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PT-141 (Bremelanotide / Vyleesi)

A melanocortin-receptor agonist FDA-approved as Vyleesi for a specific form of low sexual desire in premenopausal women.

OVERVIEW

Bremelanotide acts on central melanocortin pathways involved in sexual desire. Vyleesi is FDA-approved for acquired, generalized hypoactive sexual desire disorder in premenopausal women when the condition is not due to another medical or psychiatric condition, relationship problems, or medication effects.

Proposed Mechanisms

• Melanocortin-receptor agonism • Central nervous system pathways involved in sexual desire and motivation

Potential Applications

FDA-approved use: acquired, generalized hypoactive sexual desire disorder in premenopausal women. It is not indicated for men, postmenopausal women, or enhancement of sexual performance.

Pharmacokinetics

Subcutaneous administration. The source draft cited onset from about 30 minutes to several hours, peak effect at 2–4 hours, duration up to 12 hours, and an approximately 2.5-hour elimination half-life; use current labeling for clinical decisions.

Dosing

Use the current Vyleesi prescribing information. Do not convert the approved product's instructions into a generic PT-141 protocol.

Monitoring

• Blood pressure and cardiovascular risk • Nausea and tolerability • Skin pigmentation changes • Clinical response

Side Effects

• Nausea • Flushing • Headache • Injection-site reactions • Transient blood-pressure increases

Contraindications

Contraindicated in uncontrolled hypertension or known cardiovascular disease; refer to the current product label for complete restrictions and warnings.

FDA/Investigational Status

FDA-approved as Vyleesi only for the labeled indication in premenopausal women. Approval does not extend to men, postmenopausal women, performance enhancement, or compounded versions.

Disclaimer/Notes

Keep the indication narrow and label-specific. Remove claims that it is an approved option for men or for general sexual-performance enhancement.

Clinical Review Status

Clinical + legal review required before publishing

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