Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for researchers and institutions conducting early-phase clinical trials of natural products. Eligible applicants include academic institutions, research organizations, faith-based entities, federally recognized tribal entities, and tribal colleges. Projects must test botanicals, probiotics, dietary supplements, or standardized nutritional compounds with strong preliminary evidence. The grant supports U.S.-based research only; non-domestic components are not eligible.
Research must involve human subjects and focus on pharmacokinetics, bioavailability, mechanism of action, and target engagement. The R61 phase (up to 3 years) funds initial testing. The R33 phase (up to 3 additional years) funds replication and optimization studies if R61 milestones are met.
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Program description
This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, probiotics, and products marketed as dietary supplements), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. Under this NOFO, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product.
This NOFO will provide up to three years (R61 phase) of support for milestone-driven testing of pharmacokinetics, bioavailability, and assessment of the natural products effect (i.e., measure of mechanism of action) when used by humans on a specified target measure. If milestones in the R61 phase are achieved, up to 3 years of additional support (R33 phase) may be awarded to replicate the impact of the natural product on target engagement(s) when used by humans and assess whether there is an association between the degree of the impact on the target engagement and clinical outcomes in a participant population. Applications are encouraged to design R33 studies to determine how to optimize the impact of the natural product on the target engagement by optimizing the delivery of the natural product through examination of different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to impact the same target engagement measure; or study the impact of the natural product in a population that is more responsive,
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) application form
- Project Narrative/Research Plan
- Budget and Budget Justification
- Biographical Sketches of key personnel
- Letters of Support (if applicable)
- Preliminary Data/Evidence section
- Human Subjects Protection documentation (IRB approval or plan)
- Facilities and Resources description
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.213 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$22,367,527
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$21,646,919
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$19,236,131
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$17,730,528
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$15,036,701
-
$14,473,882
-
$12,748,932
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$11,956,053
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$11,225,697
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$10,919,780
Top States by Funding
- CA 13 awards $83.5M
- MA 13 awards $80.2M
- WA 8 awards $69.9M
- NC 7 awards $53.8M
- NY 6 awards $40.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.213). How funding has trended year over year.
| 2024 | $240,178,154 | |
| 2025 | $232,899,116 | |
| 2026 est. | $2,655,626 |
FAQ
Who can apply for this grant?
Academic institutions, research organizations, faith-based organizations, HBCUs, tribal colleges, and other eligible organizations. Individual investigators must be affiliated with an eligible institution.
What type of natural products are eligible?
Botanicals, probiotics, dietary supplements, and standardized nutritional compounds with strong scientific premise. Products must have compelling preliminary evidence for human efficacy.
How much funding is available?
Awards are up to $350,000 in total. R61 phase funds up to 3 years; R33 phase funds up to 3 additional years if milestones are achieved.
What is the application deadline?
The fixed deadline is November 13, 2026. Check the NIH grants portal for submission windows and time zones.
Must my study include human subjects?
Yes. Trials must be designed to test pharmacokinetics, bioavailability, and mechanism of action in human participants with a specified target outcome.
💡 Tips for applicants
- Build a strong preliminary evidence section showing your natural product has scientific merit and clear target mechanisms worth testing in humans.
- Design R61 milestones with specific, measurable endpoints for pharmacokinetics and mechanism of action assessment to increase transition to R33 funding.
- Include detailed bioavailability data and human dosing rationale based on current literature and any prior safety studies.
- Plan R33 optimization strategies upfront (dose/formulation variants, combination approaches) to show you can maximize clinical impact if initial testing succeeds.
- Engage a clinical trial protocol expert early to ensure your design meets regulatory expectations and generates high-utility data regardless of outcome.
⚠️ Common mistakes
Weak preliminary evidence or vague mechanism of action claims make applications uncompetitive. Proposed studies must have clear scientific rationale and defined target engagement measures.
Unrealistic R61 milestones or poorly operationalized endpoints prevent applicants from successfully transitioning to R33 funding. Milestone failure results in grant termination.
Insufficient attention to human safety, dosing rationale, and regulatory pathway shows lack of preparation for clinical translation. Review FDA guidance on dietary supplements and clinical trial design early.
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