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Current regulator label
PT-141 (bremelanotide) is the active ingredient in Vyleesi, FDA-approved for acquired, generalized HSDD in premenopausal women; this page explains what it is, its approval status, and its key safety cautions.
PT-141 (bremelanotide) dosage calculator →
Arithmetic only, not medical advice.
PT-141 (bremelanotide): reference record
| Regulatory status | FDA-approved as Vyleesi for a narrow labeled indication |
|---|---|
| Route | Subcutaneous |
| Dosing frequency | As needed |
| Published range | 1.75 mg |
| Evidence basis | Current regulator label |
| Common vial sizes | 10 |
Sources
- FDA prescribing information (PT-141 (bremelanotide)) - accessdata.fda.govBasis for the regulatory status, route, frequency and published range in the table above. Source last checked 2026-06-24
What is PT-141 (bremelanotide)?
PT-141, also written bremelanotide, is a melanocortin receptor agonist and the active ingredient in Vyleesi. It is also commonly written PT 141, and it acts centrally rather than on the vascular system.
Is PT-141 (bremelanotide) FDA-approved?
Partly, and the distinction matters. Bremelanotide is FDA-approved as Vyleesi for one narrow labeled indication: acquired, generalized hypoactive sexual desire disorder in premenopausal women. Research-grade PT-141 powder sold under the same name is not the approved product.
How is PT-141 (bremelanotide) given?
The approved product is given subcutaneously on an as-needed basis, using a single-use autoinjector supplied at a labeled concentration rather than a vial you reconstitute.
What are the known safety concerns with PT-141 (bremelanotide)?
It is contraindicated in uncontrolled hypertension or known cardiovascular disease. Because the approved presentation is an autoinjector, any reconstituted powder falls outside the labeled product entirely.
1.75 mg at least 45 min before anticipated sexual activity; max 1 dose/24 h and not more than 8/month
Commercial Vyleesi is a 1.75 mg/0.3 mL autoinjector; no reconstitution required.
Contraindicated in uncontrolled hypertension or known cardiovascular disease.
Supply-chain quality · Finnrick
Avg quality score
7
/10
Purity range
96.09
–
99.95
%
Qty divergence
±
51
%
Vendors · samples
27
·
97
Common vial sizes
10
mg
Test window
Mar 2025 - Apr 2026
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