Melanotan II
Also known as: MT-II, Melanotan 2
Melanotan II is currently not an approved drug for fda-approved drug product.
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A synthetic melanocortin peptide. It is not a component of an FDA-approved drug and has no USP/NF monograph.
Current status
FDA-approved drug product: Not an approved drug; 503A pharmacy compounding: Category 2 — significant safety risk
| Activity | Status | As of | Jurisdiction | Qualification | Sources |
|---|---|---|---|---|---|
| FDA-approved drug product | Not an approved drug | Aug 30, 2007 | United States federal | No FDA-approved application is in effect for Melanotan II. | |
| 503A pharmacy compounding | Category 2 — significant safety risk | Sep 27, 2024 | United States federal | FDA placed Melanotan II in Category 2 of the 503A bulk list. |
What this means
- ✓ FDA-approved drug product: Not an approved drug. No FDA-approved application is in effect for Melanotan II.
- ✓ 503A pharmacy compounding: Category 2 — significant safety risk. FDA placed Melanotan II in Category 2 of the 503A bulk list.
What this does not mean
- ✗ Status in one jurisdiction does not automatically apply elsewhere.
- ✗ An approved active ingredient is not the same as an approved finished product.
- ✗ “Research use” labeling does not make an unapproved drug lawful for human use.
Timeline
FDA places Melanotan II in 503A Category 2
finalUpdated 503A bulk list categorizes Melanotan II as raising significant safety risks.
FDA warning letter for Melanotan II
enforcement action recordedFDA warned Melanocorp that Melanotan II was an unapproved new drug.
Controlling sources
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A
U.S. Food and Drug Administration · Agency list · FDA-2015-N-3534
- FDA Warning Letter to Melanocorp (Melanotan II)
U.S. Food and Drug Administration · Warning letter