PT-141

Bremelanotide

Evidence & Status

  • FDA Approved
  • Strong Human Evidence
  • Strong

FDA Approval Scope

VYLEESI (bremelanotide) is FDA-approved for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women when the condition is not due to a co-occurring medical or psychiatric condition, relationship problem, or medication side effect; consult current prescribing information for full indication details.

At a Glance

An FDA-approved melanocortin receptor agonist used as VYLEESI for acquired, generalized HSDD in premenopausal women. It acts through central nervous system pathways involved in sexual desire.

Plain English

Bremelanotide works through melanocortin signaling in the brain rather than by directly increasing blood flow. Human Phase III trials support its use for acquired, generalized HSDD in premenopausal women. It has also been explored in other sexual-function research, including studies in men, but those uses are not approved indications.

Overview

Bremelanotide, also known as PT-141, is a melanocortin receptor agonist and the active ingredient in the FDA-approved product VYLEESI. It acts through central melanocortin pathways involved in sexual desire rather than through the vascular mechanism targeted by PDE5 inhibitors. VYLEESI is approved for acquired, generalized hypoactive sexual desire disorder in premenopausal women. Bremelanotide has also been studied experimentally in other sexual-function settings, but those uses are not FDA-approved.

Research Summary

Bremelanotide has strong human evidence for acquired, generalized HSDD in premenopausal women. Two randomized Phase III RECONNECT trials showed significant improvements in sexual desire and reduced distress compared with placebo, supporting FDA approval of VYLEESI in 2019. The approved indication is narrow and does not extend to postmenopausal women, men, or sexual-performance enhancement. Earlier human research explored bremelanotide in male sexual dysfunction, but that evidence should be treated as investigational rather than equivalent to the approved indication.

Research Areas

  • Female sexual dysfunction (HSDD)
  • Male sexual dysfunction
  • Melanocortin pathway CNS
  • Libido modulation

Safety & Risks

Serious Risks

  • VYLEESI transiently increases blood pressure and reduces heart rate after each dose; these effects usually resolve within about 12 hours
  • VYLEESI is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease
  • VYLEESI is not recommended for patients at high risk for cardiovascular disease
  • Focal hyperpigmentation involving areas such as the face, gingiva, or breasts can occur and may not completely resolve after discontinuation
  • Nausea is common and can be severe enough to require anti-emetic treatment or discontinuation

Reported Side Effects

  • Nausea
  • Flushing
  • Injection site reactions
  • Headache
  • Vomiting
United States
FDA-approved as VYLEESI for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women when the condition is not due to a medical or psychiatric condition, relationship problems, or medication/drug effects. VYLEESI is not indicated for postmenopausal women, men, or enhancement of sexual performance.
United Kingdom
Not approved; research only
Australia
Not approved; research only
Canada
Not approved; research only

Citations & Sources