Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R21 Clinical Trial Optional) | PAR 25 111

Opportunity Information: Apply for PAR 25 111

The Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R21 Clinical Trial Optional) opportunity (Funding Opportunity Number PAR 25-111) is a National Institutes of Health (NIH) discretionary grant solicitation that supports early-stage, exploratory translational and clinical research aimed at improving how medications are developed, selected, dosed, and used in pregnant people, lactating people, and children. Using the NIH R21 mechanism, the program is geared toward innovative, higher-risk ideas that can generate strong proof-of-concept data or open up new directions for maternal and pediatric pharmacology and therapeutics. Clinical trials are allowed but not required, which means applicants can propose anything from preclinical translational studies through carefully justified clinical research, as long as the work is positioned to meaningfully influence health outcomes and move the field toward more precise and safer treatments.

The scientific focus centers on three major aims. First, the NOFO seeks projects that advance precision medicine for pregnancy, lactation, and pediatrics by creating or refining tools, models, or technologies with clear potential for clinical or public health impact. This can include novel experimental systems, predictive models, biomarkers, assay platforms, or other enabling technologies that help clinicians tailor therapy to individual patients or subpopulations. Second, it encourages deeper mechanistic understanding of how drugs work in these populations, emphasizing two critical realities that often complicate treatment: pediatric ontogeny (how developmental stage changes drug absorption, distribution, metabolism, and response over time) and the dynamic physiological changes associated with pregnancy and lactation (which can substantially alter pharmacokinetics, pharmacodynamics, and safety profiles). Third, it supports the discovery or development of new therapeutics, as well as strategies to improve use of existing drugs, including repurposing, with the explicit goal of producing safer and more effective medication options for pregnant and lactating people, fetuses, neonates, and children.

The overall intent is practical and patient-centered: to improve the safety and effectiveness of precision therapeutics in maternal and pediatric care, including for individuals with disabilities. In many therapeutic areas, pregnant and lactating people and children are underrepresented in research and clinical trials, leading to gaps in dosing guidance, safety data, and evidence-based prescribing. This NOFO is designed to help close those gaps by funding studies that clarify drug action and variability, build translational bridges from lab findings to clinical application, and accelerate the availability of evidence that can be used in real-world care settings.

Eligibility is broad and inclusive, spanning governmental, academic, nonprofit, and commercial sectors. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; and small businesses. The NOFO also explicitly highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; U.S. territories or possessions; regional organizations; Indian/Native American tribal governments other than federally recognized; and non-U.S. entities (foreign organizations). This wide eligibility reflects the program's interest in fostering collaboration and bringing in expertise from diverse institutions and communities, including those that serve populations often most affected by disparities in maternal and pediatric health.

Administratively, the opportunity is listed under CFDA numbers 93.279, 93.313, 93.855, and 93.865 and is offered as a grant funding instrument. The original closing date provided is 2026-05-07, and the opportunity record indicates a creation date of 2024-11-18. While the excerpted source data does not specify an award ceiling or expected number of awards, the R21 format generally signals a smaller, time-limited project intended to test bold concepts and generate key data that can justify larger follow-on studies.

In practical terms, competitive projects under this NOFO will usually be those that directly address a well-defined maternal or pediatric therapeutic problem, explain why current evidence is insufficient for these populations, and propose a translational pathway that links the research outputs to actionable changes in drug development, dosing, safety monitoring, or treatment selection. Whether the work focuses on model development, mechanistic pharmacology, biomarker-driven precision therapeutics, or repurposing and optimization of existing medications, the common expectation is that the results should move the field toward more reliable, individualized, and safer medication use across pregnancy, lactation, and childhood, including the neonatal period.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R21 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279, 93.313, 93.855, 93.865.
• This funding opportunity was created on 2024-11-18.
• Applicants must submit their applications by 2026-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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