Peptide Profile
Melanotan II
Unapproved Melanocortin Receptor Agonist
01
Overview
Composition
Synthetic cyclic heptapeptide analog of alpha-melanocyte-stimulating hormone with non-selective melanocortin receptor activity
Mechanism of Action
Activates melanocortin receptors, especially MC1R for melanogenesis and MC3R/MC4R pathways involved in central arousal and appetite signaling
Primary Effects
Associated in early research with pigmentation and sexual-arousal effects, but it is not an approved drug product and is safety-sensitive because unregulated tanning use is linked to nausea, flushing, mole changes, pigmentation changes, and product-quality risk
02
Discovery & Background
Developed from melanocortin analog research exploring alpha-MSH derivatives for pigmentation and sexual-function signaling
Small human studies in the 1990s explored erectile-function effects. Melanotan II itself did not become an approved medicine; the related derivative bremelanotide later entered approved HSDD use as Vyleesi.
Not FDA-approved for tanning, sexual function, weight loss, or any other indication; regulatory agencies warn against melanotan tanning products
03
Research Overview
Human evidence is limited to small early studies and case reports.
- 01
Non-selective melanocortin agonism can increase melanin production through MC1R activation
- 02
Early small studies evaluated erectile-function endpoints but did not establish a modern approved indication
- 03
Case reports describe systemic toxicity and changing/darkening melanocytic lesions after melanotan exposure
- 04
Regulators warn that melanotan tanning products are illegally promoted and may create serious safety risk
- 05
Pigmentation does not replace sunscreen, UV avoidance, or dermatologic screening
- 06
The related approved drug bremelanotide should not be treated as evidence that melanotan tanning products are safe
Unapproved; research-only and safety-sensitive
04
Safety Considerations
Monitoring
- New, darkening, bleeding, asymmetric, or changing moles or freckles
- Nausea, vomiting, flushing, headache, appetite changes, or dizziness
- Blood pressure, heart rate, and neurologic symptoms if systemic reactions occur
- Sterility and product-identity concerns in any research context
Side Effects
Commonly reported
- Nausea and vomiting
- Facial flushing
- Headache
- Loss of appetite
- Darkening of moles or freckles
Serious concerns
- Changing melanocytic lesions requiring dermatology evaluation
- Systemic toxicity case reports
- Unknown long-term cancer-risk profile
- Unregulated product purity and sterility risk
Contraindications
- Current or prior melanoma or suspicious skin lesions without dermatologist guidance
- Pregnancy or breastfeeding
- Uncontrolled cardiovascular disease or severe adverse reaction history
- Use as a substitute for sunscreen, UV protection, or dermatologic surveillance
05
Educational Notice
Melanotan II is unapproved and safety-sensitive. Use of melanotan products should not be promoted as safe, natural, or protective against UV exposure.
References
Research And Source List
Structured reference cards with source metadata and a direct link so users can inspect the original study/source.PubMed | 1996
Early human study of melanocortin effects in erectile-function context.PubMed | 1998
Small human clinical study; useful for history, not current approved-use framing.PubMed case report
Safety case report relevant to unregulated-product risk.PubMed case report
Case report describing darkened/changing melanocytic lesions after melanotan exposure and sun-bed use.FDA
Regulatory context for tanning risks and claims that tanning products do not protect against UV damage.FDA | 2024
Official FDA compounding safety context that includes Melanotan II.FDA technical record
Substance identity registry for Melanotan II.BMJ | 2009
Public-health warning context for unregulated melanotan use.PubMed indexed literature query
Search results for indexed publications and abstracts related to Melanotan II.ClinicalTrials.gov
Trial-registry search for study status, sponsors, and registered human-research context.Pattern Store
