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, menopause, 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 self-administered intravaginal contraceptive drug/device 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.
Notable Publications†
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Publication / Event
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Author(s)
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Title
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Date
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Contraception, Vol. 135, July 2024
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Mauck, et al.
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3/27/2024
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Contraception, Vol. 133, May 2024
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Davis, et al.
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2/9/2024
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Contraception, Vol. 132, April 2024
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Mauck, et al.
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1/15/2024
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Sildenafil Cream, 3.6%^
Female Sexual Arousal Disorder
Potential first-in-category for treatment of Female Sexual Arousal Disorder (FSAD)
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. Of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction in men. There are currently no FDA-approved treatments for FSAD. Learn More.
Notable Publications†
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Publication / Event
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Author(s)
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Title
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Date
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Sexual Medicine, Volume 12, Issue 5, October 2024
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Johnson, et al.
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11/19/2024
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Obstetrics & Gynecology. 144(2):p 144-152, August 2024.
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Johnson, et al.
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6/18/2024
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| The Journal of Sexual Medicine. 2024; 21(9):793-799. | Thurman, et al. | Safety of topical sildenafil cream, 3.6% in a randomized, placebo-controlled trial for the treatment of female sexual arousal disorder | 7/31/2024 |
| The Journal of Sexual Medicine. 2024; 21(9): 787-792. | Johnson, et al. | Comparisons and correlations of 1-month recall vs 24-hour recall in patient-reported outcomes of an exploratory, phase 2b, randomized, double-blind, placebo-controlled clinical trial of sildenafil cream, 3.6% for the treatment of female sexual arousal disorder | 7/26/2024 |
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The Journal of Sexual Medicine. 2023 Feb 27; 20(3):277-286
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Symonds, et al.
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2/27/2023
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The Journal of Sexual Medicine. 2020 Jan; 17(Suppl 1):S69.
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Goldstein, et al.
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1/1/2020
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DARE-HRT1^‡
Menopausal Hormone Therapy
Potential first-in-category vaginal combination hormone delivery for treatment of vasomotor and vaginal symptoms due to menopause
Self-administered intravaginal ring (IVR) designed to release bio-identical estradiol and bio-identical progesterone over 28 days. There are currently no FDA-approved options with both hormones in one monthly IVR. Potential to be the first convenient monthly format product with both hormones. Learn More.
Notable Publications†
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Publication / Event
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Author(s)
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Title
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Date
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Menopause: The Journal of The North American Menopause Society, Vol. 30, No. 9, 2023
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Thurman, et al.
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8/9/2023
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Menopause: The Journal of The North American Menopause Society, Vol. 30, No. 8, p 817-823, August 2023
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Thurman, et al.
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6/21/2023
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Climacteric (2023)
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Hull, et al.
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4/13/2023
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Menopause: The Journal of The North American Menopause Society, Vol. 30, No. 4, p 427-436, April 2023
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Hull, et al.
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1/24/2023
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Journal of Pharmaceutical Sciences 108 (2019) 2677-2684
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Weiss, et al.
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1/24/2023
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DARE-VVA1^‡
Vulvar and Vaginal Atrophy (VVA)
Potential first-in-category hormone-free intravaginal treatment for VVA
Proprietary formulation of tamoxifen for vaginal administration. There are currently no FDA-approved vaginal hormone-free treatments for VVA. Learn More.
Notable Publications†
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Publication / Event
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Author(s)
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Title
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Date
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Climacteric (2023)
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Thurman, et al.
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6/08/2023
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International Journal of Pharmaceutics 570 (2019) 118691
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Chollet, et al.
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9/10/2019
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DARE-HPV^
HPV-Related Cervical Disease
Potential first-in-category non-surgical treatment for HPV-related cervical disease
Proprietary formulation of lopinavir and ritonavir for vaginal administration. There are currently no FDA-approved non-surgical pharmaceutical treatments for HPV-related cervical disease. Learn More.
Notable Publications†
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Publication / Event
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Author(s)
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Title
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Date
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PLoS ONE (2016) 11(1):e0147917
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Hampson, et al.
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6/08/2023
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DARE-PDM1^‡
Primary Dysmenorrhea
Potential First-in-Category Treatment for Primary Dysmenorrhea
Proprietary hydrogel formulation of diclofenac for vaginal administration. Alternative to oral nonsteroidal anti-inflammatory drugs and hormonal contraceptives, which often can produce undesirable side effects. There are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea. Learn more…
Casea S
Biodegradable Long-Acting Contraception
Collaborator: Theramex
Potential First-in-Category Biodegradable Long-Acting Contraceptive Implant
Casea S is designed to control release of a well-characterized contraceptive for a set period of time (18-24 months) before dissolving. It is designed to provide women with a long-acting, minimally-invasive contraceptive method that will not require surgical removal by a healthcare provider, which would improve convenience and could eliminate one of the barriers to use associated with existing implanted contraceptives.
DARE 204/214^
6 & 12 Month Injectable Contraception
Potential 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. There are currently no FDA-approved injectible contraceptives indicated for 6 & 12 months of protection.
DARE-FRT1/PTB1^
Pregnancy Maintenance
First-in-category Sustained Release Progesterone for Pregnancy Maintenance
Progesterone delivery for pregnancy maintenance including the prevention of preterm birth (DARE-PTB1) and for luteal phase support as part of an IVF regimen (DARE-FRT1). IVR designed to release bio-identical progesterone for up to 14 days as an alternative to daily IM injections or vaginal gel. There are currently no FDA-approved products marketed in the U.S. that do not require daily dosing of progesterone.
Notable Publications†
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Publication / Event
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Author(s)
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Title
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Date
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Drug Delivery and Translational Research (2019) 9:1008–1016
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Weiss, et al.
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5/7/2019
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DARE-LARC1^
Long-Acting, Reversible Personal Contraceptive System
Potental first-in-category, user controlled, long-acting, Reversible contraceptive
Levonorgestrel-releasing, long-acting contraceptive implant that a woman can turn on and off herself, according to her own needs. Grant of up to $48.95 M to advance technology through non-clinical proof of principle to enable IND submission. There are currently no FDA-approved contraceptive implants available that allow one to remotely pause and resume dosing. Learn More.
^505(b)(2) regulatory pathway anticipated.
‡DARE-HRT1, DARE-VVA1, and DARE-PDM1 Phase 1 studies conducted in Australia by Daré subsidiary.
* As of 4/17/2024. This section includes forward-looking statements subject to qualifications described in the Terms of Service, including Section 13.4, Forward-Looking Statements; Disclaimer, and reflects management’s estimates and expectations as of the foregoing date. Product development progress and milestones and regulatory approval may take substantially longer to achieve than anticipated, or may never be achieved. As used herein, a “first-in-category” designation is a forward-looking statement based on management’s current expectations and currently available FDA-approved therapies. Except as may be required by law, Daré is under no obligation to update the information provided in this section.
† The ”Notable Publications” sections of this page are intended to make scientific and clinical research information accessible solely for informational purposes. The listed publications and presentations 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 those identified on this page, has been approved by the FDA or any other regulatory agency for use outside of a clinical trial.