Clinical trial· 2019
Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.
Obstetrics and gynecology
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Human outcomesFDA-approved product · narrow indication
PT-141 / Bremelanotide
Bremelanotide; melanocortin receptor agonist
Also indexed as: Bremelanotide · Vyleesi
What this evidence does not tell us
Phase 3 findings apply to premenopausal women with acquired generalized HSDD, not general sexual-performance enhancement or research-grade PT-141 products.
Terms on this page
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7 glossary terms used in this profile
Terms on this page
Unfamiliar word? Open this panel for simple explanations, right here.
7 glossary terms used in this profile
Select a word to see its meaning. You can keep more than one definition open.
Definitions explain the words—not whether a molecule works or is safe. Research education only, not medical advice.
Overview
PT-141 is a research name for bremelanotide, a melanocortin-receptor agonist. The finished product Vyleesi has a specific FDA-approved indication, not a general enhancement indication.
Mechanism of action
Melanocortin signaling
Bremelanotide activates melanocortin receptors; the exact mechanism producing benefit in the approved HSDD indication is not fully understood. Peripheral pigmentation and cardiovascular effects are relevant to safety.
A biological pathway describes a proposed or observed interaction—not necessarily a demonstrated health outcome.
Decode the terminology in our glossaryScientific evidence
How strong is the evidence?
Stronger human evidence · specific uses
- Limited evidence
- Early research
- Human research
- Human outcomesCurrent category
Controlled human trials support specific outcomes in the people studied. That does not prove every claimed use, remove risks or make a treatment right for everyone.
For this research: Phase 3 findings apply to premenopausal women with acquired generalized HSDD, not general sexual-performance enhancement or research-grade PT-141 products.
An editorial guide—not a validated score, a percentage, a safety rating or an approval badge. Regulatory status is separate. More research does not mean fewer risks.
Cell studies
Mechanistic laboratory evidence is not separately assessed in this selected-source summary; see references and their study types.
Animal experiments
Animal evidence is not separately assessed here. Findings in animals must not be interpreted as demonstrated human benefit.
Human observational studies
Associations, biomarker studies and anecdotes cannot establish treatment causality; no observational result is used here to infer clinical effectiveness.
Human clinical trials
Two randomized phase 3 trials assessed acquired generalized HSDD in premenopausal women.
Regulatory evidence
Vyleesi (bremelanotide) is approved for premenopausal women with acquired generalized HSDD under label criteria, not sexual-performance enhancement.
Potential research applications
Sexual-desire outcomes within a narrowly defined clinical indication.
These describe scientific questions, not prescribing recommendations. A research grouping does not establish combination safety or clinical effectiveness.
Explore research by health goalSafety considerations
The approved product is contraindicated in uncontrolled hypertension or known cardiovascular disease. Risks include transient blood-pressure increases, nausea and focal hyperpigmentation.
This is not an exhaustive safety or contraindication list. An absence of reported harm is not proof of safety. Pregnancy, breastfeeding, cancer history, endocrine disease and concurrent medicines can materially change risk. Unregulated preparations add identity, contamination and sterility risks.
Regulatory status · United States
FDA-approved product · narrow indication
Vyleesi (bremelanotide) is approved for premenopausal women with acquired generalized HSDD under label criteria, not sexual-performance enhancement.
Read the official regulatory sourceRegulatory status and evidence strength are different. A nomination for compounding, a clinical-trial registration or a “research use only” label is not approval. International rules vary; consult the current regulator and product label.
Selected literature & source transparency
Matched bibliographic records confirm a publication’s identity, not the validity of every claim. Selected sources are not a systematic literature review.
Continue your own source search
These open search results, not additional verified citations. Trial registration is not evidence that a treatment works.
Three questions worth bringing to your clinician
- Which human outcomes—not just biomarkers—support this claim?
- What established options address my actual health concern?
- What do my medical history and current medicines change about the risks?
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