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PT-141

moderate risk

Also: Bremelanotide · Vyleesi

Strong Evidence FDA Approved

Bremelanotide (PT-141) is FDA-approved for hypoactive sexual desire disorder (HSDD) in premenopausal women. Acts centrally on brain melanocortin pathways governing sexual motivation — unlike PDE5 inhibitors which work peripherally. Also used off-label for male ED.

Molecular Weight
1025.2 Da
Formula
C50H68N14O10
Common Dosing
1.75 mg SC (auto-injector) 45 min before anticipated activity. Max 1x/day, 8 weeks between courses
Category
therapeutic
Last Reviewed
2025-01-15

Reported Benefits

Female sexual desire (HSDD)

Strong Evidence 28 studies

Phase III RECONNECT trials: significant increase in satisfying sexual events vs. placebo.

Male ED (off-label)

Moderate Evidence 12 studies

Phase II: effective in ED non-responsive to PDE5 inhibitors via central mechanism.

Mechanism of Action

MC3R and MC4R agonist in the hypothalamus; activates central dopaminergic/serotonergic pathways governing sexual motivation and arousal.

Key Clinical Studies

Simon et al. (RECONNECT) (2019)

Phase III RCT · n=1267

PubMed →

Significant improvement in satisfying sexual events and desire vs. placebo

Central vs. Peripheral Mechanism

PDE5 inhibitors (sildenafil etc.) work peripherally on blood vessels. PT-141 works in the brain — activating hypothalamic circuits controlling sexual motivation. This makes it potentially useful for desire disorders where peripheral treatments fail.

Regulatory Status

FDA Approved

FDA approved as Vyleesi for HSDD in premenopausal women

Safety Profile

Side Effects

  • Nausea (~40%)
  • Flushing
  • Headache
  • Transient BP elevation
  • Hyperpigmentation (chronic use)

Contraindications

  • Cardiovascular disease
  • Pregnancy
  • High CV risk

Drug Interactions

  • Antihypertensives
  • Naltrexone

Primary Uses

Female sexual dysfunction (HSDD)Male erectile dysfunction (off-label)

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Disclaimer: This information is for educational and research purposes only. Not medical advice. Consult a qualified healthcare provider before using any compound.