Cyclic heptapeptide melanocortin receptor agonist
Bremelanotide
An approved cyclic melanocortin receptor agonist. It is the free-acid counterpart of melanotan II, which is unapproved — the two are frequently conflated.
Also listed as: PT-141, Vyleesi
Chemical identity
- Compound class
- Cyclic heptapeptide melanocortin receptor agonist
- Sequence
- Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH
- Molecular formula
- C50H68N14O10
- Molecular weight
- 1025.2 g/mol
- CAS number
- 189691-06-3
- PubChem CID
- 9941379
- Research categories
- Melanocortin analogues, Approved drug substances
United States regulatory status
FDA-approved drug substance
NDA 210557 (VYLEESI)
Marketed in the United States as VYLEESI, an approved prescription product administered by subcutaneous autoinjector.
- VYLEESI, NDA 210557, approved 21 June 2019. Active prescription product.
- Not listed on FDA's Category 2 or withdrawn-nomination compounding tables.
- Not named on the WADA 2026 Prohibited List.
Regulatory status describes how a substance is classified. It is not a safety assessment, and it says nothing about the quality of any particular material.
Evidence overview
2 records in this file
- CLINICAL TRIAL1
- REGULATORY1
Research areas. Approved-drug Phase 3; United States approval.
Publication span. 2019.
Open the evidence fileWhat we know
- FDA-approved as Vyleesi (NDA 210557, 21 June 2019). RECONNECT Phase 3 trials are published.
- Chemically the free-acid counterpart of melanotan II; the two are distinct substances with different regulatory status.
Editorial reading of the records below, labelled as Therapept analysis. How records are built
What remains uncertain
- Nothing in this file extends the labelled indication. Approved-product evidence stays inside the labelled population and presentation.
Sources
Last reviewed 3 September 2026 · Compiled by Therapept Editorial · How these records are built