Melanotan II: FDA status and clinical evidence

Not FDA-approved, in clinical research

Melanotan II is not approved by the FDA for any use. It appears in the clinical trial registry, so it is under study, which is not the same as being shown to work. 1 study is registered on ClinicalTrials.gov, reaching Phase 2.

FDA-approved

Registered studies

Phase 2

Highest phase

FDA applications

FDA approval status

A search of Drugs@FDA by active ingredient returns no application for Melanotan II. No company has taken it through FDA review, so there is no approved use, no approved dose and no FDA-reviewed label.

Clinical evidence

Registered studies

Interventional

Completed

Currently active

Studies with posted results

Highest phase reached

Phase 2

Total enrolment across studies

By phase

Phase 21

Full trial breakdown for Melanotan II →

Molecular identity

Substance class

Chemical

FDA UNII

UPF5CJ93X7

CAS number

121062-08-6

Recorded synonyms

From the FDA Global Substance Registration System, the registry that assigns every substance the FDA tracks a unique identifier.

How to read this. This page reports what federal records say about Melanotan II, nothing more. An FDA approval covers specific uses and doses on a reviewed label. A registered trial records that research was declared, not that it succeeded. A listed patent governs who may sell a drug, not whether it works. None of this is medical advice, and none of it means a compound is safe to use outside a prescription.

Frequently asked questions

Is Melanotan II FDA-approved?

No. Melanotan II has no approved FDA application. It appears in registered clinical trials, which means it is being studied, not that it has been shown to work or to be safe.

How much clinical research is there on Melanotan II?

1 studies are registered on ClinicalTrials.gov with Melanotan II as an intervention, 0 of them completed. The highest phase reached is Phase 2. Registration counts research activity, not proven benefit.

Where does the information on this page come from?

Four FDA and NIH sources: Drugs@FDA for approval records, the FDA Orange Book for patents and exclusivity, the FDA Global Substance Registration System for molecular identity, and ClinicalTrials.gov for trial counts. Each is refreshed on a schedule and the date above shows the last refresh.

Sources: Drugs@FDA, FDA Orange Book, FDA Global Substance Registration System and ClinicalTrials.gov. Last refreshed 2026-10-16.