Review · United States
Bremelanotide
Reviewed on
Approval and product status
An FDA-approved product exists for a narrow indication
Evidence for Vyleesi does not automatically apply to every PT-141 product. Vyleesi is an approved, product-specific presentation. Calling any PT-141 product 'Vyleesi' or transferring its evidence to compounded material is not justified.
What was measured in people?
- Health results · Moderate
- Two phase 3 trials support modest changes in prespecified desire and distress endpoints for the labeled population.
- Body changes · Strong
- Exposure and transient cardiovascular effects are characterized in the approved label.
A change in a hormone or body signal does not by itself prove a health benefit.
Important limits
This tool is not an independent medical review. It does not recommend treatment.
The label says the product must not be used with uncontrolled hypertension or known cardiovascular disease. It also describes temporary blood-pressure increases. This guide provides no dosing or injection advice.
Still unknown: The evidence does not establish treatment of all causes of low desire, benefit in men or postmenopausal women, a relationship benefit for everyone, or equivalence of compounded PT-141.
This record cannot check a package, seller, batch, or personal treatment. It does not provide sport clearance.
Approval fact checks
“Bremelanotide is FDA-approved for a specific form of HSDD.”
Supported with scope. Vyleesi is approved for acquired, generalized HSDD in certain premenopausal women after specified exclusions.
Applies to: The population and limitations in the current Vyleesi label.
Products in this review
These are selected records, not every product or form.
Vyleesi
- Ingredients and form
- Single-dose autoinjector
- How it enters the body
- Under the skin (subcutaneous)
- Use and people covered
- Acquired, generalized hypoactive sexual desire disorder in the premenopausal population and circumstances defined in the label.
Published label: September 2020
Read the published Vyleesi FDA label (PDF)What the research shows
The RECONNECT phase 3 trials reported improvements in planned measures of desire and distress in premenopausal women with acquired, generalized HSDD. HSDD is a diagnosed form of low sexual desire. The label says it is not indicated to enhance sexual performance.
Read all Bremelanotide fact checksSources used in this review
A source may support some statements, not all of them. Use the links above or this review to see what each source supports.
Show 3 sources
- VYLEESI (bremelanotide) prescribing information
U.S. Food and Drug Administration · Drug label · 2020
Source accessed
- Bremelanotide for HSDD: two randomized phase 3 trials
PubMed · Obstetrics & Gynecology · Randomized trial · 2019
Source accessed
- Vyleesi multidisciplinary review
U.S. Food and Drug Administration · FDA review · 2019
Source accessed