FDA
No application listedNo application naming melanotan as an active ingredient is listed in Drugs@FDA. Checked 2026-10-05; the control lookup (semaglutide) returned 6 applications.
Drugs@FDA via openFDAMelanotan II: chemistry, literature and regulatory status
Research-use information. This page summarises published literature and regulator records. It is not guidance for use, not medical advice, and not a statement that any material is suitable for use in people or animals.
What is Melanotan II?
Melanotan II is the lactam-bridged cyclic heptapeptide Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2, an analogue of alpha-MSH(4-10) that is a potent, non-selective agonist at human melanocortin receptors. It has no marketing authorisation recorded in the databases checked (see regulatory status). It is supplied here as a research material for laboratory use only.
What are the chemical facts for Melanotan II?
- Name
- Melanotan II
- Also written
- Sequence
- Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2
- Length
- 7 residues
- Molecular formula
C50H69N15O9(matches the formula computed from the sequence)- Average molecular weight
- 1024.2 g/mol
- CAS number
121062-08-6(confirmed in PubChem)- PubChem
- CID 92432
Chemistry checked against PubChem on 2026-10-05. Where the formula can be computed from the listed sequence, it was, and the two routes agree.
How does the literature describe the mechanism of Melanotan II?
- A 1996 pilot phase I study evaluated melanotan-II in a small group of healthy volunteers.[3]
- A 2022 medicinal-chemistry paper replaced the lactam cyclisation of melanotan II with scaffold chemistry and profiled functional selectivity at human melanocortin receptors.[1]
- A review covers the physiology of the melanocortin system: receptors, POMC-derived agonists and endogenous antagonists.[2]
Receptor and pathway background: Melanocortin receptors.
What has published research on Melanotan II looked at?
3 studies are cited for Melanotan II. Each is labelled by design below, and each entry says what the paper measured.
- 1 chemistry
- 1 review
- 1 human study
PubMed returns 624 records for the search terms published on the method page (32 of them with a review publication type, 7 with a clinical-trial publication type), checked 5 October 2026. ClinicalTrials.gov lists 1 registered studies whose intervention matches the name (1 interventional), checked 5 October 2026.
Studies are listed by what they measured. Papers whose titles state an amount or schedule, or describe a clinical outcome of an approved medicine, are not listed. This is a wording rule, not a quality filter; see the method page.
What is the regulatory status of Melanotan II?
EMA
No centrally authorised medicine listedNo centrally authorised procedure in the EMA medicines database (checked 5 October 2026) names melanotan as an active substance. National authorisations are not in this dataset.
EMA medicines dataMHRA
No product document foundNo SmPC, PIL or PAR document in MHRA Products matches the exact name "melanotan". Checked 2026-10-05; the control lookup (semaglutide) returned 271 documents.
MHRA ProductsWADA
Not namedThe WADA 2026 Prohibited List, in force 1 January 2026 does not name this substance. The list names substances by example, so this is not a statement that it is permitted in sport.
WADA Prohibited List 2026A regulator record is information about a database entry. It is not advice and not a statement that any use is lawful or unlawful in any country. How regulators approach research peptides.
Data dates: regulatory records 2026-10-05; WADA list 2026-10-05.
Which studies are cited for Melanotan II?
[1] Tomassi S, Dimmito MP, Cai M, D'Aniello A, Del Bene A, Messere A, et al.. CLIPSing Melanotan-II to Discover Multiple Functionally Selective hMCR Agonists. J Med Chem. 2022;65:4007-4017.
Replaced the lactam cyclisation of melanotan II with scaffold chemistry and profiled functional selectivity at human melanocortin receptors.
[2] Cone RD. Studies on the physiological functions of the melanocortin system. Endocr Rev. 2006;27:736-49.
Review of melanocortin system physiology: receptors, POMC-derived agonists and endogenous antagonists.
[3] Dorr RT, Lines R, Levine N, Brooks C, Xiang L, Hruby VJ, et al.. Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study. Life Sci. 1996;58:1777-84.
Pilot phase I study of melanotan-II in a small group of healthy volunteers (1996).
Data dates: citations read from PubMed 2026-10-05.
Where else in the research library is Melanotan II covered?
Who wrote this page and how is it checked?
Peptency editorial team, last reviewed 5 October 2026. Citations are read back from PubMed, chemistry is checked against PubChem, and regulator records are read from each regulator's own database on the dates shown. The method page lists every source, search term and rule. Corrections are welcome through the contact details on the About page.