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Small Phase 1 human study
Melanotan II is an investigational alpha-MSH analog that is not FDA-approved; this page covers what it is, its regulatory status, the limited Phase 1 evidence, and the safety concerns the FDA has flagged — separate from the reconstitution calculator.
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Melanotan II: reference record
| Regulatory status | Not FDA-approved; FDA lists significant compounded-product safety concerns |
|---|---|
| Route | Subcutaneous |
| Dosing frequency | Daily in short Phase 1 protocol |
| Published range | 0.01–0.025 mg/kg |
| Evidence basis | Small Phase 1 human study |
| Common vial sizes | 10 |
Sources
- DOI 10.1016/0024-3205(96)00160-9Basis for the regulatory status, route, frequency and published range in the table above. Source last checked 2026-06-24
What is Melanotan II?
Melanotan II is an investigational analog of alpha-melanocyte-stimulating hormone, studied in a very small early-phase setting for its effect on skin pigmentation. It has no marketed product and is widely sold outside any regulated supply chain.
Is Melanotan II FDA-approved?
No. Melanotan II is not FDA-approved, and the FDA has published significant safety concerns about compounded products containing it. There is no approved indication, product or labeled use anywhere.
How is Melanotan II given?
The small Phase 1 protocol used a subcutaneous route on a short daily schedule. That protocol was conducted under supervision and does not constitute an approved or validated regimen.
What are the known safety concerns with Melanotan II?
This is the highest-risk entry in this library. The pilot study included only three participants, and nausea, somnolence and prolonged erections were observed. The FDA cites serious case reports, and published harms associated with this substance include melanoma, priapism and rhabdomyolysis.
Pilot began at 0.01 mg/kg and escalated; 0.025 mg/kg proposed for future Phase 1 studies
Study context only; no default clinical dose.
Only 3 participants in the pilot; nausea, somnolence and prolonged erections occurred. FDA cites serious case reports.
Supply-chain quality · Finnrick
Avg quality score
6.7
/10
Purity range
97.66
–
99.95
%
Qty divergence
±
60
%
Vendors · samples
34
·
144
Common vial sizes
10
mg
Test window
Feb 2025 - May 2026
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