What is Bremelanotide?

The short answer

Bremelanotide, or PT-141, is a lab-made, ring-shaped peptide based on a hormone the body makes. In the US, you need a prescription to get Bremelanotide.

What it is
Ring-shaped peptide that turns on melanocortin receptors in the nervous system.
What people look into
Sexual function

3 sources
Status as of October 4, 2026
How we source
Ellum doesn't sell peptides.

By Ellum EditorialPublished October 6, 2026Updated October 12, 2026AI use

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What it is

Type: Melanocortin receptor agonist (peptide)
Also known as: pt-141
How it works: Ring-shaped peptide that turns on melanocortin receptors in the nervous system.

Regulatory status

FDA-approved (Rx) How we label status

As of October 4, 2026, Bremelanotide is an FDA-approved prescription drug for hypoactive sexual desire disorder in premenopausal women.

See Bremelanotide in the Index →

Federal (FDA): Approved Rx (Vyleesi, NDA210557, 2019)
503A compounding: Approved-drug component (not in any 503A category) (as of May 14, 2026)

US enforcement actions

6 US enforcement actions since 2020.

Actions by US federal and state agencies whose documents name Bremelanotide. Each row links to the government's own document.

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Date	Agency	Action	Document
August 24, 2026	FDA	Warning letter	FDA document, warning letter, August 24, 2026, 1 of 5 that day, on fda.gov
August 24, 2026	FDA	Warning letter	FDA document, warning letter, August 24, 2026, 2 of 5 that day, on fda.gov
August 24, 2026	FDA	Warning letter	FDA document, warning letter, August 24, 2026, 3 of 5 that day, on fda.gov
August 24, 2026	FDA	Warning letter	FDA document, warning letter, August 24, 2026, 4 of 5 that day, on fda.gov
August 24, 2026	FDA	Warning letter	FDA document, warning letter, August 24, 2026, 5 of 5 that day, on fda.gov

Show all 6 enforcement actions

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Date	Agency	Action	Document
March 21, 2020	FDA	Import alert	FDA document, import alert, March 21, 2020, on accessdata.fda.gov

Forms and brands

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Name	Kind	Status	FDA status	As of
Vyleesi	Brand	FDA-approved (Rx)	Approved Rx (NDA210557, 2019; HSDD in premenopausal women)	October 4, 2026

References

Sources as of October 4, 2026