PT-141 (Bremelanotide) Compounding Pharmacy: FDA and State Board Enforcement History
At a glance
- Approved product / Vyleesi (bremelanotide) 1.75 mg autoinjector, NDA 210557, approved June 21, 2019 [4][5]
- Approved use / Premenopausal women with acquired, generalized HSDD [4]
- Compounded PT-141 / Not Vyleesi; not an FDA-approved drug [4][6]
- FDA safety-risk bulk list / Bremelanotide not listed; content dated 04/22/2026 [1]
- HHS October 2026 peptide policy / Six peptides named; bremelanotide not among them [3]
- Warning letters and state board actions / Not covered on this page
Does FDA list bremelanotide as a compounding safety risk?
No. FDA's page of bulk drug substances that may present significant safety risks in compounding, with content dated 04/22/2026, does not include bremelanotide [1], and bremelanotide appears in no category on FDA's bulk-substance lists [2]. Peptides that FDA does list there include GHRP-2 and GHRP-6, flagged for immunogenicity risk from aggregation and peptide-related impurities [1].
HHS's October 2026 draft enforcement-discretion policy for compounded peptides names six peptides; bremelanotide is not one of them [3].
Is compounded PT-141 the product FDA approved?
No. Vyleesi is the FDA-approved bremelanotide product, a 1.75 mg subcutaneous autoinjector approved on June 21, 2019 under NDA 210557 [4][5]. PT-141 sold by compounding pharmacies or research-peptide vendors is not Vyleesi and is not an FDA-approved drug [4][6].
FDA states that compounded drugs are not FDA-approved and are not reviewed for safety, effectiveness or quality before they reach patients [6]. The approved use is narrow: premenopausal women with acquired, generalized HSDD. The label states Vyleesi is not indicated in postmenopausal women, in men, or to enhance sexual performance [4].
What is established about PT-141 enforcement?
Bremelanotide is not named on FDA's safety-risk list or in HHS's October 2026 peptide policy [1][3]. This page does not cover FDA warning letters, inspection findings or state pharmacy board actions involving PT-141 or bremelanotide, so it makes no claim about whether any exist.
What does the Vyleesi label say to watch for?
The label says each dose transiently raises blood pressure and lowers heart rate. In clinical studies the maximal increases were 6 mmHg systolic and 3 mmHg diastolic, peaking 2 to 4 hours after dosing, with heart rate down by up to 5 beats per minute and values usually back to baseline within 12 hours [4]. These are maximal figures, not averages. Vyleesi is contraindicated in uncontrolled hypertension or known cardiovascular disease [4].
In the phase 3 trials, nausea was reported by 40% of treated patients versus 1.3% on placebo. Thirteen percent received an anti-nausea medicine and 8% stopped the trials because of it [4].
Frequently asked questions
Is compounded PT-141 an FDA-approved drug?
Is bremelanotide on FDA's bulk-substance safety-risk list?
Does Vyleesi carry a boxed warning or REMS?
References
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
- U.S. Food and Drug Administration. U.S. Food and Drug Administration
- Official web page. Official web page
- U.S. National Library of Medicine, DailyMed. Vyleesi (bremelanotide) injection, 1.75 mg subcutaneous autoinjector prescribing information. Vyleesi (bremelanotide) injection, 1.75 mg subcutaneous autoinjector label
- U.S. Food and Drug Administration. U.S. Food and Drug Administration
- Human Drug Compounding Laws | FDA. Human Drug Compounding Laws | FDA