This section highlights FDA-related milestones and regulatory updates for drugs developed by Dare Bioscience (DARE).
Over the past two years, Dare Bioscience has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DARE-PTB1, DARE-HPV, Ovaprene, and Sildenafil. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
DARE-PTB1 FDA Regulatory Events
DARE-PTB1 is a drug developed by Dare Bioscience for the following indication: Treatment for the prevention of preterm birth.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DARE-PTB1
- Announced Date:
- March 16, 2026
- Indication:
- Treatment for the prevention of preterm birth
Announcement
Daré Bioscience, Inc. announced receipt of a revised Notice of Award from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a division of the National Institutes of Health (NIH), relating to the approximately $2.0 million funding award for DARE-PTB1, Daré's investigational intravaginal ring (IVR) for the prevention of preterm birth.
AI Summary
Daré Bioscience announced that the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) issued a revised Notice of Award extending the budget period for the approximately $2.0 million grant for DARE-PTB1 through November 30, 2026 at no additional cost. The revised award (5R44HD101169-03) covers the project that began December 12, 2023 and supports a Phase 1 comparative pharmacokinetics clinical study of DARE-PTB1 in at-risk women, consistent with a no-cost extension request submitted in November 2025.
DARE-PTB1 is an investigational intravaginal ring that delivers bio-identical progesterone continuously for up to 14 days and is being developed to reduce the risk of preterm birth, a condition with no approved treatment options. Daré says the award reflects its strategy of leveraging non-dilutive grant funding to advance a differentiated women’s health pipeline and move clinical programs forward without additional federal expense.
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DARE-HPV FDA Regulatory Events
DARE-HPV is a drug developed by Dare Bioscience for the following indication: For HPV-related cervical diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DARE-HPV
- Announced Date:
- February 23, 2026
- Indication:
- For HPV-related cervical diseases
Announcement
Daré Bioscience, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for DARE-HPV, an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert, allowing initiation of a planned Phase 2 clinical study to evaluate DARE-HPV as a potential treatment for persistent high-risk human papillomavirus (HPV) infection.
AI Summary
The U.S. Food and Drug Administration has cleared Daré Bioscience’s Investigational New Drug (IND) application for DARE-HPV, an investigational proprietary fixed‑dose formulation of lopinavir and ritonavir in a soft‑gel vaginal insert. This clearance allows Daré to begin a planned Phase 2 clinical study to evaluate DARE‑HPV as a potential treatment for persistent high‑risk human papillomavirus (HPV) infection. DARE‑HPV is being developed as a non‑surgical, localized, self‑administered therapy aimed at clearing persistent high‑risk HPV.
HPV causes 99% of cervical cancer cases in the United States, and there are currently no FDA‑approved drug treatments for HPV infection. By targeting the virus itself rather than waiting for cells to change, DARE‑HPV could change how cervical disease is prevented. The Phase 2 study will assess safety and antiviral activity in women with persistent high‑risk HPV. The program is supported by a $10 million ARPA‑H contract, $6.5 million of which has been received, and Daré is preparing to start the trial in 2026.
Read Announcement- Drug:
- DARE-HPV
- Announced Date:
- February 6, 2025
- Indication:
- For HPV-related cervical diseases
Announcement
Daré Bioscience, announced that it received a Notice of Award of a grant from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH).
AI Summary
Daré Bioscience recently received a Notice of Award for a grant from the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH. This funding award, potentially totaling up to $2 million, will support non-clinical development activities for its investigational treatment, DARE-HPV. DARE-HPV is being developed as a first-in-category treatment for HPV-related cervical disease, which is linked to nearly all cases of cervical cancer worldwide. The treatment aims to offer a novel, at-home option for managing HPV infections and cervical precancers, potentially avoiding the high-risk surgeries currently used. In the 2025 project year, Daré Bioscience has already been awarded $1 million, with an additional $1 million recommended for a subsequent year, pending fund availability and satisfactory project progress. This grant is a key step toward transforming the clinical management of HPV-related cervical diseases.
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Ovaprene FDA Regulatory Events
Ovaprene is a drug developed by Dare Bioscience for the following indication: Intravaginal Contraceptive.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Ovaprene
- Announced Date:
- December 1, 2025
- Indication:
- Intravaginal Contraceptive
Announcement
Daré Bioscience, Inc. announced that all rights to Ovaprene®, the company's first-in-category, investigational, hormone-free monthly intravaginal contraceptive, will be returned to Daré by Bayer HealthCare LLC as a result of Bayer electing to terminate the license agreement between the parties as part of a strategic prioritization.
