Is afamelanotide the same as Melanotan 1?

Afamelanotide is the α-MSH analog first synthesized in 1980 and given to volunteers, and PubChem lists 'Melanotan' among its synonyms. Products sold online as 'melanotan I' are unregulated and untested; a 2017 review contrasts them with the approved, tested afamelanotide.

How is afamelanotide given?

As a biodegradable controlled-release implant containing 16 mg, placed under the skin; the trials used one implant every 60 days.

What is the difference between Melanotan 1 and Melanotan 2?

Afamelanotide (Melanotan I) is approved and has randomized trials behind it. Melanotan II is a shorter cyclic analog that was never approved; its controlled human data are three small studies.

Afamelanotide (Melanotan I): Trials & FDA Approval

Q: Is afamelanotide FDA-approved?

Yes, as Scenesse, a subcutaneous implant with an original approval date of October 8, 2019. Its approved use is preventing phototoxicity in erythropoietic protoporphyria, not cosmetic tanning.

Afamelanotide (Melanotan I)

The first α-MSH analog given to people, and the one that became a medicine: a 16 mg implant approved for a rare light-sensitivity disorder.

Also called Melanotan I · MT-I · Melanotan 1 · Scenesse · CUV1647

Best evidence: Approved / regulatory-grade

FDA-approved (Scenesse, NDA 210797) for erythropoietic protoporphyria on the basis of randomized, placebo-controlled trials. Other uses are graded separately.

FDA-approved (Scenesse implant) · Prescription

**Identifiers** retrieved from PubChem.
PubChem CID	16197727 “Afamelanotide”
Formula	C78H111N21O19
Molecular weight	1,646.8 g/mol
CAS (as listed)	75921-69-6
InChIKey	UAHFGYDRQSXQEB-LEBBXHLNSA-N
Length	13 residues
Route in trials	Subcutaneous controlled-release implant, 16 mg
Originator	Clinuvel
Mechanism	Melanocortin-1 receptor agonist; raises eumelanin without UV exposure

What is afamelanotide?

Afamelanotide is a synthetic analog of α-melanocyte-stimulating hormone. It was synthesized in 1980 and was the first α-MSH analog given to human volunteers, chosen because it is more active and stable than the natural hormone2. PubChem lists the formula C78H111N21O1977PubChemPubChem compound record: Afamelanotide. C78H111N21O19 · MW 1646.8 g/mol.. It is marketed as Scenesse, a 16 mg biodegradable implant1.

How does afamelanotide work?

It binds the melanocortin-1 receptor. MC1R signaling increases melanin synthesis, induces antioxidant activity, enhances DNA repair and modulates inflammation2. It can activate eumelanin production without UV exposure6. In volunteers, neither MC1R variants nor fair skin reduced the pigmentation response2.

What have studies found?

Erythropoietic protoporphyria. EPP is an inherited disorder of heme synthesis in which light causes severe burning pain6. Two multicenter, randomized, double-blind, placebo-controlled trials tested the 16 mg implant every 60 days. In the US trial, median pain-free time in direct sunlight over six months was 69.4 hours versus 40.8 hours on placebo; in the EU trial it was 6.0 versus 0.8 hours over nine months, with fewer phototoxic reactions. Quality of life improved in both3.

Real-world use. At the Massachusetts General Hospital porphyria center, 29 adults received afamelanotide in 2021–2022. Among the 26 with at least two implants, median time to symptoms in sunlight rose from 12.5 to 120 minutes. Protoporphyrin levels and liver tests did not improve5.

Registered trials. ClinicalTrials.gov lists studies in EPP, vitiligo, polymorphic light eruption, acne and other conditions88TrialClinicalTrials.gov registry search: afamelanotide OR CUV1647. 23 registered studies at fetch..

What is its safety record?

In the phase III trial CUV039, no drug-related serious adverse events were reported; headache and implant-site reactions were common1. A 2017 review reported no late effects in volunteers 25 years after first exposure or in EPP patients treated for up to 8 years, and that an immunogenic potential had been excluded2.

Is Afamelanotide FDA-approved?

**Table 1. Regulatory status of Afamelanotide in the United States** — from Drugs@FDA (openFDA) and FDA’s bulk-substance compounding categories, as fetched.
Record	Status	Source
SCENESSE NDA210797 · CLIVUNEL INC	FDA-approved original approval 2019-10-08 IMPLANT SUBCUTANEOUS	4

Drugs@FDA lists Scenesse (afamelanotide) subcutaneous implant with an original approval on October 8, 2019 and prescription marketing status4. Approval covers its labeled use in EPP. Afamelanotide is not on FDA's compounding-risk lists99FDACertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. FDA, content current as of 04/22/2026..

What is still unknown?

Dosing interval. The 60-day interval was not based on effectiveness studies, and one review suggests four implants a year may be insufficient for some patients6.
Other indications such as vitiligo rely on smaller studies2.
Unregulated 'melanotan' products are a separate problem: case reports link them to changing moles, new dysplastic naevi and four melanomas, without conclusive evidence of cause1010PubMedRisks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review. Habbema L et al. Int J Dermatol. 2017..

What effects has Afamelanotide shown, by body system?

Each row is graded separately using the Residue evidence scale: a compound can carry an A for one use and a D for another.

**Table 2.** Research-observed effects of Afamelanotide by body system, with the strongest evidence available for each.
System	What was observed	Grade
Erythropoietic protoporphyria (light tolerance)	Longer pain-free sunlight exposure and fewer phototoxic reactions versus placebo in two RCTs3.	A
Quality of life (EPP)	Improved on validated questionnaires in both trials and in a US clinic cohort3,5.	A
Skin pigmentation (volunteers)	Ten daily SC doses produced long-lasting pigmentation, including in fair skin and MC1R variants2.	C
Other skin disorders	Reported results in polymorphic light eruption, solar urticaria, Hailey-Hailey disease and vitiligo2.	C

How much research is there on Afamelanotide?

Figure 2. PubMed records per publication year matching (afamelanotide[tiab] OR "melanotan I"[tiab] OR "melanotan-I"[tiab]) — 121 in total; peak 17 in 2023. The 2026 bar is year-to-date (hatched). Volume of literature is not evidence of efficacy. Run this query on PubMed.

Registered studies of Afamelanotide by phase and status
Phase	Studies	Breakdown
Phase 1	3	3 completed, 0 active or recruiting, 0 stopped, 0 other
Phase 2	13	9 completed, 0 active or recruiting, 0 stopped, 4 other
Phase 3	6	5 completed, 1 active or recruiting, 0 stopped, 0 other
Observational	1	1 completed, 0 active or recruiting, 0 stopped, 0 other

Figure 3. 23 studies on ClinicalTrials.gov match the registry search afamelanotide OR CUV1647. Multi-phase studies are counted at their highest phase. Open the full trial feed

Afamelanotide (Melanotan I)

What is Afamelanotide?

Key findings

What is Afamelanotide, chemically?