PT-141 (bremelanotide)
The one peptide on this site approved for sexual desire. Two phase 3 trials support it for premenopausal women with low desire; the benefit they measured was modest and nausea was common.
- U.S. status
- FDA-approved
- Vyleesi (bremelanotide) injection, NDA 210557, approved June 21, 2019 for acquired, generalized hypoactive sexual desire disorder in premenopausal women.
- FDA source, read September 2026.
- Evidence cited here
- Sexual health: Large trials1 randomized trial of 1,000 or more people cited here for sexual health.
- Forms sold
- Injection · Oral · Sublingual · Nasal spray
1. What PT-141 (bremelanotide) is
PT-141 is the research name for bremelanotide. The FDA approved it in 2019 as Vyleesi, an injection taken as needed before sex, for acquired, generalized hypoactive sexual desire disorder in premenopausal women.
That approval is narrow. It covers low sexual desire that causes distress, in women who have not gone through menopause. It does not cover men, postmenopausal women, or arousal problems with another cause.
2. How it works
Bremelanotide activates melanocortin receptors, a family of receptors in the brain involved in appetite, skin pigment and sexual behavior. Unlike drugs for erectile dysfunction, it does not act on blood flow; it is thought to act on desire pathways in the brain.
How that turns into more desire in a person is not fully mapped. The same receptor family explains two known side effects: nausea, and darkening of skin patches with repeated daily dosing.
3. What the studies measured
The two RECONNECT trials randomized 1,267 premenopausal women with low sexual desire to 1.75 mg under the skin as needed, or placebo, for 24 weeks. Desire scores rose 0.35 points more than on placebo, on a scale that runs from 1.2 to 6. Distress about low desire fell 0.33 points more than on placebo.
Across the phase 3 trials, 40.0% of women on bremelanotide reported nausea, against 1.3% on placebo. Flushing affected 20.3% and headache 11.3%. Nausea was the most common reason for stopping.
An earlier dose-finding trial in 327 premenopausal women found 0.7 more satisfying sexual events a month at the two higher doses, against 0.2 on placebo.
4. What they did not measure
The trials measured a small average change on questionnaire scores. They cannot tell any one reader whether her desire will change enough to notice.
Studies in men were early, single-dose studies of erections under lab conditions. No trial has established PT-141 for erectile dysfunction, and it is not approved for it.
The approval is for Vyleesi at 1.75 mg. Compounded PT-141 sold online is not the approved product and was not what these trials tested.
The studies behind this page
The evidence label above is computed from these papers: their design and how many people they enrolled.
- Randomized trial
1,267 people
Counts toward: Sexual health
Desire score +0.35 and distress score −0.33 against placebo (integrated), both P<.001.
Premenopausal women with hypoactive sexual desire disorder; 1.75 mg subcutaneous as needed, or placebo, for 24 weeks.
Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA (2019). Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. PMID 31599840
- Pooled trial analysis
1,247 people
Counts toward: Sexual health
Nausea 40.0% vs 1.3%, flushing 20.3% vs 1.3%, headache 11.3% vs 1.9%; nausea was the most common reason for stopping.
The integrated double-blind phase 3 population, within a program of 3,500 subjects across 43 studies.
Clayton AH, Kingsberg SA, Portman D, Sadiq A, Krop J, Jordan R, Lucas J, Simon JA (2022). Safety Profile of Bremelanotide Across the Clinical Development Program. J Womens Health (Larchmt). PMID 35147466
- Randomized trial
327 people
Counts toward: Sexual health
+0.7 against +0.2 satisfying sexual events a month for the pooled 1.25 and 1.75 mg doses (p = 0.018).
Premenopausal women with female sexual dysfunctions; 0.75, 1.25 or 1.75 mg as desired, or placebo, for 12 weeks.
Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ (2016). Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Womens Health (Lond). PMID 27181790
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PT-141 (bremelanotide)
Frequently asked questions
- Is PT-141 FDA-approved?
- Bremelanotide, the drug PT-141 names, is FDA-approved as Vyleesi for acquired, generalized hypoactive sexual desire disorder in premenopausal women. Compounded PT-141 sold online is not the approved product.
- How common is nausea on bremelanotide?
- Across the phase 3 trials, 40.0% of women on bremelanotide reported nausea, against 1.3% on placebo, and it was the most common reason for stopping.