-alpha-MSH |
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Compound class |
Synthetic 13-amino-acid alpha-MSH analog; melanocortin receptor agonist |
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Format |
Vial |
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Strength(s) |
10 mg per vial |
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Sequence |
Ac-Ser-Tyr-Ser-Nle-Glu-His-D-Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2 |
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Molecular formula |
C78H111N21O19 |
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Molecular weight |
1646.8 g/mol |
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CAS number |
75921-69-6 |
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Purity |
Stated per lot on the Certificate of Analysis |
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Manufacturer |
PEPTYVA, Mexico |
What is MT-1?
MT-1 afamelanotide is offered here as a 10 mg research vial. MT-1 is the research name for afamelanotide, also known as Melanotan I: a synthetic 13-amino-acid analog of alpha-melanocyte-stimulating hormone (alpha-MSH). PEPTYVA manufactures this vial in Mexico, and Peptides Vallarta sells it for laboratory research use only. It is not Scenesse and it is not a medicine.
Afamelanotide differs from native alpha-MSH at two positions: norleucine replaces methionine at position 4, and D-phenylalanine replaces L-phenylalanine at position 7. These changes were designed to give a stronger receptor affinity and a longer biological half-life than the natural hormone.
How does MT-1 act at melanocortin receptors?
Afamelanotide is a melanocortin receptor agonist that binds predominantly to the melanocortin 1 receptor (MC1R), according to the FDA label for Scenesse. MC1R is expressed on melanocytes, the pigment-producing cells of the skin.
Because of that receptor profile, afamelanotide is studied in photobiology and pigment-cell research, where MC1R signaling in melanocytes is the main read-out.
What is the approved afamelanotide product?
Afamelanotide is approved as Scenesse, a 16 mg bioresorbable implant. The European Commission authorized it on 22 December 2014, under exceptional circumstances, for "prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP)".
FDA approved Scenesse on 8 October 2019 "to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)". The current US label, revised in August 2024, keeps the indication limited to adults and lists warnings for hypersensitivity and for skin monitoring.
What did the main clinical trials study?
Two randomized, double-blind, placebo-controlled clinical trials published in 2015 tested the 16 mg implant in people with EPP: 74 participants in the European Union and 94 in the United States. The primary end point was the number of hours of direct sunlight exposure without pain.
The authors reported longer pain-free exposure in the afamelanotide groups than with placebo and described adverse events as mostly mild. These data describe the Scenesse implant in a rare light-sensitivity disorder only.
Why does the implant evidence not apply to this vial?
The trial data and both approvals belong to one specific product: the Scenesse 16 mg implant, with its own formulation, release characteristics, manufacturing dossier and labeling. This PEPTYVA vial differs in format and strength and is not covered by the FDA or EMA approvals.
For that reason, evidence for Scenesse cannot be transferred to this vial, and the regulatory approval does not extend to this research material. The A grade on this page refers to the approved active ingredient, not to the vial.
How does MT-1 differ from MT-2?
MT-1 and MT-2 are both alpha-MSH analogs, but they differ in structure, receptor profile and regulatory history. MT-1 is a linear 13-residue peptide that binds mainly MC1R and is approved as Scenesse. MT-2, our melanotan II 10 mg research peptide, is a shorter cyclic compound that acts on several melanocortin receptor subtypes and has no approved product. Data for one cannot be applied to the other.
Documentation
Each PEPTYVA lot is traceable by its lot number. The Certificate of Analysis for your lot can be requested before or after purchase; see Quality & Documentation for what a COA typically lists.
Storage and handling
Keep the unopened vial in its original packaging, protected from light and heat, at the temperature printed on the PEPTYVA label. Check the label and lot documentation for the storage conditions and expiry date of your lot.
Supplier statement (PEPTYVA). Supplier positioning, not verified by Peptides Vallarta.
Melanocortin of interest in pigmentation and photobiology.
Regulatory status
- United States
- FDA approved Scenesse (afamelanotide) implant, 16 mg, on 8 October 2019 (NDA 210797) "to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)". The approval belongs to Scenesse and does not extend to this research vial.
- Mexico (COFEPRIS)
- Under Article 376 of the Ley General de Salud, medicines in Mexico require a registro sanitario. This PEPTYVA MT-1 vial is sold for laboratory research use only and is not offered as a registered medicine.
References
References pending.
Research use disclaimer
Research use only. This product is sold exclusively for laboratory research and in vitro analysis. It is not for human or veterinary use. It is not a medication, drug or medical device, and it is not intended to diagnose, cure or prevent any condition.
The buyer is responsible for safe handling, storage and disposal in line with applicable regulations.
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