PT-141

What is Vyleesi approved for?

Vyleesi is the brand name of bremelanotide, a melanocortin receptor agonist. FDA approved it on June 21, 2019 [4] for premenopausal women with acquired, generalized hypoactive sexual desire disorder, and specifically says it is not indicated for postmenopausal women or men, or to enhance sexual performance [1]. The label dose is 1.75 mg injected subcutaneously with an autoinjector, at least 45 minutes before anticipated sexual activity, with a maximum of one dose per 24 hours and more than 8 doses a month not recommended [1].

What are Vyleesi's main risks and how well did it work in trials?

Two identical 24-week phase 3 trials randomized 1,267 women; bremelanotide raised sexual desire scores and reduced related distress compared with placebo, with more nausea, flushing and headache in 10% or more of users [2]. The label reports nausea in 40% of patients, with 13% needing anti-emetics and 8% discontinuing, plus a transient rise in blood pressure after each dose and focal hyperpigmentation in 1% [1]. It is contraindicated in uncontrolled hypertension or known cardiovascular disease [1].

Is compounded 'PT-141' the same as Vyleesi?

No. Vyleesi is the FDA-approved, reviewed product; anything sold online simply as 'PT-141' is a different, unapproved product that has not gone through that review. Bremelanotide is not on FDA's May 14, 2026 list of nominated bulk substances [3]. Because an approved product exists, the relevant section 503A test is whether the substance is a component of an FDA-approved drug, and whether a given compounded version meets it is a question for the pharmacy and its counsel.