Evidence brief
Bremelanotide
Written and source-checked by Anthony Treviso, founder of The Peptide Field.
Direct answer
An FDA-approved product exists for a narrow indication.
An approved medicine for one defined sexual-desire disorder. It is not a general sexual-performance enhancer.
- How strong is the evidence?
- Established
An official agency review or strong, repeated studies in people support one clear use. That evidence applies only to the product, people, and use we reviewed. It does not mean the product is safe or effective for everyone. - What evidence exists?
- Approved human outcomes
Approved products have evidence from studies in people that measured health results for specific uses. This does not show that every product, person, or use has the same result. - Sports rules
- Not assessed
No current sports-rule review is available.
Reviewed August 1, 2026. Sources and update notes are below.
No sales or dosing advice. This guide explains research. It was not independently medically reviewed, and it does not diagnose, prescribe, or recommend treatment.
Also known as PT-141 · Vyleesi · bremelanotide acetate
Part of Melanocortin peptides
Words used here
- indication
- the approved or studied use and patient group
- outcome
- what the study measured
- compounded
- made for one patient by a pharmacy, or in batches by a permitted outsourcing facility; a compounded drug is not FDA-approved
- receptor
- a protein in a cell that receives a body signal
- agonist
- a substance that activates a receptor
- amino acid
- a small building block that makes peptides and proteins
- peptide
- a short chain of amino acids
More detailProduct and study details
01 · Evidence profile
Four questions about the evidence
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 the active ingredient in Vyleesi and acts on melanocortin receptors. The approved use has diagnosis, population, and exclusion criteria.
Scientific group: Melanocortin receptor agonist. This group name describes the type of molecule or body signal. It does not prove a benefit, safety, or approval.
03 · Exact product
The molecule is not the finished product.
Formulation: The finished product's ingredients and physical form. Route: How the product enters the body. Indication: The approved or studied use and group of people for a product.
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 · Research results
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.
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.
Exact product
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.
05 · Claim check
Claims I checked
3 claims checked for this brief.
“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 used
- Regulatory or product record. This answer uses an official regulator record or a specific product label.
- Limits of this answer
- The population and limitations in the current Vyleesi label. This answer covers only the named molecule and finished product. It also covers the product form and how people used it. The study limits include who took part, what was used for comparison, what changed, and how long the study lasted.
“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 used
- Regulatory or product record. This answer uses an official regulator record or a specific product label.
- Limits of this answer
- Vyleesi's labeled indication and limitations. This answer covers only the named molecule and finished product. It also covers the product form and how people used it. The study limits include who took part, what was used for comparison, what changed, and how long the study lasted.
“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 used
- Regulatory or product record. This answer uses an official regulator record or a specific product label.
- Limits of this answer
- Compounded or research-labeled bremelanotide products. This answer covers only the named molecule and finished product. It also covers the product form and how people used it. The study limits include who took part, what was used for comparison, what changed, and how long the study lasted.
06 · Questions
Questions people ask about Bremelanotide
An FDA-approved product exists for a narrow indication. Approved products identified: Vyleesi.
Not assessed. This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body. This status is not personal clearance to compete.
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.
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.
07 · Safety
Safety limits for this record
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.
This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.
No current sports-rule review is available.
Reviewed .Check current rules for tested sport ↗08 · Sources
Read the sources
09 · Review history
Review history
Revalidated the Vyleesi indication and limits against FDA labeling. The approved use is limited to certain premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The label says it is not for sexual-performance enhancement.
Initial brief based on the Vyleesi label, RECONNECT trials, and FDA multidisciplinary review.
Written and source-checked by Anthony Treviso, founder of The Peptide Field.
Not independently medically reviewed. This page is not a dosing, sourcing, or treatment guide.