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Strong Human Evidence

PT-141 (Bremelanotide)

A melanocortin receptor agonist FDA-approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women.

In plain English

PT-141, also known as bremelanotide and sold as Vyleesi, is a synthetic peptide that activates melanocortin receptors in the central nervous system to influence sexual arousal pathways. It was FDA-approved in 2019 for hypoactive sexual desire disorder (HSDD) in premenopausal women based on the RECONNECT trials. Common side effects include nausea, flushing, and transient increases in blood pressure. PT-141 also has off-label and research interest in men with erectile concerns. It is prescription-only.

What it is

Bremelanotide (PT-141) is a synthetic cyclic heptapeptide and analog of alpha-melanocyte-stimulating hormone (α-MSH). It is a non-selective agonist at melanocortin receptors, with primary activity at MC4R.

Mechanism (summary)

PT-141 activates central melanocortin pathways — particularly MC4R-expressing neurons — that are implicated in sexual arousal and motivation in both sexes.

Why people research it

  • Hypoactive sexual desire disorder in premenopausal women (FDA indication)
  • Erectile function in men
  • Female sexual arousal disorder

Human evidence

RECONNECT-1 and RECONNECT-2 (n>1,200) showed statistically significant improvements in sexual desire and decreases in distress in premenopausal women with HSDD compared with placebo. Effect sizes were modest but consistent.

Animal / lab evidence

Rodent studies of melanocortin agonists support pro-sexual effects in both sexes via central pathways.

Key studies

Each summary explains the design, what was found, and what it doesn't prove.

Human RCT2019·1,247 premenopausal women with HSDD
Efficacy and Safety of Bremelanotide for Hypoactive Sexual Desire Disorder (RECONNECT)

In the FDA pivotal trials, premenopausal women with low sexual desire saw improvements on PT-141 compared with placebo, with nausea as the main side effect.

Finding: Bremelanotide produced statistically significant improvements in sexual desire and decreases in associated distress vs. placebo across two Phase 3 trials.
Limitations: Effect sizes were modest; discontinuations due to nausea were not trivial.
Review2019·Adult women
Bremelanotide for the treatment of female sexual dysfunction

A review of how PT-141 is used and how it compares to other treatments for low sexual desire.

Finding: Reviews efficacy and safety of bremelanotide in HSDD and discusses positioning in clinical practice.
Limitations: Review article.

History

Originally developed by Palatin Technologies. Approved by FDA as Vyleesi in June 2019.

Important:

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