AI Summary
Daré Bioscience announced that Bayer HealthCare will return all rights to Ovaprene after electing to terminate their license agreement as part of a strategic prioritization. The termination becomes effective in February 2026. Because the Phase 3 program is being funded with non-dilutive grants, the return gives Daré full control of this late-stage, hormone-free monthly intravaginal contraceptive and lets the company steer the remainder of development and commercialization efforts.
Daré highlighted positive interim Phase 3 data from July 2025 showing consistent safety, tolerability, and pregnancy rates in line with expectations. Consolidating global rights under Daré increases strategic flexibility to seek partnerships, alternative commercialization models, or to retain greater long-term economics. The company expects Phase 3 enrollment to finish in 2026 and the trial continues with previously announced external grant support, including funding from the Gates Foundation. Daré says the move strengthens its position with a differentiated asset in a large market with unmet need.
Read Announcement- Drug:
- Ovaprene
- Announced Date:
- July 14, 2025
- Indication:
- Intravaginal Contraceptive
Announcement
Daré Bioscience, Inc. announced positive interim safety and efficacy results from its ongoing Phase 3 clinical trial evaluating the contraceptive effectiveness, safety and acceptability of Ovaprene®, the company's investigational monthly, hormone-free intravaginal contraceptive.
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Sildenafil Cream FDA Regulatory Timeline and Events
Sildenafil Cream is a drug developed by Dare Bioscience for the following indication: Women with Female Sexual Arousal Disorder.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Sildenafil Cream
- Announced Date:
- July 29, 2025
- Indication:
- Women with Female Sexual Arousal Disorder
Announcement
Daré Bioscience, Inc. announced the launch of the first phase of a consumer awareness campaign to support the upcoming introduction of DARE to PLAY Sildenafil Cream.
AI Summary
Daré Bioscience and Rosy Wellness this week launched the first phase of a consumer awareness campaign to support the upcoming introduction of DARE to PLAY Sildenafil Cream. The effort uses evidence-based mobile content to reach women with clear, engaging information about sexual arousal and wellness.
DARE to PLAY is a topical sildenafil cream shown in clinical studies to boost genital blood flow and improve sexual response in women. It uses the same active ingredient as Viagra® but is formulated specifically for female use.
The campaign features “Quickies,” short videos reviewed for clinical accuracy and hosted on Rosy’s platform. These clips deliver trustworthy facts and tackle myths about arousal. A featured Quickie, led by Dr. Sameena Rahman, explains the biology of female arousal and how DARE to PLAY works.
An Arousal Collection offers interactive, expert-led modules with quizzes and resources. Both tools aim to empower women with reliable sexual health education.
DARE to PLAY Sildenafil Cream is targeted for prescription availability in the U.S. in the fourth quarter of 2025 under Section 503B of the FD&C Act.
Read Announcement- Drug:
- Sildenafil Cream
- Announced Date:
- December 16, 2024
- Indication:
- Women with Female Sexual Arousal Disorder
Announcement
Daré Bioscience, announced plans for a Phase 3 study of Sildenafil Cream, 3.6%, an investigational topical cream formulation of sildenafil being developed as an on-demand treatment for female sexual arousal disorder (FSAD), reflecting U.S. Food and Drug Administration (FDA) feedback for safety and efficacy evaluations to support the indication of treatment of FSAD in premenopausal women.
AI Summary
Daré Bioscience announced plans to launch a Phase 3 study for its investigational Sildenafil Cream, 3.6%, an on-demand treatment for female sexual arousal disorder (FSAD) in premenopausal women. The Phase 3 study design reflects recent U.S. FDA feedback on safety and efficacy evaluations needed for the treatment indication. Daré Bioscience will submit the protocol and statistical analysis plan in the first quarter of 2025 and hopes to start the study by mid-2025. This trial builds on positive findings from previous Phase 2b studies and aims to assess improvements in genital arousal sensations and associated distress via objective, well-controlled endpoints. If successful, Sildenafil Cream could become the first FDA-approved treatment for FSAD, addressing an unmet need among women experiencing sexual dysfunction.
Read Announcement- Drug:
- Sildenafil Cream
- Announced Date:
- December 10, 2024
- Indication:
- Women with Female Sexual Arousal Disorder
Announcement
Daré Bioscience, announced that additional data from the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6%, an investigational topical cream formulation of sildenafil being developed as an on-demand treatment for female sexual arousal disorder (FSAD), has been published by Sexual Medicine, an official publication of the International Society for Sexual Medicine.
