How common is flushing and headache with PT-141? Grade A evidence

What the studies show

Flushing 20.3% vs 0.3%; headache 11.3% vs 1.9%; injection-site reactions 13.2% vs 8.4%.

Several well-run randomised trials in people, pointing the same way. You can plan around this. It still says nothing about whether the effect is worth the side effects for you.

1
VYLEESI (bremelanotide injection) US prescribing information — RECONNECT phase 3 studies (NCT02333071, NCT02338960).FDA label, initial US approval 20191,267 premenopausal women across two 24-week trials; efficacy and adverse-event figures on this page come from the label.

In context

PT-141, sold as Vyleesi, is a melanocortin-receptor agonist approved in the United States in 2019 for premenopausal women with hypoactive sexual desire disorder. Two phase 3 trials in 1,267 women found statistically significant but small improvements in desire and distress scores against placebo. Nausea affected 40% of participants and 18% stopped because of side effects. Use in men, and for erectile function, is unapproved and far less studied.

PT-141 is approved (rx, us). Legal status differs by country — see the regulation section or the jurisdiction pages.

Questions

Is PT-141 proven to cause flushing and headache?

Yes, as far as human trials can show it: Phase 3. LYO grades this outcome A.

What studies are behind the grade?

Flushing 20.3% vs 0.3%; headache 11.3% vs 1.9%; injection-site reactions 13.2% vs 8.4%.

Is PT-141 approved for this?

PT-141 is an approved medicine (Approved (Rx, US)); whether this particular outcome is a licensed indication is stated on the compound page's regulation section.

Other outcomes for PT-141

ASexual desire (premenopausal women, HSDD)2 phase 3 RCTs
ASexual distress (same population)2 phase 3 RCTs
CErectile function / use in menEarlier phase 2 work
ANauseaadversePhase 3

Reviewed 2 September 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →