Peptide Profile

PT-141

Melanocortin Receptor Agonist

Fda Approved10 sourcesShop PT-141

Overview

Composition

Bremelanotide is a synthetic cyclic heptapeptide melanocortin receptor agonist derived from alpha-MSH analog research.

Mechanism of Action

Acts centrally through melanocortin receptor signaling. The labeled therapeutic effect is not a simple vascular erectile-dysfunction mechanism.

Primary Effects

FDA-approved as Vyleesi for acquired, generalized hypoactive sexual desire disorder in premenopausal women, with important safety language around blood pressure, heart rate, nausea, hyperpigmentation, and cardiovascular contraindications

Discovery & Background

Bremelanotide emerged as a more clinically developed melanocortin agonist after earlier Melanotan II observations around sexual arousal.

Male erectile-dysfunction studies appeared in the 2000s, followed by phase 3 trials in acquired generalized HSDD in premenopausal women and FDA approval of Vyleesi in 2019.

FDA-approved as Vyleesi for acquired, generalized HSDD in premenopausal women; other sexual-function claims remain outside the approved label.

Research Overview

The strongest clinical evidence is the Vyleesi HSDD development program in premenopausal women. Other uses, including male sexual function and general libido enhancement, remain separate research/off-label contexts.

01
Phase 3 HSDD trials support the labeled premenopausal-women indication
02
Trial endpoints focused on sexual desire and related distress rather than generalized performance enhancement
03
Evidence for male sexual-function claims is older, smaller, and not part of the approved label
04
Contraindicated in uncontrolled hypertension and known cardiovascular disease
05
Nausea is common and can be treatment-limiting
06
Hyperpigmentation can occur, especially with more frequent use and in patients with darker skin

FDA-approved for acquired, generalized HSDD in premenopausal women; not approved for broad performance or male enhancement claims

Safety Considerations

Monitoring

Blood pressure and cardiovascular symptoms
Nausea, vomiting, flushing, and dizziness burden
Hyperpigmentation of face, gums, or breasts
Pregnancy status and medication interactions
Whether the patient fits the labeled HSDD population

Side Effects

Common / labeled

Nausea
Flushing
Dizziness or fatigue
Headache
Vomiting

Warnings and contraindications

Transient blood-pressure increases and heart-rate decreases
Contraindicated in uncontrolled hypertension and known cardiovascular disease
Focal hyperpigmentation, especially with frequent use

Contraindications

Uncontrolled hypertension
Known cardiovascular disease
Use outside labeled population without clinician oversight
Pregnancy or breastfeeding unless specifically advised by a qualified clinician

Educational Notice

PT-141 should be discussed as bremelanotide with a specific FDA-approved label, not as a generalized libido or performance peptide. This page is educational and should not replace the official prescribing information or qualified medical care.

References