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Peptide reference

PT-141

PT-141

Human trials

How it works

FDA-approved in June 2019 as Vyleesi for hypoactive sexual desire disorder (HSDD) in premenopausal women. It acts centrally on melanocortin receptors — MC1R, MC3R, MC4R — to modulate dopaminergic signalling. The mechanism bypasses the vascular pathway that drugs like sildenafil target. Off-label interest in men exists; the approved evidence base is in women. Compounding is restricted as it's an approved drug.

FDA status
FDA-approved (NDA 210557) for hypoactive sexual desire disorder in premenopausal women. Brand: Vyleesi. Compounding restricted under FD&C Act.
WADA status
Permitted in sport
Route
subcutaneous injection (approved); intranasal (historical)

Key studies

Safety

Common adverse effects: nausea (40% in trials), flushing, injection-site reactions, transient blood pressure elevation. Contraindicated in cardiovascular disease and high CV risk. Self-administered no more than once per 24 hours.

Frequently asked

  • What is PT-141?

    PT-141, also known as bremelanotide, is a synthetic seven-amino-acid peptide related to a natural hormone that regulates skin pigmentation and, in the brain, sexual desire. Unlike erectile-dysfunction drugs, which increase blood flow to the genitals, PT-141 acts centrally in the brain's melanocortin system, working on desire itself rather than the plumbing.

  • What does the clinical evidence for PT-141 actually show?

    The evidence base for PT-141 is two identical Phase 3 trials in premenopausal women with a diagnosed low-desire disorder; both found a significant improvement in desire and a drop in desire-related distress compared to placebo. No man was enrolled in that Phase 3 program. A long-term safety extension found nausea in about four in ten users, plus flushing and short-lived rises in blood pressure.

  • Is PT-141 approved by the FDA?

    Yes, but only for one narrow use. PT-141 is FDA-approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women. It isn't approved for use in men, for erectile function, or for general libido; that use is off-label and hasn't been tested to the same standard. It's also not on the FDA's PCAC compounding review list, since that pathway is for unapproved substances and PT-141 already has its own approval.

  • Is PT-141 just another erectile-dysfunction drug?

    No, they work on completely different systems. Erectile-dysfunction drugs act on blood vessels, increasing blood flow to the genitals. PT-141 acts centrally, on melanocortin receptors in the brain's desire pathways, upstream of any vascular effect. That's a different lever entirely, and it's exactly why PT-141 draws interest from people blood-flow drugs don't help.

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Research on PT-141

PT-141: The Only FDA-Approved Peptide for Sexual Dysfunction — Approved in Premenopausal Women, Not Indicated in Men

Bremelanotide cleared Phase 3 trials and earned an FDA label for premenopausal women with HSDD. The label is not indicated in men. What that means for the men driving most of the actual demand is an open, unanswered question.