Key Takeaway: Daré Bioscience's clinical study on its 3.6% topical sildenafil cream showed positive results, demonstrating good tolerance among postmenopausal women with minimal systemic exposure. The company is actively working to advance this formulation through the FDA's 505(b)(2) regulatory pathway, indicating progress in its development.
Market Sentiment Analysis
POSITIVE FACTORS
Topical sildenafil cream was well tolerated in the study.
Minimal systemic exposure was observed across all doses.
The company is advancing toward FDA's 505(b)(2) pathway.
BiopharmaWatch Analysis
From our catalyst data and publicly available data · not financial advice
Cash runway
~5 mo
High dilution risk
Lead asset
Lopinavir/ ritonavir
Phase 2 · Human Papilloma Virus (HPV)
Full Press Release Details
Daré’s proprietary formulation of topical sildenafil cream, 3.6% was well tolerated across all evaluated doses in the clinical study, with minimal systemic exposure Company continues activities necessary to advance its Sildenafil Cream toward the FDA’s 505(b)(2) regulatory pathway* while in
Frequently Asked Questions
What is the formulation of Daré's sildenafil cream?
Daré's sildenafil cream is a proprietary formulation with a concentration of 3.6%.
How was the sildenafil cream tolerated in the study?
The cream was well tolerated across all evaluated doses with minimal systemic exposure.
What regulatory pathway is Daré pursuing for the cream?
Daré is advancing its sildenafil cream through the FDA's 505(b)(2) regulatory pathway.