Melanocortin receptor agonist
Bremelanotide
An approved melanocortin medicine for a defined sexual-desire disorder, not a general sexual-performance enhancer.
Also known as PT-141 · Vyleesi · bremelanotide acetate
01 · Evidence profile
One molecule, four evidence questions
Two phase 3 trials support modest changes in prespecified desire and distress endpoints for the labeled population.
Exposure and transient cardiovascular effects are characterized in the approved label.
The label describes blood-pressure effects, contraindications, nausea, pigmentation, and other risks.
High for authentic Vyleesi; evidence does not automatically transfer to compounded PT-141.
02 · Identity
What it is
Bremelanotide is a melanocortin receptor agonist and the active ingredient in Vyleesi. The approved indication has diagnostic, demographic, and exclusion criteria.
03 · Product identity
The molecule is not the finished product.
Vyleesi is an approved, product-specific presentation. Calling any PT-141 product 'Vyleesi' or transferring its evidence to compounded material is not justified.
Vyleesi
September 2020- Formulation
- Single-dose autoinjector
- Route
- Subcutaneous
- Indication scope
- Acquired, generalized hypoactive sexual desire disorder in the premenopausal population and circumstances defined in the label.
- Vyleesi
- Acquired, generalized hypoactive sexual desire disorder in certain premenopausal women
04 · Evidence snapshot
What the evidence can and cannot say
The RECONNECT phase 3 trials reported improvements in prespecified desire and distress endpoints in premenopausal women with acquired, generalized HSDD. The label says it is not indicated to enhance sexual performance.
The evidence does not establish treatment of all causes of low desire, benefit in men or postmenopausal women, universal relationship benefit, or equivalence of compounded PT-141.
05 · Claim check
Three claims under the lens
“Bremelanotide is FDA-approved for a specific form of HSDD.”
Vyleesi is approved for acquired, generalized HSDD in certain premenopausal women after specified exclusions.
- Evidence basis
- Regulatory or product record
- Scope
- The population and limitations in the current Vyleesi label.
“PT-141 is an approved sexual-performance enhancer for anyone.”
The label explicitly says the product is not for enhancing sexual performance and is not indicated for men or postmenopausal women.
- Evidence basis
- Regulatory or product record
- Scope
- Vyleesi's labeled indication and limitations.
“Compounded PT-141 has the same evidence as Vyleesi.”
The trial and approval record are product-specific and do not establish equivalence for compounded material.
- Evidence basis
- Regulatory or product record
- Scope
- Compounded or research-labeled bremelanotide products.
06 · Safety boundary
Before this becomes personal
The label includes a contraindication for uncontrolled hypertension or known cardiovascular disease and describes transient blood-pressure increases. This guide provides no dosing or injection advice.
This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.
Reviewed 2026-07-23. This status is not personal clearance to compete.07 · Sources
Check the primary record
08 · Provenance
Review history
Initial brief based on the Vyleesi label, RECONNECT trials, and FDA multidisciplinary review.
Responsible editor: Anthony Treviso. Editorial source review completed. This page has not been independently medically reviewed by a physician or pharmacist.