Bremelanotide (PT-141): Medicine Overview

Names: PT-141, bremelanotide and Vyleesi

Bremelanotide is the active ingredient. PT-141 is its development code name: a 2006 clinical paper uses the two names together, calling it a melanocortin receptor agonist. [1] Vyleesi is the brand name of one approved injection product that contains bremelanotide. [2] A product sold or advertised under the code "PT-141" is not shown by this page to be the same as Vyleesi: purity, formulation and approval are separate questions. See why similar names do not mean equivalent products.

An agonist is a molecule that switches a receptor on. Bremelanotide activates several melanocortin receptor subtypes; at the levels used in medicine, binding to the MC1R and MC4R receptors is the most relevant. [2] The label states that how it improves desire in women is unknown. [2]

What the trials found

The label describes two identical phase 3 randomized, double-blind, placebo-controlled trials, each with a 24-week core period followed by a longer uncontrolled extension. [2] Together 635 participants received bremelanotide and 632 received placebo. [2] The two co-primary outcomes were the desire score of the Female Sexual Function Index (a 1.2 to 6 scale where higher is more desire) and a distress question about low desire. [2]

The table values come from the label. [2] The label reports both differences as statistically significant. [2] The desire scale runs from 1.2 to 6.0, so the average gains are a fraction of a point. [2]

An independent analysis of the same trials found benefits statistically modest and limited to outcomes with scant validity evidence in women with HSDD. [3] It also reported that 8 of 11 outcomes registered on ClinicalTrials.gov had gone unpublished before its analysis. [3] A 2026 systematic review that pooled treatments for desire, arousal and orgasm problems found that bremelanotide improved total scores plus desire and arousal subscales; it noted no studies compared cognitive behavioral therapy directly with drug therapy. [4]

Label: approved medicine; promising but limited, because the effect is modest and the key measures have been questioned.

A 2008 Journal of Urology trial titled "Salvage of Sildenafil Failures With Bremelanotide" carries a 2023 journal Expression of Concern. [5] The notice text read here did not give reasons; because of the notice, this page does not use that trial's results.

Professional-care context

This is a prescription medicine for a specific diagnosis. The label's definition excludes low desire that is due to another medical or psychiatric condition, relationship problems, or a medication or drug. [2] For the wider topic, see sexual and reproductive health peptide research.

Off-label, compounded and look-alike products

Use in men, postmenopausal women or for performance is outside the label. [2] Melanotan II is a different compound, not Vyleesi; the FDA lists compounded drugs containing Melanotan II as raising immunogenicity concerns. [7] See Melanotan. On the FDA category 2 page read for this guide, bremelanotide did not appear, but that page is not an approval list, so the status of any compounded or online bremelanotide product is not verified here. Animal findings on bremelanotide are preclinical and do not establish human benefit.