PT-141 is unusual on this site: it is an approved medicine. Bremelanotide is sold in US pharmacies as VYLEESI, a single-use subcutaneous autoinjector with a label, a fixed dose and two completed Phase 3 trials behind it. So there is a real dose figure to report — and reporting it accurately means reporting what the label says the dose is for, because that is the part that disappears when the figure is quoted elsewhere. This page reports the label and the trials. It does not recommend anything. Our guide to reading a dosing claim sets out what separates a label figure from a convention. How brands appear on this site is set out on our disclosure page.
What the label states
The version reviewed here is the VYLEESI (bremelanotide) injection label published on DailyMed on 2025-11-18 by Cosette Pharmaceuticals, opened on 2026-09-08.
| Item | What the label states |
|---|---|
| Dose | 1.75 mg |
| Route and site | Subcutaneously, via the autoinjector, into the abdomen or thigh |
| Timing | As needed, at least 45 minutes before anticipated sexual activity |
| Maximum frequency | Not more than one dose within 24 hours |
| Monthly ceiling | "More than 8 doses per month is not recommended" |
| Duration of effect | "The duration of efficacy after each dose is unknown" |
That is the entire recommended dosage. There is no titration, no loading phase and no cycle: it is a single fixed quantity taken before an occasion.
The part that gets dropped
The same label carries Limitations of Use, and they are specific. Vyleesi is not indicated for the treatment of HSDD in postmenopausal women or in men, and not indicated to enhance sexual performance. The approved indication is acquired, generalized hypoactive sexual desire disorder in premenopausal women.
Those two exclusions matter here because they describe most of the demand. A 1.75 mg figure quoted on a page selling PT-141 to men for performance is a figure taken from a document that names both of those uses and excludes them. The number is real; the authority it borrows is not transferable.
The evidence behind the number
Bremelanotide has more human evidence than anything else in this cluster. PubMed held 109 records on 2026-09-08, 14 tagged as randomized controlled trials. The pivotal programme is two identically designed Phase 3 studies in premenopausal women, both completed:
| Trial | Design | Participants |
|---|---|---|
| NCT02333071 | Phase 3, efficacy and safety in premenopausal women with female sexual arousal disorder and hypoactive sexual desire disorder | 723 |
| NCT02338960 | Phase 3, the parallel study of the same design | 714 |
A separate line of work is open: NCT06565611, a Phase 2 study of bremelanotide co-administered with tirzepatide in 108 participants, active and not recruiting as of 2026-09-08. It belongs to the obesity programme and has not reported.
What a research vial is not
The 1.75 mg on the label describes a metered dose delivered by a device from a product whose identity, content and sterility are the manufacturer's legal responsibility. A lyophilized vial labelled "PT-141 10 mg" describes what the seller says is in the vial. The two are not the same claim, and the arithmetic that converts one into the other assumes the vial contains what the label says. Our pages on reading a certificate of analysis and on reconstitution cover what that assumption rests on, and the FDA warning-letter record covers what the agency has said to sellers in this market.
What is not known
The label itself states that the duration of efficacy after each dose is unknown. Nothing in the approved programme addresses use in men, use after menopause, or use to enhance performance, so there is no dose figure for any of those and no safety data at any interval. Nothing on this page is a recommendation.
Sources and dates
Opened 2026-09-08: the VYLEESI (bremelanotide) injection label on DailyMed, set id f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf, published 2025-11-18 (Dosage and Administration section 2.1, Indications and Limitations of Use section 1); PubMed record counts through the NCBI E-utilities; the ClinicalTrials.gov v2 API records NCT02333071, NCT02338960 and NCT06565611. Corrections go to the contact page.