Our Pipeline
Boldly solving what others sideline. Relentlessly closing the gap in care.
From contraception to menopause, pelvic pain to fertility, vaginal health to infectious disease, our evidence-based solutions are built with integrity and delivered at the speed women deserve.
XACIATO™
Bacterial Vaginosis
Collaborator: Organon
Approved
Approved
Ovaprene®
Hormone-Free, Monthly Contraception
Collaborator: NIH
Pivotal Phase 3 Study Underway
Phase 3
A novel, hormone-free monthly intravaginal contraceptive candidate (self-administered drug/device)
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.
Join the hormone-free revolution. We are seeking healthy women to evaluate a non-hormonal birth control product. Compensation provided.
| Publication / Event | Author(s) | Title | Date |
|---|---|---|---|
| Contraception, Vol. 132, April 2024 | Mauck, et al. | Successful postcoital testing of Ovaprene: An investigational nonhormonal monthly vaginal contraceptive | 1/15/24 |
| Contraception, Vol. 135, July 2024 | Mauck, et al. | Safety Testing of Ovaprene: an Investigational Non-Hormonal Monthly Vaginal Contraceptive | 3/27/24 |
| Contraception, Vol. 133, May 2024 | Davis, et al. | A Nine-Month Repeat-Dose Intravaginal Ring (Ovaprene) Irritation Study in Sheep | 2/9/24 |
More Information
A novel, hormone-free monthly intravaginal contraceptive candidate (self-administered drug/device)
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
Join the hormone-free revolution. We are seeking healthy women to evaluate a non-hormonal birth control product. Compensation provided.
Notable Publications¨
| Publication / Event | Author(s) | Title | Date |
|---|---|---|---|
| Contraception, Vol. 132, April 2024 | Mauck, et al. | Successful postcoital testing of Ovaprene: An investigational nonhormonal monthly vaginal contraceptive | 1/15/24 |
| Contraception, Vol. 135, July 2024 | Mauck, et al. | Safety Testing of Ovaprene: an Investigational Non-Hormonal Monthly Vaginal Contraceptive | 3/27/24 |
| Contraception, Vol. 133, May 2024 | Davis, et al. | A Nine-Month Repeat-Dose Intravaginal Ring (Ovaprene) Irritation Study in Sheep | 2/9/24 |
Sildenafil Cream, 3.6%^
Female Sexual Arousal Disorder
Phase 2b Study Completed
Phase 2
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.
More Information
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.
Notable Publications¨
DARE-HRT1^‡
Menopausal Hormone Therapy
IND + Phase 3 Study Preparation
Phase 3
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.
More Information
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.
Notable Publications¨
DARE-VVA1^‡
Genitourinary Syndrome of Menopause (formerly vulvovaginal atrophy)
Phase 2 Study Preparation
Phase 2
Potential first-in-category hormone-free intravaginal treatment for GSM
Investigational hormone-free vaginal insert for sexual pain post-menopause or breast cancer treatment. There are currently no FDA-approved vaginal hormone-free treatments for GSM.
| Publication / Event | Author(s) | Title | Date |
|---|---|---|---|
| Climacteric (2023) | Thurman, et al. | Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy | 6/08/23 |
| International Journal of Pharmaceutics 570 (2019) 118691 | Chollet, et al. | Vaginal tamoxifen for treatment of vulvar and vaginal atrophy: Pharmacokinetics and local tolerance in a rabbit model over 28 days | 9/10/19 |
More Information
Potential first-in-category hormone-free intravaginal treatment for GSM
Investigational hormone-free vaginal insert for sexual pain post-menopause or breast cancer treatment. There are currently no FDA-approved vaginal hormone-free treatments for GSM.
Notable Publications¨
| Publication / Event | Author(s) | Title | Date |
|---|---|---|---|
| Climacteric (2023) | Thurman, et al. | Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy | 6/08/23 |
| International Journal of Pharmaceutics 570 (2019) 118691 | Chollet, et al. | Vaginal tamoxifen for treatment of vulvar and vaginal atrophy: Pharmacokinetics and local tolerance in a rabbit model over 28 days | 9/10/19 |
DARE-HPV^
Persistent High-Risk HPV Infection
Phase 2 Study Preparation
Phase 2
Potential first-in-category treatment for persistent high-risk HPV infection
Proprietary formulation of lopinavir and ritonavir for vaginal administration. There are currently no FDA-approved pharmacologic treatments for high-risk HPV infection.
| Publication / Event | Author(s) | Title | Date |
|---|---|---|---|
| PLoS ONE (2016) 11(1):e0147917 | Hampson, et al. | A Single-Arm, Proof-Of-Concept Trial of Lopimune (Lopinavir/Ritonavir) as a Treatment for HPV-Related Pre-Invasive Cervical Disease | 1/29/16 |
More Information
Potential first-in-category treatment for persistent high-risk HPV infection
Proprietary formulation of lopinavir and ritonavir for vaginal administration. There are currently no FDA-approved pharmacologic treatments for high-risk HPV infection.
