Bremelanotide is an approved medicine for one specific condition: persistent low sexual desire (HSDD) in certain premenopausal women. That does not prove it works for general libido enhancement, male sexual performance or unapproved products.
Still uncertain: Benefits outside the approved population and indication, and whether unapproved products are equivalent to the authorised medicine.
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What does the evidence mean in simple terms? table
What is it?
Cyclic melanocortin receptor agonist peptide
Entity type
Peptide
Research focus
Hypoactive sexual desire disorder (HSDD)
Human evidence
Two Phase III RECONNECT trials support bremelanotide for acquired generalized HSDD in premenopausal women. Older intranasal studies also reported male ED signals, but that is not the approved indication.
Regulatory status
U.S. Vyleesi is approved for acquired generalized HSDD in premenopausal women; it is not indicated for men or to enhance sexual performance.
Main limitations
General libido/performance enhancement, approved male ED use, or equivalence of non-authorised products.
Safety
Nausea, flushing, headache and blood-pressure effects; contraindications/limitations are product-label specific.
Evidence reviewed
2026-09-18
i
Two Phase III RECONNECT trials support bremelanotide for acquired generalized HSDD in premenopausal women. Older intranasal studies also reported male ED signals, but that is not the approved indication.
Outcome-level evidence
Evidence is not one score.
Each record below answers a narrower question about an outcome, population or context. Evidence status and the study finding are shown separately so strong evidence is not mistaken for a positive effect.
Sexual desire/distress in premenopausal women with acquired generalized HSDD
Human evidence
Phase III human evidence
Context: Approved-indication population
Finding: There is genuine indication-specific efficacy evidence.
Regulatory / scope context: Evidence does not establish general sexual-performance enhancement, male efficacy, or benefit outside the labelled population.
Nausea, flushing, headache and blood-pressure effects; contraindications/limitations are product-label specific.
Nausea, flushing, headache, transient blood-pressure increase/heart-rate reduction and focal hyperpigmentation are important labelled risks. Contraindicated with uncontrolled hypertension or known cardiovascular disease.
WhichPeps does not rely on a single headline study when the evidence base is broader. Primary research, registries, regulators and supporting records are kept distinct.
2structured study records
3outcome records
7linked source records
How to read these counts: they show evidence coverage, not evidence strength. One large, well-designed study can be more informative than several weak or indirect records.
Show supporting and discovery sources
Study pages above contain the records used for public evidence summaries. The links below include supporting, regulatory and literature-discovery sources; a registry or search result is not treated as proof of benefit.
Evidence rule: WhichPeps keeps human, animal, laboratory, regulatory and product/formulation evidence distinct. Common names help people find the page; they do not change the underlying scientific identity.
