Which is better, Melanotan I (afamelanotide) or Melanotan II?
Afamelanotide is FDA approved and graded human RCT from two multicenter phase 3 trials in 168 patients with erythropoietic protoporphyria (for example, 6.0 versus 0.8 hours of pain-free sunlight exposure in the EU trial). It is selective for MC1R, so it lacks the sexual, appetite, and nausea effects of Melanotan II. Melanotan II is nonselective, has only two 10 man trials, has no lawful compounding basis, and has case reports of priapism, eruptive moles, renal infarction, and FDA cited melanoma reports. The win applies to the approved implant for its approved use, not to tanning. [1] [2] [3] [4] [5]
How do Melanotan I (afamelanotide) and Melanotan II compare?
| Dimension | Melanotan I (afamelanotide)Favored | Melanotan II |
|---|---|---|
| What it is [2] [3] | Linear 13 amino acid alpha-MSH analog, selective MC1R agonist, delivered as a 16 mg controlled release implant. | Cyclic 7 amino acid alpha-MSH analog, nonselective agonist at MC1R, MC3R, MC4R, and MC5R. |
| Effects beyond pigmentation [3] [4] [6] | Little MC3R or MC4R activity, so no meaningful effect on sexual function or appetite. | Erections, increased sexual desire, reduced appetite, stretching and yawning, and nausea from MC3R and MC4R activation. |
| Human evidence [1] [3] [4] | Two randomized, double-blind phase 3 trials in erythropoietic protoporphyria (94 and 74 patients): more pain-free sun exposure and fewer phototoxic reactions. | Two double-blind crossover trials of 10 men each with erectile dysfunction; no trial for tanning. |
| FDA status [2] [5] | FDA approved as Scenesse (October 2019) for adults with phototoxicity from erythropoietic protoporphyria; approved in the EU in 2014. | Not approved in any country; its Category 2 nomination was withdrawn but it is not on the bulks list or an approved drug component, so it cannot be compounded. |
| Safety profile [2] [4] [5] [7] [8] [9] | Implant site reactions, nausea, headache, darkening of moles and new freckles; the label requires full body skin exams twice yearly. | Severe nausea in trials; case reports of eruptive moles within 24 hours, priapism, and renal infarction; FDA cites reports of melanoma and encephalopathy. |
| Route and dosing [2] [3] | One 16 mg implant inserted under the skin every 2 months by a trained provider at a certified center. | Single 0.025 mg/kg subcutaneous injections in trials; tanning schedules sold online have no literature basis. |
| WADA status [10] [11] | Not on the WADA Prohibited List. | Prohibited at all times under S0 (non-approved substances). |
| Cost and access [2] [12] | Specialty orphan drug priced in the tens of thousands of USD per implant before insurance, dispensed only through certified centers for the approved indication. | No lawful channel; gray market vials have been found unsterile or mislabeled. |
Evidence grade and regulatory status
Pulled from each peptide’s own record, so it stays in step with the peptide pages.
| Attribute | Melanotan I (afamelanotide) | Melanotan II |
|---|---|---|
| Class | Synthetic linear 13 amino acid analog of alpha-melanocyte stimulating hormone, selective MC1R agonist, delivered as a subcutaneous implant | Synthetic cyclic heptapeptide analog of alpha-melanocyte stimulating hormone; nonselective melanocortin receptor agonist (MC1R, MC3R, MC4R, MC5R) |
| What it is | FDA approved implant (Scenesse, 2019) that lets people with erythropoietic protoporphyria tolerate sunlight; not approved or sold for tanning. | Unapproved tanning and libido injection with two tiny 1990s erection trials, case reports of melanoma and prolonged erections, and no lawful source. |
| Evidence | Evidence: Human RCT evidence | Evidence: Human RCT evidence |
| FDA status | Regulatory: FDA approved | Regulatory: Removed from Category 2 (Apr 2026) |
| Compounding | FDA approved as Scenesse (afamelanotide) implant on October 8, 2019, for adults with a history of phototoxic reactions from erythropoietic protoporphyria; the European Medicines Agency approved it in 2014. It is dispensed only through certified specialist centers because insertion requires training. Afamelanotide is not on any 503A or 503B bulks list; as the active ingredient of an approved drug it could in principle be compounded in another dosage form, but injectable Melanotan I sold online for tanning is not a compounded prescription product and is marketed unlawfully. | Melanotan II was placed on the FDA 503A Category 2 list (substances that may present significant safety risks) with FDA citing immunogenicity risk, peptide impurities, and published case reports of melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome, and priapism. As of the FDA page current to April 22, 2026, its nomination has been withdrawn, so it no longer sits in Category 2, but it is not on the 503A bulks list, was not among the peptides the Pharmacy Compounding Advisory Committee took up in July 2026, and is not a component of any approved drug. A 503A pharmacy therefore has no basis to compound it. It is not approved as a drug in any country. |
| WADA | WADA: Not WADA prohibited | WADA: WADA prohibited |
| Routes | Subcutaneous controlled release implant inserted by a trained provider (Scenesse), Injectable Melanotan I vials sold online are unapproved products and not the approved dosage form | Subcutaneous injection (trials and as sold), Nasal spray (as sold; no studies), Products labeled research use only are not lawful for human use |
| Typical cost | Specialty orphan drug priced in the tens of thousands of USD per implant before insurance, with several implants per year; insurance and manufacturer support programs determine out of pocket cost for approved patients. It is not sold for cosmetic use. Gray market Melanotan I vials are not lawful for human use and are not verified for purity. | Not available through licensed channels. Gray market vials are sold online for tanning, but those products are not lawful for human use and have been found unsterile or mislabeled. |
| Last verified |
Has Melanotan I (afamelanotide) been tested directly against Melanotan II?
