Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Sep 4, 2026
Can you apply?
This grant is for investigators at universities, research institutions, and eligible organizations conducting early-phase clinical trials of natural products. Applicants must have preliminary evidence showing the natural product has promise for further clinical testing. Eligible organizations include HBCUs, HSIs, tribal colleges, faith-based organizations, and federal agencies. Domestic U.S. institutions are preferred; non-U.S. components of U.S. organizations are not eligible.
Trials must be hypothesis-driven and directly aligned with NCCIH's research priorities. Studies should test how natural products engage biological targets and assess links to clinical outcomes. Duration is typically up to 3 years of support.
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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, dietary supplements, and probiotics), 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 3 years support for studies to replicate the impact of the natural product on target engagement when used by humans, and assess whether there is an association between the degree of the impact on target engagement and functional or clinical outcomes in a patient population. Applications are encouraged to design studies to determine how to optimize the impact of the natural product on 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 engage the same target; or study the impact of the natural product in a target population that is more responsive. Clinical trials submitted under this NOFO are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early-stage clinical testing to determine whether continued clinical research is warranted. This NOFO will not support efficacy or effectiveness trials, nor will
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Faith-based Organization
- HBCU
- HSI (Hispanic Serving Institution)
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Researcher (independent)
- Small Business (SBA-defined)
- Special District
- State Government
- TCU (Tribal Colleges)
- Tribal Nation
- Tribal Organization
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R)
- Project Narrative/Research Plan
- Budget and Budget Justification
- Biosketch(es) for key personnel
- Institutional biosafety or IBC approval (if applicable)
- Letters of support/commitment
- Preliminary data/prior publications
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
-
$22,367,527
-
$21,646,919
-
$19,236,131
-
$17,730,528
-
$15,036,701
-
$14,473,882
-
$12,748,932
-
$11,956,053
-
$11,225,697
-
$10,919,780
Top States by Funding
- CA 13 awards $83.9M
- MA 13 awards $81.4M
- WA 8 awards $69.9M
- NC 7 awards $53.8M
- NY 8 awards $47.7M
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
What types of natural products are eligible for this grant?
Botanicals, dietary supplements, probiotics, and standardized nutritional regimens with strong preliminary evidence. Examples include omega-3 fatty acids and polyphenol-rich compounds.
Can I apply if my institution is not a research university?
Yes, eligible applicants include HBCUs, HSIs, tribal colleges, faith-based organizations, and community-based organizations. Federal agencies and regional organizations are also eligible.
What is the typical project length?
Projects typically receive up to 3 years of support. Studies must be milestone-driven with clear targets for target engagement assessment.
Will this fund efficacy or effectiveness trials?
No. This grant supports early-phase clinical trials designed to gather preliminary data, not full efficacy or large-scale effectiveness studies.
When is the deadline?
The deadline is November 13, 2026. Check the NIH website for any updates or reissuance of this NOFO.
💡 Tips for applicants
- Build your application on strong preliminary data. NCCIH prioritizes studies with compelling evidence the natural product warrants clinical testing.
- Design studies to measure target engagement clearly. Document how the product affects the biological pathway you're studying.
- Include milestones for Go/No-Go decisions. Show how interim results will drive decisions about continuing the research.
- Address how you'll optimize the intervention. Propose dose/formulation optimization or combination approaches to maximize target engagement.
- Align your research to NCCIH priorities. Review NCCIH's strategic plan and explain how your trial fits their mission in natural product research.
⚠️ Common mistakes
Submitting without sufficient preliminary data showing the natural product's promise. Proposing a full efficacy or effectiveness trial rather than an early-phase proof-of-concept study. Failing to articulate clear hypotheses about target engagement and clinical relevance.
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