An unapproved synthetic alpha-MSH analog promoted for tanning, with published reports of serious adverse events.
Key takeaway
Melanotan II is a cyclic analog of alpha-MSH that activates several melanocortin receptors, affecting skin pigmentation and sexual function.
At a glance
| FDA status | Not FDA-approved |
|---|---|
| 503A compounding | No 503A pathway: nomination withdrawn after FDA safety review |
| Body areas | Skin & hair, Sexual & reproductive health |
| Through ScriptMates | Information only |
| Open questions | None noted |
What is Melanotan II?
Melanotan II is a cyclic analog of alpha-MSH that activates several melanocortin receptors, affecting skin pigmentation and sexual function.
FDA cites published case reports of serious adverse events, including melanoma.
Dosage forms
No FDA-approved dosage form. A standardized dosage form for human use was not confirmed from the sources below.
Is Melanotan II FDA-approved?
Not FDA-approved. Melanotan II was nominated for the 503A bulks list and placed in Category 2 over safety concerns; the nomination was later withdrawn. FDA notes it has no, or only limited, safety information for the proposed uses.
Can it be prescribed through ScriptMates?
No 503A pathway: nomination withdrawn after FDA safety review. No ScriptMates 503A partner pharmacy lists this peptide, so it is shown for information only.
Sources
- FDA: Bulk substances that may present significant safety risks (Category 2 and withdrawn nominations)
- FDA: Bulk drug substances nominated under 503A, Categories 1–3 (May 14, 2026)
Checked October 27, 2026. FDA updates these pages, so confirm before relying on them.