Legal status, what it is, and the listed suppliers in the United States that list it.
Legal status in the United States
Approved medicine. The FDA label for Vyleesi states it is indicated for the treatment of premenopausal women with acquired, generalised hypoactive sexual desire disorder that is not due to a co-existing medical or psychiatric condition, relationship problems, or the effects of a medication or drug substance.
PT-141, or bremelanotide, is a synthetic peptide that activates melanocortin receptors, developed out of research on analogues of alpha-melanocyte-stimulating hormone. It is an approved medicine in the United States, sold as Vyleesi, for one specific indication in women. Its earlier development as a nasal spray for erectile dysfunction in men was not the route that reached approval.
Kingsberg SA, Clayton AH, Portman D, et al. (2019). Obstetrics & Gynecology. human 1,267 premenopausal women with hypoactive sexual desire disorder across two identical phase 3 trials (RECONNECT), randomised, double-blind, placebo-controlled, 24 weeks
Clayton AH, Althof SE, Kingsberg S, et al. (2016). Women's Health. human 327 premenopausal women with female sexual dysfunction (efficacy population), randomised to placebo or one of three bremelanotide groups, 12 weeks
Clayton AH, Kingsberg SA, Portman D, et al. (2022). Journal of Women's Health. review n/a (pooled safety review of 43 completed studies, about 3,500 participants, phases 1 to 3)
Safarinejad MR, Hosseini SY (2008). Journal of Urology. human 342 men aged 28 to 59 with erectile dysfunction not responding to sildenafil, randomised to intranasal bremelanotide or placebo