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-HPV, Ovaprene, and Sildenafil. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
DARE-HPV - FDA Regulatory Timeline and 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 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 Timeline and 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:
- April 11, 2024
- Indication:
- Intravaginal Contraceptive
Announcement
Daré Bioscience announced the publication of data from the postcoital test clinical study of Ovaprene in two original research articles in the journal Contraception.
AI Summary
Daré Bioscience announced that its hormone‐free contraceptive candidate, Ovaprene, has shown promising results in a postcoital test study of 33 women. The data were published in two original research articles in the journal Contraception. The studies revealed that Ovaprene was safe and effective, as it prevented nearly all sperm from entering the cervical canal—a key indicator of contraceptive efficacy. Additionally, the results showed that Ovaprene did not disrupt the vaginal microbiome.
These positive findings have supported the advancement to a pivotal Phase 3 clinical study, which is currently enrolling participants across the United States. If the upcoming trial confirms its effectiveness over 13 menstrual cycles, Ovaprene could become the first FDA-approved, hormone-free monthly intravaginal contraceptive, offering a new non-hormonal birth control option for women.
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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:
- 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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