Notable Publications¨
| Publication / Event | Author(s) | Title | Date |
|---|---|---|---|
| PLoS ONE (2016) 11(1):e0147917 | Hampson, et al. | A Single-Arm, Proof-Of-Concept Trial of Lopimune (Lopinavir/Ritonavir) as a Treatment for HPV-Related Pre-Invasive Cervical Disease | 1/29/16 |
DARE-PDM1^‡
Primary Dysmenorrhea
Phase 1 Study Completed
Phase 1
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.
| Publication / Event | Author(s) | Title | Date |
|---|---|---|---|
| Journal of Endometriosis and Pelvic Pain Disorders | Johnson, et al. | Safety, pharmacokinetics, and preliminary pharmacodynamics of 1% and 3% diclofenac vaginal hydrogel for the treatment of primary dysmenorrhea: a randomized, placebo controlled trial | 3/12/25 |
More Information
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.
Publications
| Publication / Event | Author(s) | Title | Date |
|---|---|---|---|
| Journal of Endometriosis and Pelvic Pain Disorders | Johnson, et al. | Safety, pharmacokinetics, and preliminary pharmacodynamics of 1% and 3% diclofenac vaginal hydrogel for the treatment of primary dysmenorrhea: a randomized, placebo controlled trial | 3/12/25 |
Casea S
Biodegradable Long-Acting Contraception
Collaborator: Theramex
Phase 1 Study Ongoing
Phase 1
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.
| PLoS ONE (2016) 11(1):e0147917 | Hampson, et al. | A Single-Arm, Proof-Of-Concept Trial of Lopimune (Lopinavir/Ritonavir) as a Treatment for HPV-Related Pre-Invasive Cervical Disease | 6/08/23 |
More Information
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
Phase 1 Study Preparation
Phase 1
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 injectable contraceptives indicated for 6 & 12 months of protection.
| Publication / Event | Author(s) | Title | Date |
|---|---|---|---|
| Contracept Reprod Med 10, 43 (2025) | Gottert, et al. | Acceptability of and preferences for long-acting injectable hormonal contraception among US women: evidence from a national cross-sectional online survey | 7/25/25 |
More Information
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 injectable contraceptives indicated for 6 & 12 months of protection.
Publications
| Publication / Event | Author(s) | Title | Date |
|---|---|---|---|
| Contracept Reprod Med 10, 43 (2025) | Gottert, et al. | Acceptability of and preferences for long-acting injectable hormonal contraception among US women: evidence from a national cross-sectional online survey | 7/25/25 |
DARE-FRT1/PTB1
Pregnancy Maintenance
Phase 1 Study Preparation
Phase 1
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.
| Publication / Event | Author(s) | Title | Date |
|---|---|---|---|
| Drug Delivery and Translational Research (2019) 9:1008–1016 | Weiss, et al. | Pharmacokinetics and tolerability of a novel progesterone intravaginal ring in sheep | 5/7/19 |
More Information
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.
Publications
| Publication / Event | Author(s) | Title | Date |
|---|---|---|---|
| Drug Delivery and Translational Research (2019) 9:1008–1016 | Weiss, et al. | Pharmacokinetics and tolerability of a novel progesterone intravaginal ring in sheep | 5/7/19 |
DARE-LARC1^
Long-Acting, Reversible Personal Contraceptive System
Pre-Clinical
Pre-Clinical
Potential 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.
| Drug Delivery and Translational Research (2019) 9:1008–1016 | Weiss, et al. | Pharmacokinetics and tolerability of a novel progesterone intravaginal ring in sheep | 5/7/19 |
More Information
Potential 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 About Our Clinical Trials
Explore Daré Bioscience’s life-changing solutions currently in development—with innovations to meet women’s health needs at every life stage.
^505(b)(2) regulatory pathway anticipated.
‡DARE-HRT1, DARE-VVA1, and DARE-PDM1 Phase 1 studies conducted in Australia by Daré subsidiary.
*As of 3/2/2026. This section includes forward-looking statements subject to qualifications described in the Terms of Service, including Section 16.4, 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.
Fueling Progress, One Insight at a Time
Dive into the latest news, peer-reviewed publications, and clinical trials shaping the future of women’s health.
News + Press Releases
Press Release: Daré Bioscience Reports Full Year 2025 Financial Results and Provides Business Update
March 26, 2026
News + Press Releases
Press Release: On National Viagra Day, Women Finally Claim Their Turn
March 23, 2026
News + Press Releases
Press Release: Daré Bioscience to Host Full Year 2025 Financial Results and Company Update Conference Call and Webcast on March 26, 2026
March 20, 2026
News + Press Releases
Press Release: Daré Bioscience Reports Full Year 2025 Financial Results and Provides Business Update
March 26, 2026
News + Press Releases
Press Release: On National Viagra Day, Women Finally Claim Their Turn
March 23, 2026
News + Press Releases
Press Release: Daré Bioscience to Host Full Year 2025 Financial Results and Company Update Conference Call and Webcast on March 26, 2026
March 20, 2026
