What it is
PT-141 is the research name for bremelanotide, a synthetic peptide that activates melanocortin receptors in the brain.
What the research says
- Bremelanotide has been studied in randomized trials for one approved use. Those results apply to the approved product, not to compounded PT-141.
Regulatory status
FDA has approved a separate bremelanotide injection product for a specific use in premenopausal women [1]. Compounded PT-141 is not that product, is not FDA approved, and has not been reviewed by FDA for safety, effectiveness or quality. Where prescribed, compounded versions are prepared by state-licensed 503A compounding pharmacies.
Safety and side effects
The approved product's label warns of a transient increase in blood pressure and decrease in heart rate after each dose, usually resolving within 12 hours. It is contraindicated in people with uncontrolled high blood pressure or known cardiovascular disease and is not recommended for people at high risk for cardiovascular disease [1]. The label also warns of focal hyperpigmentation (darkening of the skin, including the face, gums and breasts) and of nausea, reported by 40% of trial patients. Its most common adverse reactions are nausea, flushing, injection site reactions, headache and vomiting [1]. A licensed healthcare provider should review your history, medications and blood pressure first.
Is it right for you?
Only a licensed healthcare provider can decide whether any treatment is appropriate for you.
Frequently asked questions
Is compounded PT-141 approved by FDA?
No. Compounded PT-141 is not FDA approved and has not been reviewed by FDA for safety, effectiveness or quality. FDA has approved a separate bremelanotide product for one specific use [1].
Do I need a prescription for PT-141?
Yes. Prescription only, requires evaluation by a licensed provider. A provider decides whether it is appropriate for you.
Sources
- FDA prescribing information, VYLEESI (bremelanotide injection), revised 10/2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf
PT-141 content on this page is for education. Compounded medications are not FDA approved. Prescription only, requires evaluation by a licensed provider. Educational content only, not medical advice.