Human efficacy data are a few small, old studies: a pilot phase 1 study in 3 male volunteers that showed tanning, a crossover trial in 10 men with psychogenic erectile dysfunction, and related work on sexual function. Since then the literature has shifted to harms, with case reports of eruptive moles, melanoma, systemic toxicity, priapism, and kidney injury, plus laboratory analyses of black-market vials. A 2017 review concluded that illegal melanotans carry risks from unknown preparation, dosing, and administration on top of the melanocytic changes. No controlled safety study of modern products exists.
The core unknown is whether the compound itself, the contaminants in unregulated vials, or the sun exposure users seek is responsible for each reported harm, since all three travel together. Whether repeated melanocyte stimulation raises melanoma risk over years has never been studied prospectively, and the case reports cannot prove causation. Nothing is known about long-term effects on appetite, blood pressure, or the kidney. Regulators note that buyers have no way of knowing what the vials contain, regardless of the label.