© 2023 by Daré Bioscience | Daré Bioscience® is a registered trademark of Daré Bioscience, Inc.
OurPipeline*
Daring to be Different™ and Advancing Products Women Want
Daring to be Different™ and Advancing Products Women Want
We are committed to identifying, licensing or acquiring and developing candidates that expand options, improve outcomes and facilitate convenience for women. In addition to our lead products in development, our accelerator boasts a broad portfolio of diverse product candidates with first-in-category potential for women requiring or desiring new therapies in contraception, vaginal health, sexual health and fertility.
Pre-clinical
Phase 1
Phase 2
Phase 3
Approved
XACIATO™
Bacterial Vaginosis
Collaborator: Organon
XACIATO™ (clindamycin phosphate) vaginal gel, 2%
Ovaprene®
Hormone-Free, Monthly Contraception
Collaborators: Bayer & NIH
A novel, hormone-free monthly intravaginal contraceptive candidate (Self-administered intravaginal drug/device)
Partner: 
Investigational hormone-free monthly intravaginal contraceptive designed to be an easy-to-use monthly option with effectiveness approaching hormonal methods; commercial partnership agreement with Bayer. There are currently no FDA-approved monthly hormone-free contraceptives. Learn More.
Sildenafil Cream, 3.6%^
Female Sexual Arousal Disorder
Potential first-in-category for treatment of Female Sexual Arousal Disorder (Topical cream, same active ingredient as Viagra®)
Investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical administration to treat FSAD. FSAD is a physiological condition characterized by the inability to attain or maintain sufficient genital arousal during sexual activity, for which there are no FDA-approved treatments. Of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction in men. Learn More.
DARE-HRT1^‡
Hormone Therapy
First-in-category Sustained-Release Hormone Therapy
First-in-category combination hormone delivery for treatment of vasomotor and vaginal symptoms of menopause. Intravaginal ring (IVR) designed to release bio-identical estradiol and bio-identical progesterone over 28 days. Learn More.
DARE-VVA1^‡
Vulvar and Vaginal Atrophy
First-in-category Treatment for VVA for ER/PR+ Breast Cancer Patients
First-in-category hormone-free vaginal treatment for vulvar and vaginal atrophy (VVA) in a hormone-receptor positive, breast cancer patient population. Proprietary formulation of tamoxifen for vaginal administration. Learn More.
DARE-PDM1^
Primary Dysmenorrhea
Potential First-in-Category Treatment for Primary Dysmenorrhea
Novel delivery of the active pharmaceutical ingredient diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), using Daré’s proprietary hydrogel technology targeted at treating primary dysmenorrhea.
DARE-FRT1/PTB1^
Pregnancy Maintenance
First-in-category Sustained Release Progesterone for Pregnancy Maintenance
First-in-category progesterone delivery for pregnancy maintenance including the prevention of preterm birth and for luteal phase support as part of an IVF regimen. IVR designed to release bio-identical progesterone over 14 days.
ADARE 204/214^
6 & 12 Month Injectable Contraception
First-in-category 6 & 12 Month Injectable Contraception
Novel 6 & 12-month injectable formulations of etonogestrel being developed as a longer-acting, reversible method of contraception with a more predictable return to fertility.
DARE-LARC1^
Long-Acting, Reversible Personal Contraceptive System
First-in-category, User-Controlled, Long-Acting, Reversible Contraceptive (UC-LARC)
Levonorgestrel-releasing long-acting contraceptive implant that a woman can turn on and off herself, according to her own needs. Learn More.
DARE-GML
Novel Antimicrobial Glycerol Monolaurate
First-in-category Multi-Target Antimicrobial
Glycerol monolaurate has the potential to deliver broad antimicrobial activity to treat a variety of bacterial, fungal, and viral vaginal infections.
DARE-LBT
Hydrogel Formulation for Delivery of Live Biotherapeutics to Support Vaginal Health
Novel hydrogel formulation for the delivery of live biotherapeutics to support vaginal health
Reconstitutable vaginal thermosetting gel formulation to ultimately serve as a delivery vehicle that allows administration of live biotherapeutics at the point of care in a wide range of settings to support vaginal health.
DARE-RH1
Male or Female Contraceptive Target
First-in-category Male or Female Contraceptive Target
A potential new rapidly reversible, non-hormonal contraceptive solution with application for women and men.
