Bremelanotide
Reviewed
Short answer
An approved medicine for one defined sexual-desire disorder. It is not a general sexual-performance enhancer. An FDA-approved product exists for a narrow indication.
The Peptide Field explains research. Its pages are not independently medically reviewed, and they do not diagnose, prescribe, or recommend treatment.
Read the study findingsAlso known as PT-141 · Vyleesi · bremelanotide acetate
Part of Melanocortin peptides
Legal status Is Bremelanotide legal? See the status table
Study and product details
What it is
Bremelanotide is the active ingredient in Vyleesi and acts on melanocortin receptors. The approved use has diagnosis, population, and exclusion criteria.
Type of peptide: Melanocortin receptor agonist. This describes what the substance is or how it works. It does not show that it is safe, effective, or approved.
What has been studied?
- Moderate: Useful evidence exists, but important limits remain.
- Strong: Several reliable sources describe this clearly.
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.
Products with the same ingredient can differ.
The ingredient name does not tell you everything about a product. Check its other ingredients, its form, how it enters the body, and the use and people covered by the research or approval.
Vyleesi
September 2020- 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.
- Vyleesi
- Acquired, generalized hypoactive sexual desire disorder in certain premenopausal women
What studies found
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.
Which products do these findings apply to?
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.
Side effects in the Vyleesi label
Vyleesi is the FDA-approved form of bremelanotide, also called PT-141. Its FDA label lists side effects from two 24-week trials in premenopausal women. The women had acquired, generalized hypoactive sexual desire disorder (HSDD), a diagnosed form of low sexual desire.
The most common were nausea, flushing, reactions where the shot was given, and headache. The label says most were mild or moderate and did not last.
Still, 18% of women on Vyleesi stopped because of side effects, compared with 2% on placebo. Nausea was the main reason.
Each number is the share of women in a group who reported the problem during the trials. The label lists problems reported by at least 2% of women on Vyleesi and more often than on placebo. Placebo means a shot with no medicine in it.
Trials in the FDA label
Premenopausal women with HSDD 24 weeks
1,247 women aged 19 to 56 in two matching trials. 627 got Vyleesi and 620 got placebo.
| Reported problem | Vyleesi | Placebo |
|---|---|---|
| Nausea | 40.0% | 1.3% |
| Flushing (warm, red skin) | 20.3% | 0.3% |
| Reactions where the shot was given | 13.2% | 8.4% |
| Headache | 11.3% | 1.9% |
| Vomiting | 4.8% | 0.2% |
| Cough | 3.3% | 1.3% |
| Tiredness (fatigue) | 3.2% | 0.5% |
| Hot flush | 2.7% | 0.2% |
| Tingling or prickly skin (paresthesia) | 2.6% | 0.0% |
| Dizziness | 2.2% | 0.5% |
| Stuffy nose | 2.1% | 0.5% |
Source for Premenopausal women with HSDD: Vyleesi prescribing information on DailyMed , label revised .
Nausea
Nausea usually started within an hour and lasted about two hours. It was most common after the first dose, when 21% of women had it. After later doses, about 3% did. 13% of women on Vyleesi took medicine for nausea.
Blood pressure and heart rate
Vyleesi raises blood pressure for a few hours after each dose. In studies, the largest rise was 6 mmHg in the top number and 3 mmHg in the bottom number. The rise peaked 2 to 4 hours after a dose. Heart rate fell by up to 5 beats per minute. These usually went back to normal within 12 hours.
The label says Vyleesi must not be used by people with uncontrolled high blood pressure or known heart or blood vessel disease.
Dark patches on the skin
In the main trials, 1% of women on Vyleesi got dark patches, including on the face, gums, or breasts. No one on placebo did. In another study with daily use for 8 days, 38% got dark patches. People with darker skin were more likely to get them.
The label says it was not confirmed that the patches went away in everyone after stopping.
Liver
One woman in the long open-label part of a trial had acute hepatitis, a sudden liver inflammation. Her liver tests went back to normal 4 months after she stopped. The label says Vyleesi could not be ruled out as the cause.
What these numbers do not show
- The trials included only premenopausal women. The label says Vyleesi is not for men or postmenopausal women and is not meant to improve sexual performance.
- The label says side-effect rates from one medicine's trials cannot be directly compared with rates from another medicine's trials.
- Trials can miss rare harms and harms that take years to appear.
- The product details above may cite an older Vyleesi label. These tables use the current label on DailyMed.
- These numbers describe Vyleesi. They do not describe PT-141 sold online, which is not the FDA-approved product.
Report a side effect
You can report a suspected side effect to the FDA at 1-800-FDA-1088 or through FDA MedWatch . If a reaction feels serious, get medical care first.
Label checked .
Fact checks
3 statements checked. Read what the results mean.
“Bremelanotide is FDA-approved for a specific form of HSDD.”
Vyleesi is approved for acquired, generalized HSDD in certain premenopausal women after specified exclusions.
- What this answer is based on
- Official record or product label
- Limits of this answer
- The population and limitations in the current Vyleesi label.
Sources for this fact check (1)
“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.
- What this answer is based on
- Official record or product label
- Limits of this answer
- Vyleesi's labeled indication and limitations.
Sources for this fact check (1)
“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.
- What this answer is based on
- Official record or product label
- Limits of this answer
- Compounded or research-labeled bremelanotide products.
Sources for this fact check (1)
Questions people ask about Bremelanotide
The Vyleesi label lists nausea, flushing, reactions where the shot was given, and headache as the most common side effects. In its two main trials, nausea was reported by 40.0% of women on Vyleesi and 1.3% on placebo. Vyleesi also raises blood pressure for a few hours after a dose. Some women got dark patches on the skin. These label numbers do not describe PT-141 sold online.
Risks and safety limits
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.
Reviewed .Check the rules for athletes ↗Terms used in the studies
- indication
- the approved or studied use and patient group
- compounded
- made for one patient by a pharmacy, or in batches by a permitted outsourcing facility; a compounded drug is not FDA-approved
- outcome
- what the study measured
- 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
Read the sources
Show 3 sources
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.
Not independently medically reviewed. This page is not a dosing, sourcing, or treatment guide.
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