---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-050117"
form_type: "8-K"
ticker: "DARE"
cik: "0001401914"
company_name: "Dare Bioscience, Inc."
filed_at: "2024-12-16T23:59:59+00:00"
generated_at: "2026-05-29T02:50:39.567308+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Daré announces Phase 3 plans for Sildenafil Cream for FSAD; protocol submission in Q1 2025

## Summary
- Will submit Phase 3 protocol and statistical plan to FDA in Q1 2025; target mid-2025 to start the study.
- A second confirmatory Phase 3 study will be required for NDA submission.
- Phase 3 co-primary endpoints are arousal sensations and associated distress, same as Phase 2b RESPOND study.
- Sildenafil Cream has potential to be first FDA-approved pharmacological treatment for FSAD (no current approved options).
- Market research estimates ~10M U.S. women distressed by FSAD symptoms actively seeking solutions.

## SEC filing metadata
- accession: 0001493152-24-050117
- form_type: 8-K
- ticker: DARE
- cik: 0001401914
- company_name: Dare Bioscience, Inc.
- filed_at: 2024-12-16T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1401914/000149315224050117/0001493152-24-050117-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1401914/000149315224050117/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-050117
- JSON: https://secwatch.observer/filing/0001493152-24-050117.json
- Plain text: https://secwatch.observer/filing/0001493152-24-050117.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.