^505(b)(2) regulatory pathway anticipated. *Ovaprene Post Coital Test (PCT) is a pre-pivotal clinical study.
‡DARE-HRT1 and DARE-VVA1 Phase 1 studies conducted in Australia by Daré subsidiary.
*This timeline reflects management’s estimates in the most recently filed corporate presentation and constitutes a forward-looking statement subject to qualifications described in the Terms of Service, including Section 13.4, Forward-Looking Statements; Disclaimer. Actual development timeline may be substantially longer, and Daré is under no obligation to update or review this estimate. “First-in-category” designation is a forward-looking statement based on management’s current expectations and currently available FDA-approved therapies.
Scientific & Clinical Publications
Publication/Event
Author(s)
Name/Title
Date
Related Daré Candidate or Platform
Publication/Event
Menopause: The Journal of The North American Menopause Society, Vol. 30, No. 4, 2023
Author(s)
Hull, et al.
Date
1/24/2023
Related Daré Candidate or Platform
DARE-HRT1
Publication/Event
13th European Congress on Menopause and Andropause
Author(s)
Hull, et al.
Date
9/8/2021
Related Daré Candidate or Platform
DARE-HRT1
Publication/Event
9th Annual Partnership Opportunities in Drug Delivery Conference
Author(s)
Friend
Date
10/7/2019
Related Daré Candidate or Platform
DARE-HRT1, DARE-FRT1, DARE-PTB1
Publication/Event
2019 Controlled Release Society Annual Meeting & Exposition
Author(s)
Kiang and Friend
Date
7/22/2019
Related Daré Candidate or Platform
DARE-HRT1
Publication/Event
2019 Controlled Release Society Annual Meeting & Exposition
Author(s)
Kiang and Friend
Date
7/22/2019
Related Daré Candidate or Platform
DARE-HRT1
Publication/Event
Journal of Pharmaceutical Sciences 108 (2019) 2677-2684
Author(s)
Weiss, et al.
Date
4/5/2019
Related Daré Candidate or Platform
DARE-HRT1
Publication/Event
Drug Delivery and Translational Research (2019) 9:1008–1016
Author(s)
Weiss, et al.
Date
5/7/2019
Related Daré Candidate or Platform
DARE-PTB1
Publication/Event
The Journal of Sexual Medicine
Author(s)
Symonds, et al.
Date
1/23/2023
Related Daré Candidate or Platform
Sildenafil Cream, 3.6%
Publication/Event
International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting 2020
Author(s)
Goldstein, et al.
Date
3/9/2020
Related Daré Candidate or Platform
Sildenafil Cream, 3.6%
Publication/Event
International Journal of Pharmaceutics 570 (2019) 118691
Author(s)
Chollet, et al.
Date
9/10/2019
Related Daré Candidate or Platform
DARE-VVA1
Publication/Event
2021 Controlled Release Society Virtual Annual Meeting
Author(s)
Mauck, et al.
Date
7/27/2021
Related Daré Candidate or Platform
XACIATO™ (clindamycin phosphate) vaginal gel, 2%
Publication/Event
AIDS RESEARCH AND HUMAN RETROVIRUSES, Volume 36
Author(s)
Guthrie, et al.
Date
11/12/2020
Related Daré Candidate or Platform
XACIATO™ (clindamycin phosphate) vaginal gel, 2%; vaginal hydrogel
Publication/Event
2019 Annual Meeting of Infectious Diseases Society for Obstetrics and Gynecology
Author(s)
Dupre, et al.
Date
8/8/2019
Related Daré Candidate or Platform
XACIATO™ (clindamycin phosphate) vaginal gel, 2%
This page is intended to provide scientific and clinical research information solely for informational purposes. The publications and presentations listed here do not represent all of the information available on the topics addressed or related to our development programs. Our first product was approved by the U.S. Food and Drug Administration (FDA) in December 2021. Learn more here. None of our investigational products or potential product candidates, including Ovaprene®, Sildenafil Cream 3.6%, DARE-HRT1, DARE-VVA1, DARE-FRT1, DARE-PTB1, DARE-LARC1, ADARE 204/214 and DARE-RH1, has been approved by the FDA or any other regulatory agency for use outside of a clinical trial.