Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional) | PAR 25 110

Opportunity Information: Apply for PAR 25 110

The National Institutes of Health (NIH) is offering the Translational Research in Maternal and Pediatric Pharmacology and Therapeutics program (PAR-25-110), an R01 grant opportunity where clinical trials are optional. This funding is aimed at supporting translational and clinical research that directly improves how medications are developed, evaluated, and used for pregnant persons, lactating persons, and pediatric populations, including fetuses, neonates, and children. A central theme of the opportunity is precision therapeutics, meaning research that helps tailor drug choice and dosing to the biology and physiology of these populations rather than relying on data extrapolated from non-pregnant adults.

The NOFO highlights three major scientific goals. First, it seeks projects that advance precision medicine by creating or improving tools, models, or enabling technologies with clear potential to influence clinical care or health outcomes. In practice, this could include new experimental systems, computational approaches, biomarkers, pharmacometric models, or other translational platforms that help predict drug exposure, response, or safety in pregnancy, lactation, or childhood. Second, it supports research that clarifies mechanisms of drug action and variability, with explicit attention to pediatric ontogeny (how growth and development change drug absorption, distribution, metabolism, and elimination) and the rapidly changing physiology associated with pregnancy and lactation. Third, it encourages efforts to discover and develop novel therapeutics or to make existing therapies safer and more effective through strategies such as optimized dosing, improved labeling evidence, or drug repurposing specifically for pregnant and lactating persons and for neonates and children.

The overall intent is to close longstanding evidence gaps in maternal and pediatric pharmacology, where real-world prescribing often outpaces the available data. NIH is looking for projects that can move the field toward safer and more effective medication use by generating actionable evidence, whether that is through translational research that leads to clinically relevant tools or through clinical research that improves understanding of dosing, response, and safety. The NOFO also explicitly includes populations with disabilities within its scope, reinforcing an inclusive approach to research priorities and expected impacts.

This is a discretionary grant program using the NIH R01 mechanism, and the activity areas align with health-related research and services (listed under CFDA numbers 93.242, 93.279, 93.313, 93.855, and 93.865). Clinical trials may be proposed but are not required, which allows applicants to pursue a range of study designs from preclinical or translational model development through human pharmacology studies and other clinical research approaches, as long as the work remains strongly connected to improving therapeutics in the stated populations.

Eligibility is broad and includes many types of domestic applicants such as state, county, and local 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 that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The announcement also names additional eligible applicant categories that NIH is explicitly welcoming, including 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, regional organizations, non-domestic (non-U.S.) entities (foreign organizations), and applicants from U.S. territories or possessions.

The opportunity was created on November 18, 2024, and the listed original closing date is May 7, 2026. The source information does not specify an award ceiling or the expected number of awards in the provided fields, so applicants would need to consult the full NOFO and NIH budget guidance for allowable costs, project period expectations, and any institute- or center-specific priorities tied to this PAR.

• 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 (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 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.

Apply for PAR 25 110

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