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Protocol Reference
Bremelanotide (PT-141)

Bremelanotide — approved as-needed protocol

Summarise the as-needed administration protocol established in the RECONNECT phase 3 trials and approved labelling.

FDA Approved for Specific IndicationReviewed September 1, 2026

Research Context

Source of this information
Bremelanotide's approved protocol is event-driven rather than scheduled, which distinguishes it from most peptides discussed in wellness settings.
Evidence level
Grade A — two phase 3 randomised placebo-controlled trials and an approved label
Population studied
Premenopausal women with acquired, generalised hypoactive sexual desire disorder.
Duration studied
24 weeks of double-blind treatment in the phase 3 trials, with open-label extension.
Route reported
Subcutaneous autoinjector, as needed

Protocol as Reported

  • 01Labelling describes a single fixed dose administered as needed at least 45 minutes before anticipated sexual activity.
  • 02A maximum of one dose in 24 hours and no more than eight doses per month are described.
  • 03Labelling advises discontinuing after eight weeks if no improvement in desire or distress is observed.

Adverse Events Reported

  • Nausea, most frequent with the first dose and the leading reason for discontinuation in trials.
  • Flushing, headache, injection-site reactions.
  • Transient blood pressure increase; labelling advises against use in uncontrolled hypertension or known cardiovascular disease.
  • Focal hyperpigmentation with repeated dosing.

Limitations

  • Evidence and protocol apply to a specific diagnosis in premenopausal women.
  • Effect sizes over placebo were modest.
  • Use in men has no approved protocol or adequate trial support.

Sources

  • Prescribing label

    Bremelanotide (Vyleesi) prescribing information

    View Source
  • Randomised controlled trial2019

    Bremelanotide for hypoactive sexual desire disorder (RECONNECT)

    View Study
Read the full PT-141 (Bremelanotide) research guide
Educational reference only. Peptide Atlas does not provide medical advice or individualised dosing guidance, and nothing on this page should be used to guide personal use.