Background
Female Sexual Interest/Arousal Disorder (FSIAD) is a prevalent but under-treated condition, with limited therapeutic options available. No currently approved medication effectively improves sexual arousal in premenopausal women. BZ371A is a topical, non-hormonal peptide-based gel designed to act locally in the genital area to enhance sexual arousal and associated functions.
Methods
This Phase II randomized, double-blind, placebo-controlled, crossover study evaluated the efficacy and safety of BZ371A in women aged 21–60 years diagnosed with FSIAD. Participants included both pre- and postmenopausal women, with and without concurrent hormone therapy. Subjects applied BZ371A or placebo topically once daily for 14 days, with a washout period before crossover. Doses evaluated were 0.5 mL, 1.0 mL, and 1.5 mL.
The primary endpoint was the proportion of satisfactory sexual arousal responses, assessed using the Female Sexual Encounter Profile (FSEP Q3/Q7). Secondary endpoints included effects on desire, lubrication, orgasm, satisfaction, and pain, assessed through both FSEP and the Female Sexual Function Index (FSFI).
Results
A total of 30 women were randomized, with 48 paired treatment periods analyzed for efficacy (24 BZ371A, 24 placebo).
Primary Outcome
BZ371A significantly improved sexual arousal, with satisfaction reported in 86% of sexual encounters compared to 56% with placebo (p=0.002).
Secondary Outcomes
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Desire: significant improvement vs. baseline (p=0.020)
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Lubrication: 75% vs. 33% at baseline (p<0.001)
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Orgasm: increased from 54% at baseline to 69% with BZ371A
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Overall FSFI domain scores: significant improvements in arousal (p=0.004), lubrication (p=0.003), orgasm (p=0.013), satisfaction (p=0.010), and pain reduction (p=0.010)
Efficacy was observed in both premenopausal and postmenopausal women, regardless of hormone use—highlighting a unique therapeutic potential compared with existing hormonal options.
Safety and Tolerability
BZ371A was safe and well tolerated:
- No severe adverse events related to treatment
- No discontinuations due to adverse events
- Local mild events (e.g., vulvar redness, dysuria, burning sensation) were reported but resolved fully in most cases
- No clinically significant findings on physical, gynecological, ECG, or laboratory examinations
Conclusions
BZ371A demonstrated strong efficacy in improving sexual arousal and related aspects of sexual function in women with FSIAD, meeting its primary and multiple secondary endpoints. Importantly, it is the first therapy to show significant benefit in premenopausal women, a population with no approved treatment options. Its topical, non-hormonal, and locally acting profile supports a favorable safety and tolerability outlook.
Next Steps
These findings support the advancement of BZ371A into Phase III clinical development as a potential first-in-class therapy for FSIAD.