Peptide Graded

PT-141

Is PT-141 safe?

Nausea ~40%; blood pressure effects in trials

BSome human evidenceNot approvedas of 2026-10-26

Nausea is the main side effect. About 40 percent of women in the phase 3 trials reported it, usually after the first doses. Around 8 percent stopped treatment because of it. Flushing, injection site reactions, headache and vomiting are also common. Bremelanotide briefly raises blood pressure by a few mmHg and slows the heart rate for several hours after each dose. The label bars its use in uncontrolled high blood pressure and heart disease. It also caps use per day and per month. About 1 percent of women developed dark patches on the skin or gums, more often with daily use. These did not always fade. Vyleesi also slows stomach emptying and can reduce absorption of oral drugs taken around the same time. None of this safety data covers the gray-market product, whose purity and dose are unverified. It does not cover men either. Only two short 2004 studies exist for them. 135810

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Citations

  1. Dhillon 2019, Drugs: bremelanotide, first approval doi.org
  2. Spielmans 2024, J Sex Res: small effects, questionable outcomes, bremelanotide for HSDD doi.org
  3. Vyleesi (bremelanotide) prescribing information, DailyMed dailymed.nlm.nih.gov
  4. Sildenafil prescribing information, DailyMed dailymed.nlm.nih.gov
  5. Kingsberg 2019, Obstet Gynecol: bremelanotide for HSDD in premenopausal women, two randomized phase 3 trials (RECONNECT) doi.org
  6. Simon 2019, Obstet Gynecol: long-term safety and efficacy of bremelanotide, RECONNECT open-label extension doi.org
  7. FDA Drugs@FDA: Vyleesi NDA 210557 approval record accessdata.fda.gov
  8. Ann Pharmacother 2024: review of bremelanotide for HSDD doi.org
  9. J Clin Invest 2022: crossover fMRI study of bremelanotide in women with HSDD doi.org
  10. Diamond 2004, Int J Impot Res: intranasal PT-141 and erectile response in men doi.org
  11. Rosen 2004, Int J Impot Res: subcutaneous PT-141 in healthy men and men with an inadequate response to sildenafil doi.org
  12. Clayton 2016, Womens Health: bremelanotide phase 2b dose-finding trial in HSDD doi.org

Reference information only, not medical advice. Drawn from the PT-141 article, fact-checked against the cited sources. No dosing anywhere on this site.