Also known as:PT-141· common/development nameVyleesi· brand name
Hypoactive sexual desir…
Bremelanotide
Evidence levelEstablished clinical
Human evidenceSubstantial
Regulatory statusFDA-approved product exists
What you need to know in 20 seconds
What is it?
Cyclic melanocortin receptor agonist 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.
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.
What the evidence actually supports
✓Strongest conclusion is for the narrow studied/approved HSDD population, not a universal libido enhancer.
✓Anchor the page around the labelled HSDD population rather than internet libido claims.
✓Keep off-label historical evidence separate from approved use.
What is not established / key limitations
×Evidence does not establish general sexual-performance enhancement, male efficacy, or benefit outside the labelled population.
×It is not approved as a general libido enhancer or performance drug.
×Current U.S. label explicitly states Vyleesi is not indicated for men or sexual-performance enhancement.
Selected study & evidence records
RECONNECT Phase III trials of bremelanotide for HSDD
2019 · Two randomized double-blind placebo-controlled trials · n=1267
Bremelanotide significantly improved validated desire and distress endpoints versus placebo.
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.
Route / formulation boundaryResearch-market PT-141 is not automatically equivalent to the authorised Vyleesi product.
Identity / data-quality noteUse the canonical compound identity and studied formulation when interpreting evidence.
Dosing evidence statusVerified dosing evidence added. US licensed dosing. See dosing_evidence records for route, regimen, population, duration and source.
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.
