Peptide Lexicon

PT-141 (Bremelanotide): Approved as Vyleesi, and What the Approval Covers

PT-141 is bremelanotide, approved in the US in 2019 as Vyleesi for one specific use in premenopausal women. What the label covers, its stated limitations, and its documented warnings.

FDA approvedPrescription only

Caroline S · Published 2026-09-06

Length

Peptide, melanocortin receptor agonist

Sequence

Bremelanotide

Origin

Acts on MC1R and MC4R at therapeutic doses

Last reviewed

2026-09-06

What is it good for?

One approved use: hypoactive sexual desire disorder in premenopausal women, as a diagnosed condition. The label states it is not for men, not for postmenopausal women, and not intended to enhance sexual performance.

What it is

PT-141 is bremelanotide, a peptide that acts on the body's melanocortin receptors. It activates several receptor subtypes without selecting strongly between them; at therapeutic doses the two that matter are MC1R and MC4R.

Those two receptors explain most of what the drug does and most of what goes wrong with it. MC4R is involved in central pathways relating to sexual desire. MC1R is involved in pigmentation — which is why one of the documented effects is patches of darkened skin.

It is an approved medicine in the United States, marketed as Vyleesi since 2019, and given by subcutaneous injection with an autoinjector.

What it is approved for

The treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder.

Each word in that phrase is doing work. Acquired means the condition developed after a period of normal function. Generalized means it is not confined to particular situations or partners. Premenopausal narrows the population further. It is a specific clinical diagnosis, not a general description of low desire, and the approval is drawn to it exactly.

What the approval explicitly excludes

The label states plainly that bremelanotide is not indicated for postmenopausal women or for men, and that it is not intended to enhance sexual performance.

Both exclusions matter, because both describe how the compound is most often discussed online. Use by men sits entirely outside the approval and outside the trials that supported it. And desire and performance are different things — the label distinguishes them, and writing that treats the drug as a performance enhancer is describing a use nobody has studied under that name.

What the research shows

As with any approved drug, the picture is documented rather than inferred: trials in the stated population, a defined endpoint, and a published side-effect profile.

The warnings are specific and follow from the mechanism. Transient increases in blood pressure. Focal hyperpigmentation, noted particularly in patients with darker skin — a direct consequence of activating MC1R. And nausea in roughly 40% of treated patients, which is a high figure and is stated as such. It is contraindicated in uncontrolled hypertension and in known cardiovascular disease.

A compound that reliably raises blood pressure and changes skin pigmentation is not a mild one. Those effects are in the label because they were measured.

Where it stands

Approved as a medicine: yes, in the United States, since 2019, for the indication above.

Sold also as: a research chemical, under the name PT-141, by vendors not selling the approved product. The approved drug and a research-labelled vial of the same nominal compound are not equivalent things: one carries a label, a manufacturer, a batch record and a regulator behind it.

Last checked

2026-09-06. The prescribing information was read on that date.

What the research shows

Desire in diagnosed HSDD, premenopausal women

Human trials; the basis of the FDA approval

Use by men

Outside the approval; not studied for it

Performance enhancement

The label states it is not intended for this

Bars show how much of the evidence is in humans, not how well anything works.

Where it stands

Approved as a medicine

United States, 2019, marketed as Vyleesi. Subcutaneous injection by autoinjector.

Approved for

Premenopausal women with acquired, generalized hypoactive sexual desire disorder.

Documented warnings

Transient blood pressure increases; focal hyperpigmentation, particularly in darker skin; nausea in about 40% of treated patients.

Contraindicated in

Uncontrolled hypertension and known cardiovascular disease.

Frequently asked questions

What is PT-141?

PT-141 is bremelanotide, a peptide that acts on melanocortin receptors. It activates several receptor subtypes non-selectively, with MC1R and MC4R the most relevant at therapeutic doses. Unlike most compounds in this library it is an approved medicine in the United States, marketed as Vyleesi since 2019 and given by subcutaneous injection with an autoinjector.

What is PT-141 approved for?

The treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder — a specific clinical diagnosis, not a general description of low desire. 'Acquired' means the condition developed after a period of normal function, and 'generalized' means it is not limited to particular situations or partners. That precision is part of the approval.

Is PT-141 approved for men?

No. The label states explicitly that it is not indicated for postmenopausal women or for men. Male use is common in what is written online about this compound; it sits entirely outside the approval, and the trials that supported the approval did not study it.

Does PT-141 enhance sexual performance?

The label states directly that it is not intended to enhance sexual performance. The approved use concerns desire in a diagnosed condition, which is a different thing from performance, and the distinction is written into the prescribing information rather than being a matter of interpretation.

What are the documented risks of PT-141?

Because it is an approved drug, they are written down. The label documents transient increases in blood pressure, focal hyperpigmentation — noted particularly in patients with darker skin — and nausea, which affects roughly 40% of treated patients. It is contraindicated in people with uncontrolled hypertension or known cardiovascular disease. The hyperpigmentation and the blood-pressure effect are direct consequences of what melanocortin receptors do, not incidental side effects.