AI Summary
Daré Bioscience announced that additional findings from its exploratory Phase 2b RESPOND clinical study evaluating Sildenafil Cream, 3.6% for female sexual arousal disorder (FSAD) have been published in Sexual Medicine, the official publication of the International Society for Sexual Medicine. The study explored how factors like age, race, and hormonal contraceptive use influence the cream’s efficacy. Results indicated that neither age nor race significantly altered patients’ responses to the treatment. Moreover, hormonal contraceptive users showed similar improvements as non-users, suggesting that the cream could benefit a wide range of premenopausal women struggling with FSAD.
The findings help refine the target population for future research and highlight the cream’s potential as an on-demand treatment for FSAD. Daré Bioscience believes these results strengthen the case for further development of Sildenafil Cream as a safe and effective option for women experiencing sexual arousal difficulties.
Read Announcement- Drug:
- Sildenafil Cream
- Announced Date:
- August 26, 2024
- Indication:
- Women with Female Sexual Arousal Disorder
Announcement
Daré Bioscience announced that safety and tolerability data from the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6%, an investigational topical cream formulation of sildenafil being developed as an on-demand treatment for female sexual arousal disorder (FSAD), has been published by The Journal of Sexual Medicine.
AI Summary
Daré Bioscience recently announced that safety and tolerability data from the exploratory Phase 2b RESPOND study of Sildenafil Cream, 3.6% have been published by The Journal of Sexual Medicine. In the study, the topical cream—designed as an on-demand treatment for female sexual arousal disorder (FSAD)—was found to be safe and well tolerated by both the women using it and their partners. Data from 1,357 sexual experiences showed that the cream did not cause the common side effects seen with oral sildenafil, such as headache and flushing. Researchers believe that the lower systemic exposure from the topical application played a role in avoiding these side effects. These promising findings support Daré Bioscience’s ongoing discussions with the FDA and further clinical development planned for a Phase 3 program aimed at addressing FSAD.
Read Announcement- Drug:
- Sildenafil Cream
- Announced Date:
- August 13, 2024
- Indication:
- Women with Female Sexual Arousal Disorder
Announcement
Daré Bioscience, announced that additional data from the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6%, an investigational topical cream formulation of sildenafil being developed as an on-demand treatment for female sexual arousal disorder (FSAD), has been published by The Journal of Sexual Medicine.
AI Summary
Daré Bioscience announced that additional data from its exploratory Phase 2b RESPOND clinical study for Sildenafil Cream, 3.6% has been published in The Journal of Sexual Medicine. The study explored the treatment’s impact on female sexual arousal disorder (FSAD) using patient reported outcomes. Researchers compared a 1‑month recall method with a 24‑hour recall method, and the results showed similar responses from both methods. This finding is important because a 1‑month recall is less burdensome for patients and may lead to better compliance in future studies. Sabrina Martucci Johnson, President and CEO, and the study team highlighted that the strong correlation between the two assessment methods offers flexibility for measuring treatment efficacy. These promising results support ongoing efforts to develop Sildenafil Cream as a safe, on‑demand treatment option for women with FSAD.
Read Announcement- Drug:
- Sildenafil Cream
- Announced Date:
- June 24, 2024
- Indication:
- Women with Female Sexual Arousal Disorder
Announcement
Daré Bioscience, announced the publication in Obstetrics & Gynecology, the official publication of the American College of Obstetricians and Gynecologists (ACOG), of the Phase 2b study efficacy results of topical Sildenafil Cream 3.6% (Sildenafil Cream), which is being developed for the treatment of female sexual arousal disorder (FSAD).
AI Summary
Daré Bioscience announced that its Phase 2b study results for topical Sildenafil Cream 3.6% have been published in Obstetrics & Gynecology, the official journal of the American College of Obstetricians and Gynecologists (ACOG). The study, a multi-center, double-blind, placebo-controlled trial in premenopausal women with female sexual arousal disorder (FSAD), showed promising results. In particular, an exploratory subset of participants—with or without decreased desire—experienced significant improvements. The cream helped increase sexual arousal sensations, reduced sexual distress, and enhanced desire and the ability to reach orgasm.
These findings highlight the potential of Sildenafil Cream to address an unmet need in women’s sexual health, as FSAD affects nearly 20% of women in the U.S. The publication in a reputable, peer-reviewed journal further supports the promise of this novel treatment approach for improving the outcomes of women with FSAD.
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