PT-141 (bremelanotide): approved dosage in the US

Not a recommendation, not treatment guidance. This page shows only the dosing in the official product information, with sources. The dose is always decided by the doctor who prescribes the medicine. Fimea warns against using injectable peptides bought online: Fimea warning.

Source of the dosing: Vyleesi (bremelanotide), FDA prescribing information (FDA), date of the text 3/2024 [1]official

Bremelanotide (PT-141) is approved in the United States as Vyleesi (bremelanotide) for premenopausal women with acquired, generalised hypoactive sexual desire disorder (HSDD) [1]official.

Vyleesi (bremelanotide) is not indicated for postmenopausal women or for men, nor to enhance sexual performance [1]official. The dosing in the table comes from the FDA-approved label [1]official.

Dosing in the product information

Dosing in the official product information. Not a recommendation.
Product and stepIndicationDoseFrequencyDurationSource and level
Vyleesi (bremelanotide) Acquired, generalised hypoactive sexual desire disorder in premenopausal women 1.75 mg under the skin As needed, at least 45 minutes before anticipated sexual activity; no more than one dose in 24 hours, more than 8 doses a month not recommended Stop after 8 weeks if symptoms have not improved [1]official

Evidence levels: official = official product information · A = randomised human trial or meta-analysis · B = observational human study or case series · C = animal study · D = cell or laboratory study · E = not peer-reviewed

Notes

The label limits use to one dose in 24 hours because the efficacy of consecutive doses has not been established and the blood pressure effect may add up; more frequent use also raises the risk of focal skin darkening [1]official.

What points the other way or is uncertain

In the phase 3 trials nausea occurred in 40%, 13% needed anti-nausea medicine and 8% stopped because of it; blood pressure rose by up to 6/3 mmHg 2-4 hours after a dose [1]official.

In the RECONNECT trials (1,267 women, 24 weeks) desire increased and distress decreased statistically significantly versus placebo [2]A, but a later analysis judged the effects small and the validity evidence of the measures weak in this patient group; 8 of the 11 registered efficacy outcomes had gone unpublished [3]A.

Focal skin darkening was reported by 1% of those receiving up to 8 doses a month, but by 38% in another study when a dose was taken daily for 8 days [1]official.

More on this

Read the research yourself: sources

  1. U.S. Food and Drug Administration / DailyMed. Vyleesi (bremelanotide) injection, prescribing information. Revised 3/2024 (DailyMed SPL version 1, published 18 Nov 2025), read 12 Oct 2026. DailyMed
  2. Kingsberg SA, et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019;134(5):899-908. PMID 31599840
  3. Spielmans GI, Ellefson EM. Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder. J Sex Res. 2024;61(4):540-561. PMID 36809187

The date is the "Revised: 3/2024" line of the Vyleesi (bremelanotide) label on DailyMed.

Content is general information about research, not medical advice. If you have symptoms, contact a healthcare professional.