Melanotan II
Evidence: B- — Meaningful Human EvidenceDermatology / Cosmetic Research
Evidence Snapshot
What this grade covers
A for molecular identity and FDA import-alert status; C for small early human pigmentation and erectogenic studies; D/E for approved tanning, erectile-dysfunction, appetite, weight-loss, safety, or dosing claims.
Regulatory Context
Investigational and not FDA-approved as a marketed medicine. Products sold online or through gray-market channels are not established as standardized clinical-trial material.
Research Takeaway
Melanotan II is a synthetic cyclic analog of alpha-melanocyte-stimulating hormone with melanocortin-receptor agonist activity; it is distinct from afamelanotide and from bremelanotide.
Evidence boundary: Shared melanocortin pharmacology does not make these drugs interchangeable.
See all 6 evidence claims →Quick Summary
Melanotan II is an investigational cyclic melanocortin agonist with small early human studies and multiple safety case reports. It remains on publication hold.
Mechanism & Research Overview
Melanotan II is a synthetic cyclic melanocortin agonist studied in early human tanning and erectile-response experiments. It is a distinct compound from afamelanotide and bremelanotide.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
Melanotan II is a synthetic cyclic analog of alpha-melanocyte-stimulating hormone with melanocortin-receptor agonist activity; it is distinct from afamelanotide and from bremelanotide.
Does not establish
Evidence boundary: Shared melanocortin pharmacology does not make these drugs interchangeable.
Sources: Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study; MELANOTAN II substance record
Supported
Early human studies demonstrated melanotropic activity and erectile responses, confirming biological activity in people.
Does not establish
Evidence boundary: These experimental effects do not establish an approved tanning or erectile-dysfunction indication for Melanotan II.
Sources: Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study; Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study; Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction
Supported
Melanotan II is not an FDA-approved drug, and FDA identifies compounded Melanotan II as presenting potential significant safety risks.
Does not establish
Evidence boundary: An FDA substance record is not approval.
Sources: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks; Tailor Made Compounding LLC - Warning Letter; MELANOTAN II substance record
Supported
Human trials reported nausea, yawning or stretching, decreased appetite, and other systemic effects, while FDA also cites serious case-report signals including priapism, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome, and melanoma.
Does not establish
Evidence boundary: Case reports are safety signals and do not establish causality or incidence for every event.
Sources: Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study; Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction; Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
Supported
The existence of human pharmacology studies does not establish long-term safety of repeated cosmetic tanning use or equivalence of unregulated internet products to clinical-study material.
Does not establish
Evidence boundary: Short experimental studies cannot define chronic real-world risk.
Sources: Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study; Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
Supported
Only exact exposure from named historical clinical studies may appear under Study/Trial Dosing; no consumer tanning, sexual-function, reconstitution, or injection regimen may be provided.
Does not establish
Evidence boundary: Historical experimental dosing is not a recommended regimen.
Sources: Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study; Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study; Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
Systemic toxicity with rhabdomyolysis and renal dysfunction has been reported after unregulated use.Safety Consideration
Prolonged erections and priapism have been reported.Safety Consideration
Online products may have uncertain identity, purity, dose, sterility, and formulation.Safety Consideration
Case reports describe rapid darkening of pre-existing nevi, eruptive or atypical nevi, and melanoma or melanoma in situ occurring during or after Melanotan exposure, including a 2025 oral mucosal melanoma case after nasal-spray use. These reports cannot prove causation given temporal association, confounding by UV/tanning-bed exposure, uncertain product identity, and incomplete surveillance data -- but they must remain visible as safety signals and do not support a claim that melanoma risk is absent.
Research Areas Being Studied
Research areas discussed on this page reflect the Dermatology / Cosmetic Research category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
- Melanotan II Nasal Spray and Oral Mucosal Melanoma Case (2025):
- Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction (2000):
- Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study (1998):
- Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study (1996):
- Atypical Melanocytic Nevi Following Melanotan Injection ():
- Eruptive Nevi and Darkening After Melanotan II ():
- Melanoma Associated With Melanotan II Use ():
- Melanotan II and Possible Renal Infarction ():
- Melanotan Tanning Injection and Ischemic Priapism ():
- Melanotan-Induced Priapism ():
Study Tables by Evidence Type
Human Studies & Clinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Melanotan II Nasal Spray and Oral Mucosal Melanoma Case | 2025 | A 2025 case report describes oral mucosal melanoma after Melanotan II nasal-spray use. As with other melanoma case reports for this compound, this cannot establish causation but is a safety signal that must remain visible, with uncertain product identity for the nasal-spray material used. | |||
| Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction | 2000 | Melanotan II produced erectile responses in men with organic erectile dysfunction, while nausea and stretching or yawning were common and severe nausea occurred after some administrations. | |||
| Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study | 1998 | Men with psychogenic erectile dysfunction | Melanotan II initiated erections in a small trial; nausea, stretching or yawning, decreased appetite, and other transient effects occurred more often than with placebo.
