Dare Bioscience
Daré Bioscience's mission is to challenge the status quo and make women's health a priority by bringing innovative, evidence-based treatment solutions to market in areas such as contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health, and menopause. The company aims to address decades of unmet needs in women's health by leveraging products with existing clinical proof of concept or safety data, and focuses on rapid, responsible commercialization to meet increasing demand for evidence-based solutions.
Industries
Nr. of Employees
small (1-50)
Dare Bioscience
Cambridge, Massachusetts, United States, North America
Products
Topical sildenafil cream, 3.6% (development for female sexual arousal disorder)
Topical sildenafil formulation developed for treatment of female sexual arousal disorder; progressed through clinical development and regulatory interaction.
Clindamycin phosphate vaginal gel, 2% (bacterial vaginosis treatment)
Topical vaginal gel formulation of clindamycin phosphate developed for treatment of bacterial vaginosis and advanced in clinical programs.
Intravaginal contraceptive device (Ovaprene study product)
Intravaginal contraceptive device evaluated in clinical studies as a non‑hormonal contraceptive option.
Hormone replacement therapy product candidate (DARE-HRT1)
Product candidate for menopausal hormone therapy advanced through clinical evaluation.
Pelvic pain / related product candidate (DARE-PDM1)
Product candidate evaluated with pharmacokinetic data and clinical testing in development for pelvic pain management.
User-controlled long-acting reversible contraceptive (LARC) development program
Development program for a user-controlled, long-acting reversible contraceptive device and associated delivery platform acquired as part of strategic expansion.
Topical sildenafil cream, 3.6% (development for female sexual arousal disorder)
Topical sildenafil formulation developed for treatment of female sexual arousal disorder; progressed through clinical development and regulatory interaction.
Clindamycin phosphate vaginal gel, 2% (bacterial vaginosis treatment)
Topical vaginal gel formulation of clindamycin phosphate developed for treatment of bacterial vaginosis and advanced in clinical programs.
Intravaginal contraceptive device (Ovaprene study product)
Intravaginal contraceptive device evaluated in clinical studies as a non‑hormonal contraceptive option.
Hormone replacement therapy product candidate (DARE-HRT1)
Product candidate for menopausal hormone therapy advanced through clinical evaluation.
Pelvic pain / related product candidate (DARE-PDM1)
Product candidate evaluated with pharmacokinetic data and clinical testing in development for pelvic pain management.
User-controlled long-acting reversible contraceptive (LARC) development program
Development program for a user-controlled, long-acting reversible contraceptive device and associated delivery platform acquired as part of strategic expansion.
Services
Clinical development and trial operations
End-to-end clinical study services from protocol development to study execution and data interpretation.
Product development and formulation
Formulation development and preclinical-to-clinical translation for topical, injectable and implantable dosage forms and combination products.
Manufacturing and supply chain management
Planning and management of manufacturing scale-up, commercial supply and specialty product logistics.
Regulatory strategy and agency engagement
Regulatory planning, FDA engagement and preparation for regulatory meetings and submissions.
Alliance management and business development
Licensing, acquisitions, strategic partnerships and alliance governance to advance development programs.
Expanded access and compassionate use policy implementation
Development of company policy for expanded access consistent with regulatory guidance and program constraints.
Clinical development and trial operations
End-to-end clinical study services from protocol development to study execution and data interpretation.
Product development and formulation
Formulation development and preclinical-to-clinical translation for topical, injectable and implantable dosage forms and combination products.
Manufacturing and supply chain management
Planning and management of manufacturing scale-up, commercial supply and specialty product logistics.
Regulatory strategy and agency engagement
Regulatory planning, FDA engagement and preparation for regulatory meetings and submissions.
Alliance management and business development
Licensing, acquisitions, strategic partnerships and alliance governance to advance development programs.
Expanded access and compassionate use policy implementation
Development of company policy for expanded access consistent with regulatory guidance and program constraints.
Expertise Areas
- Clinical trial management
- Women’s health therapeutics (contraception, sexual and vaginal health, fertility, menopause)
- Drug delivery system development
- Combination product (drug-device) development
Key Technologies
- Topical formulation development
- Vaginal drug delivery systems (gels, rings)
- Long-acting injectable formulations
- Implantable drug delivery devices