PT-141
Bremelanotide / Vyleesi
PT-141 (bremelanotide / Vyleesi) is an FDA-approved melanocortin agonist for HSDD in premenopausal women. It targets CNS receptors influencing sexual desire rather than vascular pathways.
Overview
PT-141, known by its generic name bremelanotide, is a synthetic cyclic heptapeptide derived from Melanotan II. It acts as an agonist at melanocortin receptors MC3R and MC4R in the central nervous system, distinguishing it from vascular-acting medications. Bremelanotide was developed by Palatin Technologies and refined from Melanotan II specifically to target sexual arousal pathways while minimizing broader melanocortin effects like skin pigmentation.
In 2019, the FDA approved bremelanotide under the brand name Vyleesi for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This made it the first melanocortin receptor agonist approved for a sexual health indication and the first FDA-approved on-demand treatment specifically targeting sexual desire rather than vascular function.
Research context
Bremelanotide's development spanned more than two decades. Early research examined intranasal formulations in both male erectile dysfunction and female sexual dysfunction, but the intranasal route was halted by the FDA in 2007 due to observed increases in blood pressure. Development subsequently shifted to subcutaneous injection, which demonstrated a more favorable cardiovascular profile.
Phase 3 clinical trials evaluated bremelanotide in premenopausal women with acquired, generalized HSDD and demonstrated improvements in sexual desire and reductions in associated distress compared to placebo. The medication is administered via subcutaneous autoinjector approximately 45 minutes before anticipated sexual activity. Research has also explored its potential in male sexual dysfunction, though it is not currently FDA-approved for men. Off-label use in men has been reported in clinical practice.
Safety and regulatory framing
FDA-approved (Vyleesi) for acquired, generalized HSDD in premenopausal women
Bremelanotide (Vyleesi) is FDA-approved exclusively for the treatment of acquired, generalized HSDD in premenopausal women. It is a prescription medication that must be obtained through a licensed healthcare provider. The FDA considers it a first-in-class medication.
Use in men for erectile dysfunction or other sexual health indications is off-label and not FDA-approved. Labeled side effects include nausea, flushing, headache, and transient increases in blood pressure. The prescribing information recommends no more than one dose per 24 hours and no more than eight doses per month. Regulatory status varies internationally. Readers should consult a licensed healthcare provider for any treatment decisions.
References
- Kingsberg SA, et al. "Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder." Obstetrics & Gynecology (2019) ↗Obstetrics & Gynecology
- FDA Press Release: Approval of Vyleesi (Bremelanotide) for HSDD (2019) ↗FDA.gov
- Bremelanotide — DrugBank Entry ↗DrugBank
- Clayton AH, et al. "Bremelanotide for Female Sexual Dysfunctions in Premenopausal Women: A Randomized, Placebo-Controlled Dose-Finding Trial." Women's Health (2016) ↗Women's Health
Research information only
Peptide Daily is an informational resource only. Peptide research chemicals are not approved for human use by the FDA unless otherwise noted. Nothing on this site constitutes medical advice. Consult a qualified healthcare provider before using any peptide or research chemical.
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