Bremelanotide
VYLEESI
VYLEESI is the FDA-approved bremelanotide prescription product. PT-141 is a name associated with the same active ingredient, but online research vials are not the approved product, presentation, or supply route.
PT-141 appears in the ingredient's development and research-market naming history.
FDA approved the VYLEESI application on June 21, 2019.
The label limits the use to a specifically defined HSDD population.
Shared ingredient naming does not establish product equivalence.
Resolve the application before the claim.
- Brand
- VYLEESI
- Active ingredient
- Bremelanotide
- US application
- NDA 210557
- Company named in current label
- Cosette Pharmaceuticals, Inc.
- Dosage form
- Injection
- Route
- Subcutaneous
- Approval record
- VYLEESI NDA approved June 21, 2019
- Label record updated
- March 2024
What this approval covers - and what it does not.
This summary stays intentionally high level. Use the current full prescribing information for complete warnings, contraindications, adverse reactions, and instructions.
The exact approved record
The current US label covers premenopausal women with acquired, generalized hypoactive sexual desire disorder that meets the label's defined conditions. It is not indicated for postmenopausal women or men, or to enhance sexual performance.
Open current label ↗An ingredient match is not product equivalence
Approval belongs to VYLEESI under NDA 210557 and its exact label and presentation. A seller-labelled PT-141 research vial is not the approved product and cannot borrow VYLEESI's evidence, manufacturing review, indication, or instructions.
Read the category guide →VYLEESI across 42 countries.
This record starts with the exact US FDA medicine identity. The global and state maps keep authorization, presentation, prescription route, market status, pharmacy, and seller records separate.
Compare VYLEESI by country →Compare VYLEESI by US state →The questions behind the medicine search.
Answers are based on the dated FDA and DailyMed records below. They are educational reporting, not a diagnosis, prescription, or treatment recommendation.
Is PT-141 the same as Vyleesi?
PT-141 is a name associated with bremelanotide, the active ingredient in VYLEESI. But a research product sold as PT-141 is not VYLEESI. The approved record belongs to the exact prescription product reviewed under NDA 210557, including its presentation, manufacturing controls, and label.
What is Vyleesi FDA approved for?
The current label covers premenopausal women with acquired, generalized HSDD that meets defined conditions. It is not indicated for postmenopausal women, men, or performance enhancement. The full label contains the complete limitations and safety information.
Why does Peptide Local keep PT-141 prices separate?
The price board records public research-catalog listings, while this page records an approved prescription medicine. Combining them would falsely imply that the same name creates the same product, route to market, evidence, or regulatory status.
Use the current full prescribing information and a licensed clinician or pharmacist for medicine-specific decisions. Do not substitute a research product, investigational program, or unapproved seller listing for an FDA-approved product.
Open safety and verification resources →