PT-141

Approval status

The FDA approved bremelanotide (Vyleesi) in 2019 for premenopausal women with acquired, generalized hypoactive sexual desire disorder. It is not approved for men, for women after menopause, or to enhance sexual performance. The approved product is a single-dose prefilled autoinjector; powder sold in vials as PT-141 is not that product.²

What it’s used or studied for

• Approved use

  Hypoactive sexual desire disorder (acquired, generalized) in premenopausal women.²³

• Human studies

  Erectile dysfunction in men, in small early trials, including men who did not respond well to sildenafil. Not approved for men.⁴⁵

• Human studies

  Appetite and body weight, in two small short trials in women with obesity that found modest weight loss.⁶

Each label shows how strong the evidence is: an approved use, human studies, animal or lab studies only, or a popular claim with no published studies. Being studied is not the same as being proven safe or effective.

Side effects

From the Vyleesi label. In the main trials, 40% of users had nausea and 13% needed anti-nausea medicine. Skin darkening affected about 1% and was more likely in people with dark skin.²

Cautions

• Not for people with uncontrolled high blood pressure or known heart disease, and not recommended for those at high risk of heart disease.²
• The label warns that using it more often or too close together may raise blood pressure more.²
• It may slow stomach emptying and reduce absorption of oral medicines. Avoid it with oral naltrexone used for alcohol or opioid addiction.²
• The label advises effective contraception and stopping it if pregnancy is suspected.²