PT-141 (Bremelanotide) Dosage Guide: The Approved Vyleesi Label and Investigational Evidence

PT-141, known by its generic name bremelanotide, is a melanocortin receptor agonist acting through MC3R and MC4R in the central nervous system rather than by changing genital blood flow. As Vyleesi, it is FDA approved at a fixed 1.75 mg subcutaneous autoinjector dose for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). It is not approved for postmenopausal women, men, or pediatric use, and it is not indicated to enhance sexual performance. Earlier development explored an intranasal route in men with erectile dysfunction; that route reached Phase 2 but was never advanced to Phase 3 or FDA approval, and is not the same product as Vyleesi.

The supplied source describes the Vyleesi label dose of 1.75 mg subcutaneous, at least 45 minutes before anticipated sexual activity, no more than one dose per 24 hours and no more than 8 doses per month, alongside the earlier Phase 2 intranasal trials in men that tested 7.5, 15 and 20 mg doses, and community-compounded nasal sprays reported at roughly 1–2 mg per actuation with unverified per-spray delivery.

Only the 1.75 mg subcutaneous Vyleesi dose is FDA approved and tested in Phase 3 trials, and only in premenopausal women with HSDD. The intranasal figures come from an earlier, smaller Phase 2 program in men with erectile dysfunction that was not carried into Phase 3. Compounded nasal sprays are a distinct, non-FDA-approved product with no Phase 3 evidence behind any specific dose.

Neutral research-material planning only. This does not establish an appropriate amount or route.

Routes and amounts are not interchangeable unless a verified study explicitly establishes a conversion.

Published study values describe those studies. Community-reported values are not validated dosing recommendations.

Concentration: 5 mg/mL

1. 1.Vyleesi is dispensed as a prefilled, single-dose autoinjector and does not require reconstitution.
2. 2.For a non-approved research vial: confirm the exact quantity printed on the vial.
3. 3.Choose and record the bacteriostatic water volume; 10 mg into 2 mL gives 5 mg/mL.
4. 4.Clean the stopper with an alcohol swab, then add liquid slowly down the vial wall and swirl gently; never shake.
5. 5.Inspect for cloudiness, color or particles and discard anything that is not clear.
6. 6.Label the vial with the concentration and preparation date.
7. 7.This reconstitution guidance does not apply to the FDA-approved Vyleesi autoinjector and does not establish a research vial as a substitute for it.

Reconstitution does not establish identity, purity, sterility, stability, or an appropriate amount.

• Kingsberg et al. 2019 (RECONNECT), two identical Phase 3 randomized, double-blind, placebo-controlled trials in about 1,200–1,267 premenopausal women, met co-primary endpoints of improved sexual desire and reduced desire-related distress with 1.75 mg subcutaneous bremelanotide on demand for 24 weeks.
• Simon et al. 2019 reported a 52-week open-label extension of RECONNECT in which no new safety signals emerged; nausea, flushing and headache were the most common treatment-related adverse events.
• Diamond et al. 2004 (Phase 1) evaluated intranasal PT-141 in healthy men and men with mild-to-moderate erectile dysfunction, reporting dose-dependent erectile responses at doses above 7 mg and a mean half-life of roughly 1.85–2.09 hours.
• Safarinejad and Hosseini 2008 tested a 10 mg intranasal dose in 342 men who had not responded to sildenafil, reporting improved outcomes versus placebo but more drug-related adverse effects; this remained an investigational, non-FDA-approved use.
• The FDA approved Vyleesi (bremelanotide injection) in 2019 based on the RECONNECT program, specifically and only for premenopausal women with acquired, generalized HSDD.

This is an evidence-gap and precaution list, not an approved prescribing label.