PT-141 (Bremelanotide): What It Is and Its U.S. Regulatory Status

What is PT-141?

PT-141 is the development code for bremelanotide, a synthetic peptide that acts on melanocortin receptors in the brain, mainly the MC4 receptor. It was derived from melanotan II, an older research peptide, but it is a different compound with its own approval history.

Melanocortin receptors respond to natural hormones such as alpha-melanocyte-stimulating hormone (alpha-MSH). Different receptor subtypes are involved in skin pigment, appetite and other functions.

U.S. regulatory status

Current status: FDA-approved prescription drug (Rx only).

This means the FDA has reviewed and approved at least one product containing bremelanotide for specific uses, and it can only be dispensed with a valid prescription. The approval covers the approved product itself. It does not extend to unapproved products sold under the same name.

Brand name and approved use

Bremelanotide is approved in the United States under the brand name Vyleesi. It is approved for a specific group: premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The label specifies that the low desire must not be caused by another medical or mental health condition, relationship problems, or a medication.

It is not approved for men or for postmenopausal women, and it is not approved for general use.

How is it accessed?

Vyleesi is available only by prescription from a licensed healthcare provider and is dispensed by a licensed pharmacy. A prescriber reviews medical history, including blood pressure and heart health, before deciding whether it is appropriate.

Products sold as “PT-141” outside the pharmacy system are not Vyleesi and are not covered by its approval.

Why Peptide Labs does not sell PT-141

Peptide Labs does not sell this compound. This page is general information, not medical advice. We do not supply bremelanotide, and we do not point readers to anyone who does.

For personal medical questions, including questions about bremelanotide, the right person to ask is a licensed healthcare provider.

Related reading

See the full list of compound profiles in the Peptide Guide.