PT-141 — Research Overview

Research Overview

PT-141 is also known as bremelanotide. Research has examined melanocortin pathways and sexual-response endpoints. The strongest clinical evidence discussed here relates to a defined population studied with a specific medicinal formulation. [1][2]

What the Compound Is

A synthetic cyclic peptide with melanocortin-receptor agonist activity. Central receptor signaling is relevant to its research context; the mechanism of clinical benefit is not fully established. [2]

Regulatory or Investigational Status

FDA approved Vyleesi, a bremelanotide medicine, for acquired, generalized hypoactive sexual desire disorder in premenopausal women meeting specific criteria. That approval does not cover an AUVYRON 10 mg research vial. [2][3]

Mechanisms or Pathways Under Investigation

Melanocortin-receptor activity is investigated in relation to central sexual-response pathways. Receptor activity should not be equated with guaranteed desire, arousal or performance in an individual. [2]

Major Research Context

The two RECONNECT phase 3 trials studied premenopausal women with hypoactive sexual desire disorder. Their results should not be generalized to men, all forms of sexual difficulty or people outside the enrolled population. [1][2]

Published Research Highlights

Human randomized trials · RECONNECT

The studies reported improvements in desire and related distress scores compared with placebo. Nausea, flushing and headache occurred more frequently with bremelanotide. [1]

Open-label follow-up · Selected participants

An extension study followed participants who completed the core trials. Its uncontrolled design and participant selection limit interpretation of longer-term effects. [4]

Evidence Level and Research Limitations

Outcome scales, study eligibility and placebo effects influence interpretation. FDA labeling discusses transient blood-pressure increases, nausea and hyperpigmentation, among other limitations. Trial findings and the approved product’s safety information do not establish equivalence of a research vial. [1][2][4]

Selected Scientific References

Kingsberg et al. Bremelanotide: two randomized phase 3 trials. Obstetrics & Gynecology, 2019. ↗Human randomized trials
FDA. Vyleesi prescribing information, 2020. ↗Official regulatory material
FDA. Vyleesi approval letter, 2019. ↗Official regulatory material
Simon et al. Long-term safety and efficacy of bremelanotide. Obstetrics & Gynecology, 2019. ↗Open-label human extension study

Educational and Research Disclaimer

This page is for educational and scientific-reference purposes. It does not provide medical advice, diagnosis, treatment recommendations, dosing guidance or instructions for human use. References concern the specific materials and conditions studied; they are not evidence that an AUVYRON product has been evaluated in those studies. Product presentations are catalog identifiers, not use instructions.

FOR RESEARCH USE ONLY. NOT FOR HUMAN OR VETERINARY USE.