# A novel intravaginal ring technology featuring the sustained release of natural progesterone for the prevention of preterm birth in at-risk women

> **NIH NIH R44** · DARE BIOSCIENCE, INC. · 2020 · $299,696

## Abstract

In the United States, one in ten babies is born prematurely. The earlier in pregnancy a baby is born, the more
likely s/he will have an extended hospital stay, as well as serious health complications such as respiratory
distress syndrome, necrotizing enterocolitis, vision problems and infection. Women who have had a previous
premature birth and women diagnosed with a short cervix in mid pregnancy are at high risk for preterm birth, and
are typically prescribed a progesterone product to reduce this risk. There are currently only two general
progesterone products available to women at risk for pre-term birth, each having drawbacks associated with
variable efficacy and ease of use. Moreover, none of the available progesterone products have received approval
from the Federal Drug Administration for use in pregnant women diagnosed with a short cervix. To improve
treatment options for women having one or both clinical risk factors for a preterm birth, Daré Bioscience is
advancing the development of a novel intravaginal ring, called DARE-FRT1. DARE-FRT1 offers women a
patient-friendly, extended-release progesterone product that delivers a relatively constant level of the drug in
close proximity to the cervix, where progesterone action regulates inflammation, contractility, and other activities
associated with labor. An in vivo preclinical study demonstrated that DARE-FRT1 slowly releases bioidentical
progesterone over at least 14 days. Building on these strong foundational studies we aim to (i) complete IND-
enabling in vitro DARE-FRT1 product stability studies to ensure consistent and product and (ii) evaluate the
comparative pharmacokinetics of different DARE-FRT1 doses in a first-in-human clinical study. Thus, DARE-
FRT1 holds promise to be the first simple, safe, and convenient method to extend the term of gestation in women
at high risk for preterm birth, improving overall health outcomes, and reducing infant mortality.

## Key facts

- **NIH application ID:** 10004392
- **Project number:** 1R44HD101169-01A1
- **Recipient organization:** DARE BIOSCIENCE, INC.
- **Principal Investigator:** DAVID R FRIEND
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $299,696
- **Award type:** 1
- **Project period:** 2020-08-18 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10004392

## Citation

> US National Institutes of Health, RePORTER application 10004392, A novel intravaginal ring technology featuring the sustained release of natural progesterone for the prevention of preterm birth in at-risk women (1R44HD101169-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10004392. Licensed CC0.

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