What is it?
Melanocortin receptor agonist
Peptide Library · checked July 16, 2026
Bremelanotide / PT-141
Bremelanotide is not an unapproved peptide in every context. Vyleesi is FDA approved—but narrowly, for acquired, generalized hypoactive sexual desire disorder in certain premenopausal women. That approval does not stretch to general libido claims, sexual performance, use in men, or an unidentified PT-141 product.
EstablishedReplicated relevant human evidence, or approved labeling for the exact use.How labels work →
TL;DR
The lowdown
Four answers first. The source record follows.
What do humans show?
Certain premenopausal women with acquired, generalized HSDD
Where does FDA stand?
Vyleesi is FDA-approved for acquired, generalized HSDD in certain premenopausal women; generic online PT-141 claims are not blanket approval
What is known—and not?
The FDA label contraindicates Vyleesi in uncontrolled hypertension or known cardiovascular disease. It describes transient blood-pressure increases and heart-rate reductions after administration, focal hyperpigmentation, and nausea. Pregnancy precautions also appear in the label.
U.S. status · July 16, 2026
Approval, compounding, product, sport.
- FDA approval
- Vyleesi is FDA-approved for acquired, generalized HSDD in certain premenopausal women; generic online PT-141 claims are not blanket approval
- U.S. federal record
- Vyleesi is FDA-approved for acquired, generalized HSDD in certain premenopausal women; generic online PT-141 claims are not blanket approval
- Product identity
- Reviewed named-product record: Vyleesi.
- Sport
- No WADA status recorded in the reviewed source.
This reports the dated federal and sport record. It does not determine whether a particular product or transaction complies with state or federal law, and it is not legal advice.
01
What it is
Bremelanotide is the active ingredient in Vyleesi, an FDA-approved prescription injection. “PT-141” is commonly used online as a broad consumer label, but approval attaches to the identified drug product, its manufacturing controls, labeling, and studied use.
02
What humans actually show
- FDA labeling limits the indication to premenopausal women with acquired, generalized HSDD that causes marked distress or interpersonal difficulty and is not explained by another condition, relationship problem, or medication.
- The label explicitly says the product is not indicated for postmenopausal women or men and is not indicated to enhance sexual performance.
- This is a meaningful example of why “the molecule is approved” can be misleading. The actual approval is narrower than the viral claim.
03
FDA and U.S. status
Vyleesi is FDA-approved for acquired, generalized HSDD in certain premenopausal women; generic online PT-141 claims are not blanket approval
04
Risks and warning limits
The FDA label contraindicates Vyleesi in uncontrolled hypertension or known cardiovascular disease. It describes transient blood-pressure increases and heart-rate reductions after administration, focal hyperpigmentation, and nausea. Pregnancy precautions also appear in the label.
Those facts describe the approved product's evidence and labeling. They do not establish the contents or safety of an unrelated online vial.
PepCurrent does not provide dosing, sourcing, or personalized sexual-health advice.
05
What would change this answer
- Updated FDA labeling and postmarketing safety information
- Online claims that erase the approved population and indication
- Product-identity confusion between Vyleesi and gray-market “PT-141”
- Better evidence in populations not covered by the approval
06
Sources and records
Educational journalism only; not medical advice. We do not evaluate individual products or link vendors.
What changed
Added the source-verified Claim Check to the structured claim/source/change registry.
What would change our answer
A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.
Version history · 1 entry
- v1 · 2026-07-16Initial structured record created from the reviewed Claim Check.Source ↗
Boundary: PepCurrent explains public evidence and regulatory records. We do not evaluate individual products, recommend use, name vendors, or provide protocols.