No published trial has compared Melanotan I (afamelanotide) and Melanotan II directly. The dimensions above come from separate studies and labels, and cross-trial comparisons are less reliable than a direct trial.
What do Melanotan I (afamelanotide) and Melanotan II cost?
| Dimension | Melanotan I (afamelanotide) | Melanotan II |
|---|---|---|
| Typical cost | Specialty orphan drug priced in the tens of thousands of USD per implant before insurance, with several implants per year; insurance and manufacturer support programs determine out of pocket cost for approved patients. It is not sold for cosmetic use. Gray market Melanotan I vials are not lawful for human use and are not verified for purity. | Not available through licensed channels. Gray market vials are sold online for tanning, but those products are not lawful for human use and have been found unsterile or mislabeled. |
| Price detail | Price index in progress | Price index in progress |
Where a price index exists, the range is the cash price per month across branded, compounded, and telehealth channels, without insurance. The cost pages give each channel separately with its sources. Otherwise the typical cost from the peptide record is shown. Legal access depends on your state: see peptide legality by state.
Frequently asked questions
Can I use Melanotan I for tanning?
Not lawfully. The approved product, Scenesse, is an implant for adults with erythropoietic protoporphyria dispensed through certified centers, and it is not approved for cosmetic tanning. Injectable Melanotan I sold online is not a compounded prescription product and is marketed unlawfully. [2] [12]
Why is Melanotan II riskier than Melanotan I?
Melanotan II activates several melanocortin receptors, which causes nausea, spontaneous erections, and appetite changes, and it has case reports of priapism, eruptive moles, and renal infarction. It was never taken through safety trials. Afamelanotide is MC1R selective and has phase 3 safety data under a label that requires skin surveillance. [1] [4] [7] [8] [9]
Do either cause skin cancer?
Causation has not been shown for either, but both darken existing moles and can cause new ones. The Scenesse label requires full body skin exams twice yearly, and FDA has cited published case reports of melanoma associated with Melanotan II. [2] [5] [7]
Are they allowed in sport?
Afamelanotide is not on the WADA Prohibited List. Melanotan II is prohibited at all times under S0 as a non-approved substance. [10] [11]
Conditions studied
From the blog
- Melanotan 1 before and after: what the afamelanotide trials measured
Melanotan 1 is afamelanotide, approved only as an implant for a rare light sensitivity disease. What the tanning and approval trials measured, what happens to moles, and why tanning use is unapproved.
- Melanotan 2 before and after: what trials and case reports show
Melanotan 2 before and after photos show a tan. Early trials measured it in a few men; case reports since document new moles, melanoma, priapism and FDA safety concerns.
Sources
Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.
- [1]Langendonk JG et al. Afamelanotide for erythropoietic protoporphyria. N Engl J Med 2015PubMed 26132941, 2015
- [2]FDA prescribing information for Scenesse (afamelanotide) implant, via DailyMedFDA, 2025
- [3]Wessells H et al. Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study. J Urol 1998PubMed 9679884, 1998
- [4]Wessells H et al. Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction. Urology 2000PubMed 11018622, 2000
- [5]FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (Category 2 list and withdrawn nominations, current as of April 22, 2026)FDA, 2026
- [6]Wu J et al. Afamelanotide: an orphan drug with potential for broad dermatologic applications. J Drugs Dermatol 2021PubMed 33683075, 2021
- [7]Schulze F et al. Eruptive naevi and darkening of pre-existing naevi 24 h after a single mono-dose injection of melanotan II. Eur J Dermatol 2014PubMed 24334249, 2014
- [8]Dreyer BA et al. Melanotan-induced priapism: a hard-earned tan. BMJ Case Rep 2019PubMed 30796078, 2019
- [9]Peters B et al. Melanotan II: a possible cause of renal infarction: review of the literature and case report. CEN Case Rep 2020PubMed 31953620, 2020
- [10]WADA Prohibited ListWADA, 2026
- [11]WADA Prohibited List, section S0 non-approved substancesWADA, 2026
- [12]FDA: Compounding and the FDA, questions and answersFDA, 2026
Cite this page
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PeptideAgent. (2026, September 22). Melanotan I (afamelanotide) vs Melanotan II: evidence, cost, and legality. https://peptideagent.ai/compare/melanotan-i-vs-melanotan-ii- HTML link
<a href="https://peptideagent.ai/compare/melanotan-i-vs-melanotan-ii">Melanotan I (afamelanotide) vs Melanotan II: evidence, cost, and legality</a>, PeptideAgent, updated September 22, 2026.