Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R21 Clinical Trial Optional)
Can you apply?
This grant is for research institutions and organizations developing precision medicine tools and novel therapeutics for pregnant women, lactating women, and children. Eligible applicants include universities, research hospitals, federal agencies, HBCUs, tribal colleges, faith-based and community-based organizations, and non-U.S. entities. The research must advance understanding of drug mechanisms during pregnancy, lactation, and childhood development.
Proposed projects should focus on translational or clinical research with direct health impact. This includes developing diagnostic tools, animal models, or other technologies. Drug repurposing, safety studies, and mechanism-of-action research are supported activities.
Projects may be offered as clinical trial optional, meaning clinical trial components enhance but are not required for funding.
This grant is for research institutions and organizations developing precision medicine tools and novel therapeutics for pregnant women, lactating women, and children. Eligible applicants include universities, research hospitals, federal agencies, HBCUs, tribal colleges, faith-based and community-based organizations, and non-U.S. entities. The research must advance understanding of drug mechanisms during pregnancy, lactation, and childhood development.
Proposed projects should focus on translational or clinical research with direct health impact. This includes developing diagnostic tools, animal models, or other technologies. Drug repurposing, safety studies, and mechanism-of-action research are supported activities.
Projects may be offered as clinical trial optional, meaning clinical trial components enhance but are not required for funding.
Program description
The purpose of this notice of funding opportunity (NOFO) is to support translational and clinical research to (1) advance precision medicine in pregnant women, lactating women, and children through the development of novel tools, models, and other technologies that could have a direct clinical or health impact; (2) enhance the understanding of the underlying mechanisms of drug action, including the role of pediatric ontogeny and the dynamic physiological changes that occur during pregnancy and lactation; and (3) discover and develop novel therapeutics or enhance the usage of existing drugs or drug repurposing for safer and more effective medications in pregnant and lactating women, neonates, and children. The overall goal is to improve safe and effective precision therapeutics for pregnant and lactating women, fetuses, neonates, and children, including those with disabilities.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Faith-based Organization
- HBCU
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- TCU (Tribal Colleges)
- Tribal Nation
- Tribal Organization
Demographic focus
Details
This grant is for research institutions and organizations developing precision medicine tools and novel therapeutics for pregnant women, lactating women, and children. Eligible applicants include universities, research hospitals, federal agencies, HBCUs, tribal colleges, faith-based and community-based organizations, and non-U.S. entities. The research must advance understanding of drug mechanisms during pregnancy, lactation, and childhood development.
Proposed projects should focus on translational or clinical research with direct health impact. This includes developing diagnostic tools, animal models, or other technologies. Drug repurposing, safety studies, and mechanism-of-action research are supported activities.
Projects may be offered as clinical trial optional, meaning clinical trial components enhance but are not required for funding.
How to apply
Application links
Required documents
- PHS 398 (NIH Application Form) or SF-424 with Zucker R&D supplement
- Project Narrative (research strategy)
- Biographical Sketches (key personnel)
- Budget Justification
- Facilities and Resources
- Letters of Support (clinical sites, collaborators)
- Animal Care and Use Protocol (IACUC) if applicable
- Human Subjects Research Protocol (IRB) if applicable
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.855 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$438,527,853
-
$246,626,852
-
$204,359,786
-
$201,437,825
-
$200,221,259
-
$185,816,804
-
$180,737,624
-
$136,265,880
-
$116,817,868
-
$99,478,296
Top States by Funding
- CA 10 awards $812.7M
- WA 3 awards $684.0M
- MA 6 awards $602.8M
- NC 3 awards $446.4M
- NY 7 awards $375.7M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
FAQ
What types of organizations can apply?
Universities, research hospitals, HBCUs, tribal colleges, federal agencies, faith-based organizations, and non-U.S. entities are eligible. Foreign organizations can apply.
What research areas are supported?
Precision medicine for pregnant/lactating women and children. Drug development, mechanism studies, and novel therapeutic discovery are priorities. Clinical trials are optional.
When is the deadline?
The deadline is July 6, 2026. Plan ahead for internal review and institutional approvals.
What makes an application competitive?
Strong preliminary data, clear clinical relevance, multidisciplinary teams, and focus on underserved populations strengthen applications. Include feasibility plans for recruitment.
Can I study drug safety in pregnancy?
Yes. Safety studies, pharmacokinetics, and understanding physiological changes during pregnancy and lactation are core research areas.
💡 Tips for applicants
- Establish preliminary data early. NIH values proof-of-concept before funding larger projects. Even small pilot studies strengthen your narrative.
- Build multidisciplinary teams. Combine expertise in pharmacology, pediatrics, obstetrics, and relevant clinical specialties for reviewer credibility.
- Address health equity explicitly. Specify how your research benefits underrepresented populations, including pregnant individuals and children with disabilities.
- Plan recruitment carefully. Detail how you will enroll pregnant women or children safely. Include institutional support letters from clinical partners.
- Use the R21 format strategically. This mechanism supports exploratory work. Frame your project as proof-of-concept for a larger R01 eventually.
⚠️ Common mistakes
Submitting without preliminary data or feasibility studies. Reviewers view exploratory work skeptically without evidence the approach will work. Failing to address safety and ethical considerations for vulnerable populations like pregnant women and children. Proposing research without clear clinical or health relevance; basic mechanistic studies alone are less competitive.
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