PT-141 (Bremelanotide) Compounding Pharmacy: How to Choose a Peptide Compounder

At a glance

• Approved product / Vyleesi 1.75 mg subcutaneous autoinjector, prescription only [1][2]
• Approved use / Premenopausal women with acquired, generalized HSDD [1]
• Compounded PT-141 / Not Vyleesi; not an FDA-approved drug [3]
• FDA review / Compounded drugs are not reviewed for safety, effectiveness or quality before marketing [3]
• FDA lists / Bremelanotide is not on the significant-risk page, the bulk-substance lists, or the six-peptide HHS draft policy [6][7][8]
• Where to check / FDA compounding actions page and FDA registered outsourcing facility list [4][5]

What is FDA-approved as PT-141?

Bremelanotide is approved as Vyleesi (NDA 210557, original approval June 21, 2019; current holder Cosette Pharmaceuticals, originally AMAG) [1][2]. Vyleesi is a prescription 1.75 mg injection supplied in a prefilled autoinjector for premenopausal women with acquired, generalized HSDD [1]. The label says it is not indicated for postmenopausal women or for men, and not indicated to enhance sexual performance [1].

Is compounded PT-141 the same as Vyleesi?

No. PT-141 sold as a compounded or research-use peptide is not Vyleesi and is not an FDA-approved drug, and compounded drugs are not reviewed by FDA for safety, effectiveness or quality before marketing [3]. The approval, dose and label data on this page belong to Vyleesi, not to a compounded product [1][3].

How do you check a compounding facility?

Two FDA pages let you look up a facility by name.

FDA's compounding actions page lists individual compounding facilities alongside the actions taken, including Form 483 inspection observations, warning letters, untitled letters and state referral letters [4].

If a facility says it is a registered outsourcing facility, FDA's registry lists each one with its initial and most recent registration dates, its last inspection date, whether a Form 483 was issued, and whether a recall was conducted; the table was updated as of 10/23/2026 [5]. Registration or inspection is not an approval of any particular compounded drug [3].

What do FDA's compounding documents say about bremelanotide?

Bremelanotide does not appear on FDA's page of bulk substances that may present significant safety risks when compounded, content dated 04/22/2026 [6]. It does not appear in any category on FDA's bulk-substance lists [7], and it is not one of the six peptides in HHS's October 2026 draft enforcement-discretion policy [8]. Being absent from those lists does not establish safety or effectiveness.

What does the Vyleesi label say about dose and effects?

The Vyleesi label recommends 1.75 mg injected under the skin of the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity [1]. The label recommends no more than one dose in 24 hours and says more than 8 doses per month is not recommended [1].

Each dose transiently raises blood pressure and lowers heart rate. Maximal increases in clinical studies were 6 mmHg systolic and 3 mmHg diastolic, peaking 2 to 4 hours after the dose, with heart rate down up to 5 beats per minute; in an ambulatory study of 127 premenopausal women dosed daily for 8 days, mean daytime increases were 1.9 mmHg systolic and 1.7 mmHg diastolic [1]. Vyleesi is contraindicated in uncontrolled hypertension or known cardiovascular disease [1]. The label also reports nausea in 40.0% of Vyleesi patients versus 1.3% on placebo, and focal hyperpigmentation in 1% of patients given up to 8 doses per month versus none on placebo [1]. These figures come from Vyleesi trials and do not describe a compounded product [1][3].

Frequently asked questions

›Is compounded PT-141 the same as Vyleesi?

No. Vyleesi is the FDA-approved bremelanotide product [1][2]. PT-141 sold as a compounded or research-use peptide is not Vyleesi and is not an FDA-approved drug, and compounded drugs are not reviewed by FDA for safety, effectiveness or quality before marketing [3].

›Where can I check a compounding pharmacy?

FDA lists compounding facilities with Form 483s, warning letters and other actions on its compounding actions page [4]. FDA also publishes a registry of registered outsourcing facilities showing registration dates, last inspection, whether a Form 483 was issued and whether a recall was conducted, updated as of 10/23/2026 [5].

›Is bremelanotide on FDA compounding risk lists?

No. Bremelanotide does not appear on the FDA page of bulk substances that may present significant safety risks, in any category on the FDA bulk-substance lists, or among the six peptides in the HHS October 2026 draft enforcement-discretion policy [6][7][8].

›What dose does the Vyleesi label recommend?

Vyleesi is 1.75 mg subcutaneously in the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity. The label recommends no more than one dose in 24 hours and says more than 8 doses per month is not recommended [1].

References

1. 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
2. U.S. Food and Drug Administration. FDA approval letter, Vyleesi NDA 210557, 2019
3. Federal Register public inspection document 2026-22192. Federal Register public inspection document 2026-22192
4. Compounding: Inspections, Recalls, and other Actions | FDA. Compounding: Inspections, Recalls, and other Actions | FDA
5. Registered Outsourcing Facilities | FDA. Registered Outsourcing Facilities | FDA
6. 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
7. U.S. Food and Drug Administration. FDA bulk drug substances lists for compounding
8. U.S. Department of Health and Human Services. HHS 503A peptide enforcement discretion policy, Appendix B