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Dosage Guide · FDA-approved drug (narrow indication)

PT-141 Dosage: What Vyleesi's Label Says

Last updated May 19, 2026 · Reviewed by Grey Peptides Editorial Board · ✓ Based on FDA labeling

← PT-141 encyclopedia entry · See also: Melanotan II dosage · Regulatory tracker

📋 Key takeaways

Bremelanotide is an FDA-approved prescription medicine sold as Vyleesi, approved in 2019 for acquired, generalized HSDD in premenopausal women. The widely used name "PT-141" refers to the same molecule, but most online "PT-141" is sold as an unapproved research powder, which is a different thing from the approved product.

The labeled dose is taken as needed, not daily: 1.75 mg subcutaneously in the abdomen or thigh, at least 45 minutes before anticipated activity, with hard limits of one dose per 24 hours and eight per month.

This page summarizes the label. Community use in men or for general libido is off-label and unstudied at the approval level, and "research" vials are not the verified product.


The short version

Bremelanotide is a melanocortin-receptor agonist that acts in the central nervous system rather than on blood flow, which is what distinguishes it mechanistically from erectile-dysfunction drugs. Unlike most peptides on this site, it crossed the finish line to FDA approval — but for a narrow, specific indication. That makes the dosing story unusually clean on the label side and unusually messy on the community side, where the same molecule is used far outside what was studied.

The FDA-labeled schedule

Per the Vyleesi prescribing information, the dose is 1.75 mg injected subcutaneously into the abdomen or thigh, taken as needed at least 45 minutes before anticipated sexual activity. It is delivered by a single-dose autoinjector — there is no measuring or reconstitution. The label sets explicit ceilings:

ParameterLabel specification
Dose1.75 mg, single use
Timing≥45 minutes before activity
Maximum frequency1 dose / 24 hours
Monthly limit8 doses / month
Route / deviceSubcutaneous autoinjector (abdomen or thigh)
IndicationAcquired, generalized HSDD in premenopausal women

The duration of effect after a dose is not precisely defined in the label, so patients are advised to learn their own response window. The drug is discontinued if there is no improvement after about eight weeks of use.

Side effects that shape dosing

Three points on the label drive how the drug is used. Nausea is common — around 40% of patients, most pronounced with the first dose — which is part of why the medicine is "as needed" rather than daily. Transient blood-pressure increases with a compensatory heart-rate drop occur after dosing, so it is not recommended for people with uncontrolled hypertension or known cardiovascular disease. And because it is a melanocortin agonist, focal hyperpigmentation can occur with repeated use, which is one reason the monthly cap exists.

Where community use departs from the label

Online, "PT-141" is widely discussed for men and for general libido — uses that are off-label and were not part of the approval. Reconstituted "research" PT-141 is dosed by users in widely varying amounts, but this carries the full set of unknowns that come with an unregulated injectable: unverified identity, purity, sterility, and concentration. The approved, verified path is Vyleesi prescribed by a clinician for its labeled indication. For the arithmetic behind reconstituting any lyophilized peptide, see the Reconstitution Calculator — with the caveat that a calculator cannot make an unapproved product safe.

Frequently asked questions

Is PT-141 taken daily?

No. The labeled use is episodic — as needed before activity — with a one-dose-per-day and eight-per-month ceiling. It is not a daily maintenance medicine.

Does it work for men?

The approval is specifically for premenopausal women with HSDD. Use in men is off-label; earlier development in men did not lead to an approved product, in part due to blood-pressure effects.

How fast does it act?

The label's 45-minute pre-dosing window reflects the time to onset; the effect window afterward varies between individuals.


Sources

  1. Vyleesi (bremelanotide injection) U.S. Prescribing Information — FDA, initial U.S. approval 2019.
  2. Bremelanotide — LiverTox / NIH summary of indication, dosing, and adverse effects.
  3. RECONNECT Phase 3 trials of bremelanotide for HSDD in premenopausal women.

Medical disclaimer: Education only, not medical advice. The labeled dose applies to the FDA-approved indication and population; other uses are off-label. "Research" PT-141 is not an approved product. Consult a licensed clinician.