| Nausea and other melanocortin effects occurred; the study does not establish routine safety. | |
| Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study | 1996 | Small group of healthy volunteers in an early phase I study | A pilot Phase 1 study evaluated Melanotan II in humans and documented melanotropic activity together with systemic adverse effects. It was not an approval trial for commercial tanning use. | Nausea, flushing, appetite effects, and spontaneous erections were reported in early development. | |
| Atypical Melanocytic Nevi Following Melanotan Injection | Case report of atypical melanocytic nevi following Melanotan injection. Case reports cannot prove causation but require the pigmentary/nevus signal to remain visible. | ||||
| Eruptive Nevi and Darkening After Melanotan II | Case report of eruptive nevi and darkening of pre-existing nevi after Melanotan II use. | ||||
| Melanoma Associated With Melanotan II Use | Case report of melanoma occurring during or after Melanotan II use. A case report cannot prove that Melanotan II caused the melanoma, given temporal association, confounding by UV/tanning-bed exposure, uncertain product identity, and incomplete surveillance data; it also does not support a claim that melanoma risk is absent. | ||||
| Melanotan II and Possible Renal Infarction | Case report and review describing possible renal infarction associated with Melanotan II use, in addition to previously reported rhabdomyolysis and systemic toxicity. Case reports do not define incidence or prove causation but are clinically serious safety signals. | ||||
| Melanotan Tanning Injection and Ischemic Priapism | Case report of ischemic priapism after a Melanotan tanning injection requiring operative management, illustrating the severity of this reported safety signal. | ||||
| Melanotan-Induced Priapism | Case report of ischemic priapism after Melanotan use. Priapism can cause tissue ischemia, permanent erectile dysfunction, and require emergency procedures. |
Animal / Cell / Preclinical Data
No Animal / Cell / Preclinical Data Listed Yet
This section will be updated as sources are added.
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | 2026 | FDA states that compounded PEG-MGF may pose significant immunogenicity and impurity/API-characterization risks and that it has not identified human exposure data for PEG-MGF drug products. FDA also lists safety concerns for compounded Melanotan II. | |||
| Meeting of the Pharmacy Compounding Advisory Committee | 2026 | FDA listed PEG-MGF and Melanotan II among bulk drug substances considered for the 503A Bulks List. Committee consideration is not approval. | |||
| MELANOTAN II substance record | 2026 | FDA GSRS provides a validated substance identity for Melanotan II. A UNII does not signify FDA approval. | FDA UNII: UPF5CJ93X7. FDA URL: https://precision.fda.gov/uniisearch/srs/unii/UPF5CJ93X7 | ||
| Tailor Made Compounding LLC - Warning Letter | 2020 | FDA identified compounded IGF1-LR3, Cerebrolysin, PEG-MGF, and Melanotan II products that did not qualify for cited section 503A exemptions and were not components of FDA-approved human drugs. |
Review Articles / Secondary Sources
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Analytical Characterization of Internet-Sold Melanotan II Products | Analytical characterization of internet-sold Melanotan II products found problems involving content, purity, identity, and undeclared or inconsistent material. Human research material used in clinical studies cannot validate the identity, purity, sterility, or potency of an online product. | ||||
| Risks of Unregulated Alpha-MSH Analogue Use | A review of unregulated alpha-MSH analogue use summarizes risks including microbial contamination, endotoxin, incorrect salt or concentration, degradation products, sterility failures, and mislabeled route or strength, in addition to the priapism, systemic toxicity, and pigmentary-lesion signals reported in individual case reports. |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Educational information only. This page summarizes published and official research and does not provide medical advice, a recommendation, or instructions for human use.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Content pending review. Last updated 2026-07-30.
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