Is Bremelanotide legal in the US?
Yes, FDA approved for low sexual desire in women before menopause.
Bremelanotide is FDA-approved and sold as Vyleesi, a self-administered subcutaneous autoinjector, approved in June 2019 for premenopausal women with acquired, generalised hypoactive sexual desire disorder (HSDD). It is not approved for men or for postmenopausal women. 23
Yes, as Vyleesi, since June 2019. It is for premenopausal women with acquired, generalised hypoactive sexual desire disorder. It is not approved for men or for postmenopausal women. The PT-141 sold by online vendors is an unregulated version of the same peptide. 23
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Citations
- ScienceDirect topics: bremelanotide sciencedirect.com
- Palatin Technologies 2019: FDA approves Vyleesi (bremelanotide injection) palatin.com
- FDA: Vyleesi (bremelanotide) prescribing information, 2019 accessdata.fda.gov
- Kingsberg 2019, Obstetrics & Gynecology: bremelanotide for HSDD, RECONNECT randomized trials doi.org
- Journal of Sex Research 2023: independent reanalysis of the bremelanotide trials doi.org
Reference information only, not medical advice. Drawn from the Bremelanotide article, fact-checked against the cited sources. No dosing anywhere on this site.