相关临床试验
11
1 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2005
已完成
8
72.7%
尚未招募
1
9.1%
招募中
2
18.2%
暂无批准数据
- Daré Bioscience announced positive interim Phase 3 results for Ovaprene, showing approximately 9% pregnancy rate among 339 study participants across 1,789 menstrual cycles. - The independent Data Safety Monitoring Board recommended continuing the study without modification, marking the second positive review since July 2025. - Ovaprene represents a potential first-in-category hormone-free, monthly intravaginal contraceptive with no serious device-related adverse events identified. - Study discontinuation due to vaginal odor decreased to 12% from previous analysis, while majority of participants reported likelihood to use Ovaprene if available.
- Daré Bioscience received FDA clearance for its IND application to initiate a Phase 2 clinical study of DARE-HPV, a novel vaginal insert formulation targeting persistent high-risk HPV infection. - DARE-HPV represents a potential breakthrough as the first FDA-approved pharmacologic treatment for HPV infection, which causes 99% of cervical cancer cases in the United States. - The development program is supported by a $10 million ARPA-H contract, with the Phase 2 study expected to evaluate safety and antiviral activity in women with persistent high-risk HPV infection. - The therapy aims to transform cervical disease prevention by targeting the virus directly rather than waiting for precancerous lesions to develop, potentially eliminating the current "watch and wait" approach.
- Daré Bioscience has launched DARE to PLAY™ Sildenafil Cream, the first evidence-based topical arousal cream specifically developed for women, now available by prescription in 10 U.S. states. - The non-hormonal cream uses sildenafil to increase genital blood flow within 10-15 minutes and improve arousal sensations, backed by clinical trials including a randomized placebo-controlled study with 200 women. - The product addresses a significant unmet medical need, as an estimated 20 million women in the United States experience challenges related to genital arousal with no FDA-approved therapeutics currently available. - DARE to PLAY™ is manufactured through a 503B outsourcing facility under cGMP requirements while the company continues pursuing FDA approval for its proprietary formulation.
- Daré Bioscience is preparing to launch DARE to PLAY Sildenafil Cream in December 2025 through a 503B compounding pathway, marking the company's first revenue-generating product. - The company received positive interim safety data from an independent monitoring board for its Phase 3 Ovaprene contraceptive study, with pregnancy rates meeting expectations and enrollment continuing. - Four women's health products are expected to become commercially available over the next two years, including vaginal probiotics and hormone therapy solutions targeting underserved markets. - The company reported improved financial metrics with $23.1 million in cash and reduced R&D expenses of 56% year-over-year, while advancing multiple grant-funded programs for HPV treatment and contraception.
- XOMA Royalty Corporation reported robust financial performance in Q3 2025, receiving $43.9 million in royalties and milestones from partners in the first nine months of 2025, including $14.3 million in Q3 royalties. - The company completed strategic acquisitions of Turnstone Biologics and HilleVax while announcing planned acquisitions of LAVA Therapeutics and Mural Oncology to expand its royalty portfolio. - Key pipeline developments include Zevra Therapeutics submitting a Marketing Authorization Application to the EMA for arimoclomol in Niemann-Pick Type C disease and Rezolute Bio expecting Phase 3 ersodetug trial results in December 2025. - XOMA Royalty achieved net income of $14.1 million in Q3 2025 compared to a net loss of $17.2 million in the same period of 2024, demonstrating improved operational performance.
- Daré Bioscience announced positive interim safety and efficacy results from its Phase 3 trial of Ovaprene, an investigational monthly hormone-free intravaginal contraceptive. - The trial's independent Data Safety Monitoring Board recommended the study continue without modification after finding approximately 9% pregnancy rate, consistent with company expectations. - No serious safety concerns were identified, though 17% of participants discontinued due to vaginal odor, and participants reported they would likely use Ovaprene if available. - Bayer holds rights to commercialize the product in the U.S. following completion of the pivotal trial, with potential payments up to $310 million in milestones plus royalties.
- Daré Bioscience received a $6 million non-dilutive grant installment, bringing total funding to $37.8 million of up to $49 million committed for DARE-LARC1 contraceptive development. - The DARE-IDDS platform features a programmable, wirelessly controlled device capable of delivering hundreds of individualized doses over months or years without recharging or surgical replacement. - Originally developed at MIT by Dr. Robert Langer and Dr. Michael Cima, the platform has broader therapeutic potential beyond contraception, including obesity, diabetes, and neurologic diseases. - The company is exploring strategic partnerships to expand the platform's application beyond reproductive health into multibillion-dollar therapeutic markets.
- Daré Bioscience has unveiled a dual-path approach to make its proprietary Sildenafil Cream formulation available via prescription by Q4 2025, responding to healthcare community urging and women's demand. - The company is exploring a 503B compounding pathway to accelerate market access for its female sexual arousal disorder (FSAD) treatment, potentially creating the first FDA-approved therapy for this condition. - CEO Sabrina Martucci Johnson will present the expanded business strategy at the Jones Healthcare and Technology Innovation Conference, with plans to evaluate similar approaches for other proprietary formulations in their portfolio.
• XOMA Royalty doubled its portfolio to over 120 royalty assets through five strategic transactions in 2024, strengthening its position as a biotech royalty aggregator. • The company completed two whole company acquisitions and celebrated FDA approvals for Day One's OJEMDA™ (tovorafenib) and Zevra's MIPLYFFA™ (arimoclomol), generating significant milestone payments. • Despite reporting a net loss of $13.8 million for 2024, XOMA Royalty received $46.3 million in cash receipts and maintains over $100 million in cash, positioning it for sustainable cashflow from royalties.
- Daré Bioscience and Theramex have entered into a co-development agreement for Casea S, a first-in-category biodegradable contraceptive implant designed to last 18-24 months. - The innovative implant eliminates the need for surgical removal, addressing a key barrier in current contraceptive implants while offering women a convenient, long-acting contraceptive option. - A foundation-funded Phase 1 trial is currently underway to evaluate the pharmacokinetics, removability, safety, and tolerability of Casea S.
