MyPeptideMatch
Key Takeaways
- PT-141, also known as bremelanotide, is FDA-approved for hypoactive sexual desire disorder (HSDD) in premenopausal women.
- It is listed on the FDA's compounding bulk drug substances list as Category 1, allowing compounding under specific conditions.
- PT-141 is available by prescription in the United States but not over-the-counter.
- In Canada, PT-141 is not approved for any therapeutic use and is only available for research purposes.
Current FDA Status
PT-141, marketed as bremelanotide, received FDA approval in June 2019 for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women (FDA, NDA 210557). This approval makes PT-141 a legally prescribable medication within the United States for this specific indication. The peptide works as a melanocortin receptor agonist, specifically targeting the MC4 receptor to increase sexual desire.
The FDA includes PT-141 in its Category 1 list for compounding bulk drug substances, which means it can be compounded under certain conditions by pharmacies (Federal Register, Vol. 85, No. 22).
Compounding Status
PT-141's inclusion in Category 1 allows 503A and 503B pharmacies to compound the peptide, provided they comply with FDA regulations. These regulations require that the compounding be based on a valid prescription for an identified individual patient, and the compounding process must adhere to strict quality standards to ensure patient safety.
Enforcement Actions
To date, there have been no significant DOJ prosecutions or FDA warning letters specifically targeting the legal sale or compounding of PT-141 when used according to its approved indication. However, misuse or off-label promotion can attract regulatory scrutiny, as seen in broader enforcement actions against unauthorized peptide sales.
Prescription vs. Over-the-Counter vs. Research Use
PT-141 is available by prescription only. It cannot be sold over-the-counter in the United States. The peptide is also available for research use, meaning it can be acquired by institutions or individuals conducting scientific studies, but not for human consumption without a prescription. "Research use only" indicates that the peptide is not intended for therapeutic use outside of a controlled research setting.
