PT-141 is the development code for bremelanotide. It acts on melanocortin receptors in the brain, rather than on blood flow the way the erectile-dysfunction pills do.
What matters first
Why people look it up
It is bought mostly by men, for erections and desire.
What the evidence shows
That is the one group its label rules out. Vyleesi was approved in 2019 for premenopausal women with low sexual desire. The same label excludes postmenopausal women, and use to improve sexual performance. In the trials behind it, 18% of participants stopped because of a reaction.
Dose status
PT-141 is a prescription medicine, sold as Vyleesi, given as an injection under the skin. The label dose is 1.75 mg. It is taken as needed, at least 45 minutes before sexual activity; no more than once in 24 hours and no more than 8 times a month.
PT-141 at a glance: FDA-approved label, dosing basis, regulatory status, safety coverage, and cited-source count. These details summarize the available sources; they are not treatment recommendations.
Evidence snapshot
FDA-approved label
The fastest way to see what kind of evidence this page is built on.
Regulation
FDA approvedVyleesi
Dose source
Human study1 reported dose row
Safety evidence
14 listed safety findingsCommon and serious effects shown apart
PT-141 at a glance: FDA-approved label, dosing basis, regulatory status, safety coverage, and cited-source count. These details summarize the available sources; they are not treatment recommendations.
Medically reviewed by Jennifer Montecillo, MD · non-practicing medical reviewer·Reviewed 2026-08-12·open the primary sources
What is known about PT-141
PT-141 is the development name for bremelanotide. It received FDA approval in 2019 as Vyleesi for certain premenopausal women with low sexual desire. The approved product is a ready-to-use, single-dose injector holding 1.75 mg in 0.3 mL. It goes under the skin of the abdomen or thigh at least 45 minutes before sexual activity. The label rules out use in men, postmenopausal women, and use to improve sexual performance.
PT-141 research and regulatory details: evidence quality, approval status, doses, handling, and presentation.
Topic
Value
Strongest source
FDA label
FDA approval
Approved (Vyleesi)
Maintenance dosing
1.75 mg as needed, at least 45 minutes before sexual activity; no more than once in 24 hours and no more than 8 times a month— from the FDA-approved label
Typical vials
1.75 mg
Every row links back to a source listed below. These facts are for reference, not a personal recommendation.
What the evidence for PT-141 is
The dosing numbers come from an FDA-approved prescribing label. FDA reviewed the manufacturer’s studies before approving the product, and the label can change when new dosing or safety information appears.
FDA label
What it establishes
The schedule was tested for the approved use, FDA reviewed the results, and the approved product must meet manufacturing standards.
What it does not establish
It does not show that every dose step is right for every person. A clinician still has to consider health history, side effects and other medicines.
Use these numbers for the named product and approved use. A different brand, product form or use may have a different schedule.
Where PT-141 is in clinical trials
10 registered studies; the program has reached phase 4. Studies are running, but none is taking new participants.
Phase 4Completed
Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk
Cosette Pharmaceuticals, Inc. · Lactating Mother · 10 participants · started July 2025
A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)
Kwang Dong Pharmaceutical co., ltd. · Hypoactive Sexual Desire Disorder · 193 participants · started May 2021
Searched under the name bremelanotide, which is how the registry files it.
A registered study means a sponsor filed a plan and started enrolling. It is not evidence the drug works, and most drugs tested in people never reach a pharmacy. Sponsors write and update these sources themselves; the National Library of Medicine publishes them without checking them.
FDA has approved this molecule, but only as Vyleesi.
Vyleesi is a prescription autoinjector holding a ready-made solution. Its label has no powder vial and no reconstitution step anywhere in it. Research-grade PT-141 sold as a lyophilized powder is not that product, and no approved label stands behind it.
The label caps use at one dose in 24 hours. It advises against more than 8 doses a month. It rules the drug out entirely in uncontrolled hypertension or known cardiovascular disease.
Approved only for certain premenopausal women with low sexual desire
Not for people with uncontrolled high blood pressure or known heart and blood-vessel disease
The approved product is a ready-filled injector, not a powder vial
Serious reactions were reported in 1.1% of treated participants and 18% left the trials because of a reaction
The label says to stop after 8 weeks when symptoms have not improved
Questions about PT-141
Is PT-141 FDA-approved?
Yes — it is sold as Vyleesi. That is why the schedule on this site is quoted from a label rather than summarized from a study.
How is PT-141 taken?
By injection under the skin, as needed, at least 45 minutes before sexual activity.
How does PT-141 differ from the other compounds in this class?
PT-141 is an approved medicine, but it is not a GLP-1 or amylin drug. It works through a different system, so its dose and results cannot be compared directly with weight-loss injections.
What is not known about PT-141?
It does not show that every dose step is right for every person. A clinician still has to consider health history, side effects and other medicines.
Questions readers ask
Is PT-141 better than Viagra?
No published trial has set the two against each other. PT-141 is the development code for bremelanotide, approved as Vyleesi for premenopausal women with acquired, general low sexual desire. Its label rules out use in men, in women past menopause, and to enhance sexual performance.
So the two are not pointed at the same person or the same problem. Answering the comparison would need a trial nobody has run.
How long does PT-141 take to kick in?
The label has it injected at least forty-five minutes before expected sexual activity. That is the interval the trials used, rather than a measured onset time.
The label caps use at one dose in twenty-four hours and advises against more than eight doses a month. It also says to stop after eight weeks when symptoms have not improved.
What does peptide PT-141 actually do?
It switches on melanocortin receptors, and the approved product covers one use: acquired, general low sexual desire in premenopausal women. Vyleesi is a ready-filled autoinjector holding 1.75 mg in 0.3 mL of solution.
The label draws its limits plainly. Not for men, not for postmenopausal women, and not for improving sexual performance.
Who should not take PT-141?
This is one of the few questions on this site with a published answer. The label rules the drug out entirely in uncontrolled high blood pressure and in known heart or blood-vessel disease. It also advises against it for anyone at high cardiovascular risk.
Past that, the approved use covers one group only: premenopausal women with acquired, general low sexual desire. Men, postmenopausal women and performance use all sit outside it.
1primary source, each with the day we read it — open the documents used on this page
