PeptidesInfo

Research area

Sexual health

Sexual health has one clear peptide approval — bremelanotide (Vyleesi) for acquired, generalised hypoactive sexual desire disorder in premenopausal women — with modest effect sizes and notable side effects. Off-label use in men and postmenopausal women is common online but not supported by approval-grade evidence.

Abstract illustration of a peptide chain used as the sexual health research hub image

Evidence map: peptides studied in this area

How grades work →
PeptideEvidence for this areaRegulatory statusWhat has been studied
PT-141Established evidenceFDA-approved for this useFDA-approved (2019) for HSDD in premenopausal women on the basis of the RECONNECT phase 3 trials; effects were modest and nausea was common. Use in men or postmenopausal women is off-label with far less evidence.

Grades reflect the strength of evidence for this research area specifically. Definitions: Established, Promising, Preliminary, Preclinical, Unsupported, Conflicting.

The one approval, and what it actually showed

Bremelanotide acts on melanocortin receptors in the brain rather than on blood flow, which is why it was studied for desire rather than erectile function. In the two RECONNECT phase 3 trials, premenopausal women with acquired, generalised hypoactive sexual desire disorder reported small but statistically significant improvements in desire scores and reductions in distress compared with placebo over 24 weeks. Nausea occurred in about 40% of treated women, and the label warns about transient blood-pressure increases and focal skin darkening.

What is not established

  • Men and erectile dysfunction: early-2000s studies of bremelanotide (then intranasal) in men with ED showed erectile responses, but the programme was halted over blood-pressure concerns and the drug was never approved for men. Online marketing of PT-141 for men draws on those older, small studies.
  • Postmenopausal women: not included in the approval; evidence is limited.
  • "Libido enhancement" in people without a diagnosed disorder: not studied.

Regulatory note

Bremelanotide is a prescription drug in the U.S. Products sold online as "PT-141 for research" are not the approved product, and their identity and purity are not verified — see our analysis of certificates of analysis.

Analyses in sexual health

Research analysis4 min read

PT-141: Mechanism, Approved Use, Benefits, and Limitations

PT-141 (bremelanotide) is FDA-approved as Vyleesi for low sexual desire in premenopausal women, with modest benefits and a lot of nausea. Its use in men — the way it is mostly marketed online — was abandoned in development. Here is what the trials actually showed.