PT-141 (bremelanotide) is a melanocortin-receptor agonist studied for sexual dysfunction. Unlike most compounds on this list, an approved version exists: the FDA approved bremelanotide (brand name Vyleesi) for hypoactive sexual desire disorder in premenopausal women.
FDA-approved (as Bremelanotide/Vyleesi)
PT-141 was the research code name; bremelanotide is the same molecule, FDA-approved in June 2019 as Vyleesi for hypoactive sexual desire disorder (HSDD) in premenopausal women — the first on-demand-use treatment approved for this condition. This gives it real, large-scale Phase 3 human trial data.
Benefits
Bremelanotide activates melanocortin-3 and melanocortin-4 receptors (MC3R/MC4R) in the hypothalamus and limbic brain regions — a central-nervous-system mechanism, distinct from erectile-dysfunction drugs that act on blood vessels directly.
Two identical Phase 3 RCTs, "RECONNECT" (n=1,267 total, 1,247 safety population, 24 weeks, 1.75mg subcutaneous as-needed): significant improvement in both co-primary endpoints — sexual desire (P<.001 in both trials) and related distress (P<.001 and P=.005). Kingsberg et al., Obstet Gynecol, 2019
Dosage
FDA-approved dose: 1.75mg, subcutaneous, as-needed, roughly 45 minutes before anticipated activity — not a scheduled daily dose.
Side Effects
Nausea, flushing, and headache each occurred in 10% or more of patients (more than placebo) across both trials — the most common tolerability issues. Overall safety profile was described as favorable, with most events mild to moderate.
Is PT-141 FDA-approved?+
Bremelanotide is FDA-approved under the brand name Vyleesi, for a specific indication in premenopausal women. Research-labeled PT-141 sold outside that approved product is not the approved pharmaceutical and has not gone through the same quality review.
What is PT-141 researched for?+
Sexual arousal and desire, in both men and women, via melanocortin receptor activation rather than the vascular mechanism used by PDE5 inhibitors.
Does PT-141 affect blood pressure?+
Transient blood pressure and nausea effects are commonly reported in the clinical literature for bremelanotide; anyone considering it should be aware this is an active area of the studied safety profile.
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