PT-141 — bremelanotide — has trial-grade safety data from the RECONNECT Phase 3 program in premenopausal women with hypoactive sexual desire disorder (HSDD). The long-term safety extension (PMID 31599847) extended observations to 52 weeks. The adverse-event profile is well-characterized for the FDA-approved 1.75 mg subcutaneous as-needed indication; research-peptide and compounded use for other indications (male ED, libido enhancement) is informed by the same pharmacology but is not covered by formal trials.
Research-context information only. PT-141 (bremelanotide) is the active ingredient in FDA-approved products for premenopausal hypoactive sexual desire disorder; research-peptide and compounded forms for off-label use are not FDA-approved. Protocols, doses, and reactions reported below come from clinical trials and self-reported community sources. This article reports what has been documented, not what should be done. Consult a licensed physician for personal medical decisions.
This article walks through the Phase 3 trial-reported events, FDA-label-listed precautions, and community self-reports for off-label use.
Trial-Reported Adverse Events
From the RECONNECT Phase 3 long-term safety extension (PMID 31599847) and the pivotal trials (PMID 31599840):
| Event | Frequency in active arm | Source |
|---|---|---|
| Nausea | ~40% | PMID 31599847 |
| Flushing | ~21% | PMID 31599847 |
| Headache | ~12% | PMID 31599847 |
| Injection-site reactions | ~13% | RECONNECT trial data |
| Vomiting alongside nausea | ~3.5% | PMID 31599840 |
| Transient BP elevation | Documented | FDA labeling |
| Focal hyperpigmentation | Sparse | RECONNECT trial data |
| Discontinuation due to AEs | ~11-19% in the 52-week extension (most often nausea) | PMID 31599847 |
The 40% nausea rate is the dominant trial finding. Most cases were mild-to-moderate; the discontinuation rate driven by nausea was approximately 8% across the program.
