Direct Answer
PT-141 (bremelanotide) is a melanocortin-receptor agonist peptide, FDA-approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women.
Summary Table
Evidence Level
High
AI Summary
PT-141 (bremelanotide) is a cyclic heptapeptide melanocortin receptor agonist. Evidence is high for its approved use: it was approved by the FDA in 2019 (as Vyleesi) for acquired, generalized hypoactive sexual desire disorder in premenopausal women, supported by randomized phase 3 trials (the RECONNECT program) and an earlier dose-finding randomized trial. The most commonly reported adverse events are nausea, flushing, headache, and injection-site reactions; transient blood-pressure increases and focal hyperpigmentation have also been reported. Material sold as unregulated "PT-141" is not the approved product.
Key Information
Classification
Key Takeaways
- PT-141 (bremelanotide) is an FDA-approved melanocortin-agonist peptide (Vyleesi, 2019) for HSDD in premenopausal women
- Approval is supported by randomized phase 3 trials; average benefit is modest
- Common side effects include nausea, flushing, and headache; blood-pressure effects limit some use
Scientific Overview
In Plain English
PT-141, known as bremelanotide (brand name Vyleesi), is an approved prescription medicine that acts on melanocortin receptors. It is approved in the US for a specific type of low sexual desire in premenopausal women and is given by injection under medical guidance. Common side effects include nausea, flushing, and headache. Unregulated "PT-141" sold online is not the approved medicine.
Scientific Details
Bremelanotide (PT-141) is a synthetic cyclic heptapeptide agonist at melanocortin receptors (notably MC4R). It received FDA approval in 2019 for acquired, generalized HSDD in premenopausal women based on two randomized, placebo-controlled phase 3 trials (RECONNECT) and supporting dose-finding data. Reported adverse events include nausea, flushing, headache, injection-site reactions, transient increases in blood pressure and reductions in heart rate, and focal hyperpigmentation with repeated dosing.
How It Works
Bremelanotide is described as an agonist at melanocortin receptors, including MC4R in the central nervous system, a pathway associated with sexual-response signaling. This mechanism is characterized in pharmacology studies and supported by randomized clinical trials for the approved indication.
Mechanism of Action
Melanocortin receptor agonism
human
Bremelanotide activates melanocortin receptors (including MC4R), a central pathway associated with sexual-response signaling.
Evidence Level
Human Evidence
Two randomized, placebo-controlled phase 3 trials (RECONNECT) and an earlier dose-finding randomized trial support the approved HSDD indication; a safety analysis across the clinical development program characterizes adverse events.
Animal Evidence
Preclinical work characterized melanocortin-receptor pharmacology and effects on sexual behavior.
Limitations
Approved efficacy is specific to acquired, generalized HSDD in premenopausal women; benefit is modest on average and not established for other populations or uses. Blood-pressure effects limit use in some patients.
Why This Grade
Graded high for the approved indication: supported by randomized, placebo-controlled phase 3 trials and FDA approval. This grade applies to the regulated product and indication, not to off-label or unregulated use.
References
- Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstetrics and Gynecology.Human Studydoi:10.1097/AOG.0000000000003500 →
- Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Women's Health (London).Human Studydoi:10.2217/whe-2016-0018 →
- Safety Profile of Bremelanotide Across the Clinical Development Program. Journal of Women's Health.Human Studydoi:10.1089/jwh.2021.0191 →
Alternative Names
- Bremelanotide
- Vyleesi
- PT141
Risks & Safety
- Nausea is common and was a frequent reason for discontinuation in trials
- Flushing, headache, and injection-site reactions are commonly reported
- Transient increases in blood pressure and decreases in heart rate occur; it is not recommended in uncontrolled hypertension or cardiovascular disease
- Focal hyperpigmentation (including of the face, gums, and breasts) has been reported, more with repeated dosing
- Material sold as unregulated "PT-141" is not quality-controlled and is not the approved medicine
Claim Boundaries
ION BLUE is an educational research aggregator. This content summarizes published scientific literature. It is not medically reviewed, is not medical advice, and is not a recommendation to use any substance. Some peptides discussed are approved medicines; others are research chemicals not approved for human use. Consult a licensed healthcare provider. Bremelanotide is a prescription medicine; this educational summary is not medical advice and not a recommendation to start, stop, or change any treatment, nor to use unregulated "PT-141".
This page summarizes published research and is for informational purposes only; it is not medical advice.