Bremelanotide research: studies, doses and safety

• Around the first dose: Nausea is common with Vyleesi, usually starting within about an hour and lasting about two hours.
• Within 12 hours after a dose: Vyleesi can briefly raise blood pressure and slow the pulse, with readings usually returning to baseline within 12 hours.
• Later doses: Nausea is most common after the first Vyleesi dose and is less common with later doses.
• Week 8: The Vyleesi label calls for stopping treatment if symptoms have not improved after eight weeks.

Vyleesi is used as needed for eligible premenopausal women with low sexual desire, at most once per 24 hours; more than eight monthly doses is not recommended.

A 2022 safety review counted 43 completed studies and 3,500 participants, a minimum, not a complete 2026 count.

Key studies

• Dose finding: 0.75–1.75 mg: The 1.75 mg dose advanced to phase 3. (source)
• RECONNECT 301: 1.75 mg: Desire and distress improved modestly; satisfying event counts did not. (source)
• RECONNECT 302: 1.75 mg: Desire and distress improved modestly; satisfying event counts did not. (source)
• RECONNECT: one-year extension: The extension adds longer exposure but has strong survivor bias. (source)
• Early male injection studies: Single doses up to 10 mg were studied; that is not a safe repeated-dose ceiling. (source)
• Early male nasal studies: Responses were significant at doses above 7 mg; first erection began at about 30 minutes. (source)