Melanotan I and Afamelanotide: Substance Identity, Evidence, and FDA Product Boundary

Last evidence review: August 27, 2026

“Melanotan I” is an older name associated with the synthetic alpha-melanocyte-stimulating-hormone analogue now called afamelanotide. FDA’s substance registry lists Melanotan I, Melanotan-1, NDP-alpha-MSH, and CUV1647 as synonyms for afamelanotide.[1]

That synonym relationship answers a naming question. It does not show that any powder, vial, or commercial material sold under one of those names has the same sequence, salt form, quantity, formulation, impurities, stability, or quality as another product.

SCENESSE is a specific FDA-approved finished drug containing afamelanotide. Its current label describes a sterile, bioresorbable, controlled-release implant containing afamelanotide acetate with a defined polymer formulation.[2] A lyophilized research material is not SCENESSE and does not inherit its approval, indication, labeling, manufacturing controls, or clinical evidence.

This page summarizes identity, human research, and U.S. regulatory status. It does not provide medical advice or instructions for using any substance.

Identity at a glance

A UNII is a substance identifier. It is not a drug approval, a quality grade, a batch test, or evidence that a seller’s material matches the registered substance.

Is Melanotan I the same substance name as afamelanotide?

FDA’s identity record maps Melanotan I to afamelanotide. Older primary studies also used “Melanotan-I” for [Nle4,D-Phe7]-alpha-MSH.[3][4] For a carefully defined molecule, the names therefore have a historical synonym relationship.

The boundary matters at the product level. The phrase “Melanotan I” on a catalog page does not disclose:

• the complete sequence and stereochemistry;
• N- and C-terminal chemistry;
• free-base versus acetate form;
• formula and molecular mass;
• quantity in the container;
• formulation, excipients, or release profile;
• impurity, identity, and quantitative assay results for the shipped lot.

Without those records, it is not appropriate to call a catalog material afamelanotide, SCENESSE, an approved drug, a generic, or clinically equivalent.

How is SCENESSE different?

SCENESSE is the name of a finished prescription drug reviewed under NDA 210797. FDA reviewed its active ingredient, controlled-release implant formulation, manufacturing and quality information, clinical evidence, labeling, and benefit-risk record.[2][5][6]

FDA approval is attached to that finished product and its labeled use. It is not a blanket approval of every substance or product described as afamelanotide or Melanotan I.

What has been studied in laboratory and receptor research?

The current SCENESSE label describes afamelanotide as a structural analogue of alpha-MSH and reports predominant binding to MC1-R. It also describes increased eumelanin production as a pharmacodynamic effect.[2]

These statements explain the labeled product’s molecular pharmacology. Receptor activity does not establish a clinical outcome, and the label does not test or verify a separate commercial material.

Evidence tier: Official product pharmacology for the labeled active ingredient. F, unresolved for transfer to an unverified catalog material.

What did the early Melanotan-I studies examine?

Small early studies used the historical Melanotan-I name and measured pharmacokinetic or pigmentation-related endpoints. One pharmacokinetic study enrolled three men. A later study analyzed pigmentation-related measurements in seven volunteers.[3][4]

These studies help document the name’s history and early human exposure. Their small samples and narrow measurements do not support broad cosmetic, preventive, therapeutic, or long-term claims.

Evidence tier: C, Limited human evidence for the specific measurements reported.

What did the afamelanotide trials in EPP find?

A 2015 primary publication reported two multicenter, randomized, double-blind, placebo-controlled trials in adults with erythropoietic protoporphyria, a rare disorder associated with painful phototoxic reactions. The studies evaluated controlled-release afamelanotide implants and pain-free light-exposure outcomes. The report found longer pain-free exposure time on the principal measures.[7]

FDA’s review adds context that belongs beside that finding:

• FDA identified one adequate and well-controlled study plus two supporting trials.
• In the principal U.S. study, the applicant’s analysis crossed the conventional statistical boundary, while an FDA sensitivity analysis including all randomized participants did not.
• One supporting study had data-quality problems.
• Another did not reach its prespecified phototoxic-reaction endpoints; its supportive light-exposure endpoint was post hoc.

FDA considered the total record sufficient for the narrow labeled indication.[5] The result applies to the studied implant, population, protocol, and endpoints. It does not establish outcomes for a lyophilized research material or any other use.

Evidence tier: B, Human evidence for the labeled, implant-specific EPP proposition. F, Unsupported for transfer to a catalog powder.

Current U.S. FDA status

FDA approved SCENESSE in 2019. The current label indicates it to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria.[2][6]

This approval does not cover:

• a bulk substance or lyophilized research vial;
• a product marketed only under the alias Melanotan I;
• a cosmetic tanning or disease-prevention claim;
• a compounded or otherwise separately manufactured product;
• a product whose identity and formulation have not been matched to the approved record.

Status checked: August 27, 2026.

Important evidence limits

• Substance-name synonymy is not finished-product equivalence.
• SCENESSE evidence is specific to a controlled-release implant and the population and endpoints studied.
• Early Melanotan-I studies were very small and measured narrow outcomes.
• Receptor activity and pigmentation are not interchangeable with prevention, quality-of-life, or long-term clinical outcomes.
• A paper cannot establish the identity, quantity, purity, sterility, stability, or performance of a commercial lot it did not test.
• No cited source establishes that a Serum Research material is SCENESSE or equivalent to it.

Frequently asked questions

Is Melanotan I another name for afamelanotide?

FDA’s substance registry lists Melanotan I as a synonym for afamelanotide. That mapping applies at the substance-name level and does not verify a commercial material.

Is Melanotan I the same as SCENESSE?

No. SCENESSE is a specific FDA-approved controlled-release implant with reviewed composition, manufacturing controls, labeling, and clinical evidence. A material labeled Melanotan I is not SCENESSE merely because the names are related.

Is afamelanotide FDA approved?

Afamelanotide is the active ingredient in the FDA-approved finished drug SCENESSE. The approval is product- and indication-specific; it does not extend to every material bearing the ingredient name.

What is NDP-alpha-MSH?

NDP-alpha-MSH is another name used for the [Nle4,D-Phe7] alpha-MSH analogue mapped to afamelanotide in FDA’s substance record.

Do the EPP trials validate research-use Melanotan I?

No. They evaluated defined controlled-release implant products in specified clinical protocols. They did not test a Serum Research catalog material.

Does this page explain how to use Melanotan I or afamelanotide?

No. It is an identity, evidence, and regulatory-status summary and intentionally contains no personal-use instructions.

Primary and official sources

1. FDA UNII record for afamelanotide, QW68W3J66U
2. Current FDA SCENESSE prescribing information
3. Skin pigmentation and pharmacokinetics of Melanotan-I, PMID 9113347
4. Eumelanin expression study, PMID 11045725
5. FDA multidisciplinary review, NDA 210797
6. FDA approval letter, NDA 210797
7. Afamelanotide for erythropoietic protoporphyria, PMID 26132941 and NCT01605136

Suggested internal links after publication: Research Library hub; how we review evidence; approved drug versus research material; Melanotan II; quality testing. No catalog link until the gate below passes.