PT-141 dosage

Label dosing for Vyleesi

Bremelanotide is approved only as Vyleesi, so its label holds the one set of FDA-reviewed dosing directions.⁴ The prescriber decides whether it suits a patient and sets the dose within the label.

Why the label sets these limits

The label says the benefit of a second dose within 24 hours has not been established, and doses close together may add to the rise in blood pressure.¹ Few phase 3 patients used more than 8 doses a month.¹ More frequent dosing raises the risk of skin darkening and lengthens the time each month when blood pressure is raised.¹

Kidney, liver and age

No dose change is advised for mild to moderate kidney impairment (eGFR 30 to 89) or for mild to moderate liver impairment (Child-Pugh A or B).¹ The label advises caution in severe kidney or liver impairment and notes that severe liver impairment was not studied.¹ In severe impairment, nausea and vomiting may be more frequent or severe.¹ Safety and effectiveness have not been established in children or in older adults.¹ These statements come from the March 2024 label. On October 23, 2026, FDA approved an update to the label section that holds them, based on a breastfeeding study, and the new text was not posted on Drugs@FDA as of October 25, 2026.¹⁴⁴

How women used it in the trials

In the phase 3 trials, women could inject up to 12 times a month, but no more than once per 24 hours.¹ The median was 10 injections over the 24-week blinded phase and 12 over the open-label extension.¹ Most women used it two to three times a month.¹ The approved label later set its advice at no more than 8 doses a month.¹

Doses used in published studies

The table lists doses from research studies: who took part, the route and what was tested. These are research conditions, not guidance for any person.

What the dose studies showed

In the 12-week dose-finding trial, the combined 1.25 and 1.75 mg groups gained 0.7 satisfying sexual events a month, versus 0.2 with placebo (p = 0.018).⁹ In the 397-woman monitoring trial, the 1.75 mg dose raised systolic blood pressure about 3 mmHg more than placebo in the 4 hours after a dose, and peak rises usually lasted under 15 minutes.¹⁰ In healthy men, injected doses produced significant erectile responses at doses above 1 mg.¹¹ With daily dosing, darker skin patches appeared in 38% of participants after 8 days (label) and in more than one third after up to 16 consecutive days (development program review).¹¹² These were safety tests, not treatment schedules.

Reading dose figures

Dose figures across these sources are not directly comparable. The label dose counts bremelanotide itself: 1.75 mg of bremelanotide equals 1.89 mg of bremelanotide acetate.¹ Route matters too. A single 20 mg nasal dose reached peak blood levels about 2.5 times those of the 1.75 mg injection.¹ After an injection under the skin, bioavailability is about 100%.¹

Overdose

No overdoses of Vyleesi have been reported.¹ The label says nausea, skin darkening and larger rises in blood pressure are more likely at higher doses.¹

No human dose outside the label

The label dose comes from trials of the autoinjector in premenopausal women.¹ No dose is approved for men, for postmenopausal women or for enhancing sexual performance.¹ Non-prescription 10 mg vials have no approved application and no FDA-reviewed directions.² A 2026 review of peptides in sexual medicine raises concerns about product quality and dosing variability for melanotan II and related peptides sold through unregulated markets.¹³ For the risks that rise with frequent use, see PT-141 side effects. For the compound itself, see What is PT-141?, and for the trial outcomes, PT-141 benefits and uses. General principles are in Peptide dosage basics.