▶ PT-141 · SUBTOPIC · SAFETY PROFILE
PT-141 Safety Profile
For Laboratory Research Use Only. This page summarises observed adverse events and regulatory status reported in the peer- reviewed literature. It is not medical advice and does not recommend any human use of PT-141.
OBSERVED ADVERSE EVENTS IN LITERATURE
The following adverse events have been observed in trials or animal studies of PT-141. Severity, frequency, and attribution depend on the source publication.
- Nausea (most common)
- Facial flushing
- Headache
- Transient systolic BP elevation ~6 mmHg
DRUG INTERACTIONS
The following interactions are reported in or theorised from the published mechanism for PT-141.
- Avoid in uncontrolled hypertension or known cardiovascular disease
CONTRAINDICATIONS REPORTED IN LITERATURE
Contraindications recorded for PT-141 in the published record:
- Uncontrolled hypertension
- Known cardiovascular disease
FDA REGULATORY STATUS
FDA-approved as Vyleesi (bremelanotide) for HSDD in premenopausal women (June 2019).
WADA REGULATORY STATUS
Not currently listed on the WADA Prohibited List.
SAFETY Q+A FROM LITERATURE
▶ What is PT-141?
PT-141 (bremelanotide, brand Vyleesi) is a cyclic 7-amino-acid peptide melanocortin 3/4 receptor agonist. FDA-approved June 2019 for hypoactive sexual desire disorder (HSDD) in premenopausal women.
▶ Is PT-141 FDA-approved?
Yes. FDA-approved as Vyleesi for HSDD in premenopausal women, June 2019. Distributed by Palatin Technologies/Cosette.
▶ Side effects?
Most common: transient nausea (~40% incidence at the approved dose). Less common: facial flushing, headache, injection-site reactions, mild transient blood pressure increase.
▶ Who shouldn't use PT-141?
Vyleesi label contraindicates use in uncontrolled hypertension or known cardiovascular disease due to transient BP elevation in trials. Consult a healthcare provider for clinical use.
▶ Is PT-141 banned in sports?
Not currently listed on the WADA Prohibited List.
CITED LITERATURE
The safety statements above are drawn from the following peer-reviewed sources. Refer to the originals for adverse- event tables, attribution, and full context.
- Kingsberg SA, Clayton AH, et al.. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol 2019. PMID 31022173. link
- Clayton AH, et al.. Bremelanotide for female sexual dysfunctions in premenopausal women. Womens Health (Lond) 2016. PMID 27193591. link
RELATED PAGES
▶ LAST UPDATED · 2026-05-19