Hormones & endocrine · Peptide medicine
Also known as bremelanotide, PT-141, Vyleesi
A melanocortin receptor agonist and active ingredient in Vyleesi, approved for a narrowly defined sexual-desire disorder population.[1]
Human studies are available in defined contexts, but the evidence remains product-, population-, route-, or outcome-specific.
Reviewed Jul 22, 2026 · U.S.-focused reference profile
Read the context, not only the compound name. Evidence and status can change with the form, route, population, and use. This profile does not assess individual suitability.
Orientation
Start with identity and research context. Similar names do not establish equivalent products or evidence.
Published research or product contexts. These are not personal indications.
Evidence can change with chemical form, formulation, route, ingredients, and manufacturing. A brand, salt, fragment, or cosmetic ingredient may not represent the same evidence.
What is known
Human studies are available in defined contexts, but the evidence remains product-, population-, route-, or outcome-specific. This is a description, not a rating or recommendation.
Hormone-related and clinician-directed
Randomized clinical trials support Vyleesi for a narrowly defined acquired, generalized hypoactive sexual desire disorder population described in the label. Evidence does not establish use in men, postmenopausal women, or for performance enhancement.
The mechanism of the therapeutic effect is not fully established. Benefit is population-specific, and long-term or repeated-use risks outside the studied label remain uncertain.
Nonclinical melanocortin-receptor pharmacology and toxicology supported development. These findings do not establish outcomes in populations outside the label.[1]
More human evidence does not automatically transfer to a different product, route, population, or purpose. Limited evidence does not prove no biological activity; it means the relevant clinical question is not established by the reviewed material.
What needs caution
Known published concerns and unanswered questions are kept separate so absence of evidence is never presented as reassurance.
Labeled risks include transient increases in blood pressure, reduced heart rate, nausea, headache, flushing, injection-site reactions, and focal hyperpigmentation. The product is contraindicated in certain cardiovascular contexts.
The cited product label describes risks for a specific approved product and use. It is not a complete guide to every product or individual situation.Source [1]The mechanism of the therapeutic effect is not fully established. Benefit is population-specific, and long-term or repeated-use risks outside the studied label remain uncertain.
The answer can change with the product, formulation, route, population, duration, and use being discussed.Source [1]Common effects, important warnings, product-quality concerns, and evidence gaps are different kinds of information. A risk in one product label may not apply to every formulation; an uncertainty proves neither safety nor harm.
Match the product
Form describes the specific product; route describes how it reaches the body. These are sourced descriptions, not instructions.
FDA-approved single-use prescription product for subcutaneous injection in the labeled population.
Routes shown apply only to the named published or investigational formulation; they are not instructions for use.
U.S. product context
At least one FDA-approved product exists, but approval applies only to the named product, formulation, route, population, and use in its label.
Status applies to a product, formulation, route, population, and use. It does not apply to a name in the abstract.
Bremelanotide is FDA approved as Vyleesi for acquired, generalized hypoactive sexual desire disorder in premenopausal women under the full labeled criteria and limitations.
Specific form or route not separately published in this record.View sourceTake it forward
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Each source supports the section that cites it; publication does not imply endorsement or suitability.
VYLEESI prescribing information
DailyMed. VYLEESI (bremelanotide) prescribing information. Revised November 2025.
National Library of Medicine / Cosette Pharmaceuticals · Published Nov 18, 2025 · Accessed Jul 22, 2026 · Prescribing information
Open sourceIdentity, human evidence, laboratory and animal findings, risks, uncertainty, and U.S. product status are shown separately. Missing information stays marked as unpublished instead of being inferred.
