PT-141 (Bremelanotide)
Also referenced as: Bremelanotide, Vyleesi, melanocortin receptor agonist
A melanocortin receptor agonist approved for a narrowly defined sexual desire disorder.
- Evidence grade
- AStrong Clinical Evidence
Strong Clinical Evidence
- Regulatory status
- FDA Approved for Specific Indication
Approved in the United States as Vyleesi for acquired, generalised hypoactive sexual desire disorder in premenopausal women. It is not approved for men, for erectile dysfunction or for general libido enhancement, and research-use-only material is not the approved product.
- Human data
- Yes
Registered clinical trials exist
- Last reviewed
- September 1, 2026
Overview
Bremelanotide acts on central melanocortin receptors rather than the vascular pathway targeted by PDE5 inhibitors, which is why it is scientifically interesting: desire, not blood flow.
Community discussion frequently blurs the approved indication with much broader claims. The trials that supported approval were conducted in premenopausal women with a specific diagnosis.
Why It's Being Studied
- Hypoactive sexual desire disorder in premenopausal women.
- Central melanocortin signalling in sexual function.
- Earlier development for erectile dysfunction, which was discontinued.
Mechanism of Action
It acts on brain receptors involved in sexual desire rather than on blood flow to the genitals.
Bremelanotide is a cyclic heptapeptide analogue of alpha-MSH, a non-selective agonist at melanocortin receptors with highest affinity for MC4R and MC1R. MC4R activation in hypothalamic and limbic circuits is implicated in dopaminergic modulation of sexual desire.
Central versus vascular pathways
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Background: Sexual Health Research
Sexual-health peptide research mostly involves the melanocortin system in the brain, which influences desire and arousal separately from blood-flow drugs.
At least one melanocortin agonist has regulatory approval for a narrow indication; related unapproved analogues carry more documented risks.
Research Areas & Routes Studied
- Sexual desire
- Erectile function (discontinued programme)
- Melanocortin signalling
- Subcutaneous injection (autoinjector, approved form)
- Intranasal (earlier development)
Evidence Summary
Two phase 3 randomised placebo-controlled trials supported approval for a specific indication, with a published label.
Higher tiers carry more weight. Filled tiers have evidence for PT-141 (Bremelanotide); tap to read it.
- The RECONNECT phase 3 trials reported statistically significant improvements in desire and reduced distress versus placebo, with modest effect sizes.
- An earlier intranasal erectile dysfunction programme was discontinued after blood pressure findings.
2 cited sources spanning 2019–2019.
- Randomised controlled trial1
- Prescribing label1
Human clinical evidence
- The RECONNECT phase 3 trials reported statistically significant improvements in desire and reduced distress versus placebo, with modest effect sizes.
Clinical trials
- An earlier intranasal erectile dysfunction programme was discontinued after blood pressure findings.
Anecdotal / community information
- Off-label and research-use-only use in men is widely reported and is not supported by approval or adequate trials.
Reported Adverse Events in Research
- Nausea is common and was the leading cause of discontinuation in trials.
- Flushing, headache, injection-site reactions.
- Transient blood pressure increase and heart rate decrease; labelling advises against use in uncontrolled hypertension or known cardiovascular disease.
- Focal hyperpigmentation with repeated use.
Limitations of Current Evidence
- Effect sizes in trials were modest relative to placebo.
- Evidence applies to premenopausal women with a specific diagnosis, not to general use.
How to Read This Research
- Was the compound approved for this population?
- Which validated questionnaire measured outcomes?
- Were nausea, blood pressure and pigmentation changes reported?
- Approved indications are narrow — check sex, menopausal status and diagnosis.
- Unapproved analogues are not equivalent to approved medicines.
- HSDD
- Hypoactive sexual desire disorder, a diagnosed condition.
- MC4R
- Melanocortin-4 receptor, involved in desire and appetite.
Compare With Other Compounds
| PT-141 (Bremelanotide) | Semaglutide | |
|---|---|---|
| Evidence grade | A — Strong Clinical Evidence | A — Strong Clinical Evidence |
| Regulatory status | FDA Approved for Specific Indication | FDA Approved for Specific Indication |
| Human data | Yes | Yes |
| Clinical trials | Registered trials exist | Registered trials exist |
| Research routes | Subcutaneous injection (autoinjector, approved form), Intranasal (earlier development) | Subcutaneous injection, Oral tablet (approved form) |
| Cited sources | 2 | 4 |
Frequently Asked Questions
Documented Research Protocols
Bremelanotide — approved as-needed protocol
Summarise the as-needed administration protocol established in the RECONNECT phase 3 trials and approved labelling.
View documented protocol
Why It Is Used
- Sexual Health
Libido and Sexual Function
One of the few categories where the leading compound is FDA approved — and where its close relative is a clear example of what unselective signalling costs.
Read the case study
Research References
- Randomised controlled trial2019
Bremelanotide for hypoactive sexual desire disorder (RECONNECT phase 3 trials)
Kingsberg SA, et al. · Obstetrics & Gynecology- Main finding
- Improved desire and reduced distress versus placebo; nausea was the most common adverse event.
- Prescribing label
Bremelanotide (Vyleesi) prescribing information