Preterm birth remains one of the leading causes of death in children under five worldwide, yet women and their doctors still have no FDA-approved preventive option to turn to. Now, a biotech company called Daré Bioscience has received a $2 million funding award from the National Institutes of Health (NIH) to advance DARE-PTB1, an investigational intravaginal ring designed to deliver bio-identical progesterone continuously for up to 14 days to reduce the risk of preterm birth in at-risk women. What Is DARE-PTB1 and How Does It Work? DARE-PTB1 is a novel intravaginal ring, or IVR, that represents a fundamentally different approach to preventing preterm birth. The device is designed to deliver bio-identical progesterone, a hormone naturally produced by the body, directly where it's needed most. Unlike systemic treatments that circulate throughout the entire body, this localized delivery method allows for continuous hormone release over a two-week period. The technology behind DARE-PTB1 builds on important learnings from the company's earlier work with hormone delivery. David Friend, PhD, Chief Scientific Officer of Daré Bioscience, explained the connection: "DARE-PTB1 benefits from important learnings from our DARE-HRT1 program, which generated positive pharmacokinetic results in Phase 1 and Phase 1/2 clinical trials using the same IVR platform technology to deliver bio-identical hormones. This continued NICHD support enables us to apply those insights to the preterm birth indication and advance the clinical work necessary to develop a first-of-its-kind FDA-approved preventive treatment for at-risk women". Why Is This Research Significant for Women's Health? Preterm birth, defined as delivery before 37 weeks of pregnancy, affects hundreds of thousands of women annually and carries serious health consequences. The condition is the leading cause of death in children under five globally, yet the treatment landscape remains remarkably limited. Currently, there are no FDA-approved medications or devices specifically designed to prevent preterm birth in at-risk populations. This funding award from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a division of the NIH, reflects recognition of a critical gap in women's health innovation. The revised Notice of Award extends the budget period through November 2026, with approximately $2 million in total federal funding across the project period, which began in December 2023. What Does the Current Research Phase Involve? The NIH grant supports a Phase 1 comparative pharmacokinetics clinical study of DARE-PTB1 in at-risk women. Pharmacokinetics refers to how the body absorbs, distributes, and eliminates a drug or hormone. This early-stage research is essential for understanding how the intravaginal ring delivers progesterone and how the body responds to this delivery method. Daré Bioscience's approach to advancing DARE-PTB1 reflects a broader strategy within the company. The organization has deliberately assembled a portfolio addressing some of the most underfunded and underserved categories in women's health. This includes not only preterm birth prevention but also treatments for sexual dysfunction, new contraceptive choices, and prevention of HPV-associated disease. How Is Daré Bioscience Funding This Research? One of the most distinctive aspects of Daré's strategy is its use of non-dilutive grant funding, meaning money that doesn't require giving up equity or control of the company. By securing strategic partnerships with the NIH and other research institutions, the company can advance multiple programs toward clinical trials simultaneously without the typical capital constraints that slow women's health innovation. Sabrina Martucci Johnson, President and CEO of Daré Bioscience, emphasized the importance of this approach: "The continued commitment of the NIH to this project validates what we have long believed about DARE-PTB1: that it has the potential to address a real, urgent, and underserved clinical need. Every dollar of grant funding we secure is a dollar that moves us closer to putting better options in women's hands". Steps to Understanding Clinical Trial Development for Women's Health - Phase 1 Research: Early-stage studies that test how a new treatment is absorbed and processed by the body, typically involving small groups of healthy volunteers or at-risk patients to establish safety and dosage. - Pharmacokinetic Analysis: Detailed examination of how the body handles the drug or hormone, including absorption rates, distribution patterns, and elimination timelines to optimize delivery. - Comparative Studies: Research that measures the new treatment against existing standards or placebo to determine effectiveness and safety in the target population. The development of DARE-PTB1 represents a significant shift in how women's health research is being prioritized and funded. For decades, women's health has received disproportionately less research investment compared to other medical fields, leaving critical gaps in preventive and treatment options. The NIH's continued support of this project signals a growing recognition that these gaps must be addressed with the same scientific rigor and resources dedicated to other health conditions. As DARE-PTB1 advances through its clinical trial phases, the potential impact extends beyond the individual women who might eventually use the device. Success in developing the first FDA-approved preventive treatment for preterm birth could reshape how the medical community approaches pregnancy complications and establish a new standard for women-centered medical innovation. For now, the research continues, supported by the NIH's commitment to closing the gap between promising science and real-world solutions for women's health.
