Nonselective melanocortin-receptor agonist cyclic heptapeptide
PT-141 is the development name for bremelanotide. VYLEESI is an FDA-approved, ready-to-use bremelanotide autoinjector for a narrow form of distressing low sexual desire in certain premenopausal women. That approval does not establish a general libido, sexual-performance, male erectile-dysfunction, weight-loss, or kidney-disease treatment.
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Depth and confidence summarize the research record—not effectiveness, safety, or a recommendation.
Bremelanotide has dose-ranging, pivotal Phase 3, long-term extension, mechanistic, and investigational human studies plus an approved SubQ product.
Research depth describes how large and mature the overall record is. It does not tell you whether the results were positive.
Two large controlled trials support desire and distress outcomes in defined premenopausal HSDD, while male, obesity, kidney, and broad performance claims remain unapproved or preliminary.
Confidence describes how reliable and consistent the conclusions are. It can be high for one outcome and low for another.
The strongest evidence type shows what the best-supported conclusions are actually based on.
Human findings are more directly relevant than animal or laboratory results, but they still apply only to the populations and outcomes studied.
Route-specific record
These are exposures used in cited research for a specific route and population—not a suggested amount.
Half-life describes how long it takes the measured amount in the body to fall by half. It is not a dosing recommendation.
Evidence can change by administration method. Findings from one route should not automatically be applied to another.
Evidence boundary: Approval applies only to acquired, generalized HSDD in certain premenopausal women and does not establish treatment for men, postmenopausal women, sexual-performance enhancement, obesity, or kidney disease. Powdered materials are not equivalent to the autoinjector. Amounts shown describe cited research exposure—not a dosage recommendation.
Practical starting point
Common goals and questions—not recommendations or promises of benefit.
The overview, studies, and source ledger below explain what supports each label—and where the evidence stops.
What the evidence says
Two randomized Phase 3 trials involving 1,267 premenopausal women with acquired, generalized HSDD, supported by a current FDA label and earlier dose-ranging research.
This is the strongest supported conclusion in the current human evidence—not a summary of every claim made about the compound.
Durability and rare safety with real-world use, generalizability outside the labeled population, and whether preliminary obesity or kidney signals survive full peer review and larger controlled trials.
Keeping the main uncertainty visible prevents an early or promising finding from looking more settled than it is.
The evidence story
Importance shows how much an item changes the evidence story. Quality shows how much confidence the design deserves. A strong negative study can score highly on both.
Importance and quality answer different questions. A rigorous study can be highly important even when it challenges a popular claim.
Current labeling defines VYLEESI as a ready-to-use 1.75 mg SubQ product for one narrow HSDD population and documents nausea, transient blood-pressure effects, pigmentation, and oral-drug absorption boundaries.
The sponsor reported 4.4% weight reduction in the co-administered group versus 1.6% with placebo over the eight-week total period, with more participants reaching selected weight-loss thresholds.
The sponsor reported that 71% of analyzed participants achieved a greater than 30% reduction in urine protein-to-creatinine ratio and 71% had improved or stable estimated filtration rate.
Bremelanotide increased self-reported sexual desire for up to 24 hours and changed activation in brain regions involved in sexual processing.
Bremelanotide improved sexual-desire scores and reduced distress related to low desire versus placebo. It did not significantly improve the number of satisfying sexual events.
Administration and handling
The current label describes VYLEESI 1.75 mg administered subcutaneously with its single-dose autoinjector to the abdomen or thigh as needed, at least 45 minutes before anticipated sexual activity; no more than one dose in 24 hours or eight doses per month is recommended, and the label says to discontinue after eight weeks without symptom improvement. These are prescription-product instructions for the approved population, not a personalized recommendation and not a dose, route, cycle, or conversion for powders, nasal products, or unverified materials. Older studies and investigational programs used their own protocol-defined regimens.
VYLEESI is a sterile, clear 1.75 mg/0.3 mL solution in a single-dose prefilled autoinjector. The current label says to store it at or below 25°C (77°F), not freeze it, and protect it from light. No reconstitution is required. Those instructions apply only to the named product and do not establish identity, sterility, concentration, stability, beyond-use dating, or reconstitution conditions for compounded or vendor-supplied PT-141 materials.
Primary-source ledger
2025-11-13 · NCT02333071; NCT02338960
2025-03-31 · NCT06565611
2024-12-19 · NCT05709444
2024-08-22 · NCT06565611
2023-01-31 · NCT05709444
2022-10-03 · PMID 36189794 · NCT04179734 · DOI 10.1172/JCI152341
2019-10-10 · PMID 31599840 · NCT02333071; NCT02338960 · DOI 10.1097/AOG.0000000000003500
2019-10-10 · PMID 31599847 · NCT02333071; NCT02338960 · DOI 10.1097/AOG.0000000000003514
2016-06-01 · PMID 27181790 · NCT01382719 · DOI 10.2217/whe-2016-0018
2008-03-01 · PMID 18206919 · DOI 10.1016/j.juro.2007.10.063