FDA Status
FDA-Approved (2019)
Vyleesi — for HSDD in premenopausal women. SC injection only; intranasal halted 2007.
Claimed Benefits
- Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women
- Erectile dysfunction (off-label; works where Viagra fails)
- Central sexual arousal (acts on brain, not genitals)
- Female Sexual Arousal Disorder (FSAD)
Clinical Evidence
4
Human Trials
Phase III
FDA-Approved
Phase 3 RECONNECT trials (N=1,267) showed significantly increased sexual desire and reduced distress vs. placebo. Led directly to FDA approval in 2019.
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Mechanism, dosing, vendor pricing, and full research citations