Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Oct 19, 2026
Can you apply?
This grant is for mid-phase clinical trials testing natural products like botanicals and dietary supplements. Eligible applicants include research institutions, colleges, universities, tribal organizations, and faith-based organizations. Trials must have strong preliminary scientific evidence and measure bioavailability or target engagement. Applications cannot be for cancer treatment/prevention, single-site efficacy trials, or multi-site effectiveness trials.
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Program description
This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated mid-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. All applications submitted under this NOFO must be supported by sufficient preliminary data demonstrating bioavailability (if applicable) and documentation that the natural product produces a reproducible and measurable impact on target engagement (i.e., measure of the mechanism of action). Only in cases when it is not possible/practical to measure target engagement in the patient population of interest or when there is a fundamental understanding of the products mechanism of action will this preliminary data requirement be waived.
Applications submitted to this NOFO should propose a mid-phase clinical trial to do the following: determine the optimal dose or formulation of a given natural product for use in a future multi-site efficacy trial; or determine which patient phenotypes will be responders versus non-responders to the natural product to inform inclusion/exclusion criteria of a future efficacy trial. 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 NOFO will not support single-site or multi-site efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer.
Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NO
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) Application Form
- Project Narrative
- Budget and Budget Justification
- Biographical Sketches (NIH Form 5 pages max)
- Other Support documentation
- Preliminary data and evidence on natural product bioavailability and target engagement
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
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$19,236,131
-
$17,730,528
-
$16,441,407
-
$14,473,882
-
$14,460,130
-
$12,748,932
-
$11,956,053
-
$11,225,697
Top States by Funding
- MA 14 awards $86.2M
- CA 13 awards $83.9M
- WA 8 awards $69.9M
- NY 9 awards $62.1M
- NC 7 awards $53.8M
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?
Research institutions, HBCUs, Hispanic-serving institutions, tribal colleges, and faith-based organizations can apply. Non-domestic entities and non-U.S. components of U.S. organizations are not eligible.
What types of natural products are included?
Botanicals, dietary supplements, probiotics, and standardized nutritional compounds with strong preliminary evidence. Omega-3 fatty acids, anthocyanidins, and polyphenols are examples.
What stage of research does this fund?
Mid-phase clinical trials that determine optimal dosage, formulation, or identify responder phenotypes. It does not fund efficacy trials or cancer research.
What preliminary data is required?
Applicants must document bioavailability (if applicable) and show the product produces measurable impact on target engagement. This requirement may be waived if target engagement cannot be measured.
What is the deadline?
The deadline is November 13, 2026. Contact NCCIH scientific staff before submitting your application.
💡 Tips for applicants
- Contact your NCCIH scientific officer before writing to ensure alignment with research priorities and mission.
- Build strong preliminary data demonstrating bioavailability and target engagement in your specific population.
- Frame your trial as hypothesis-driven and milestone-based, not as an efficacy study.
- Clearly specify whether your trial determines optimal dose/formulation or identifies responder phenotypes.
- Ensure your natural product has standardized composition and compelling preliminary evidence of effect.
⚠️ Common mistakes
Weak or insufficient preliminary data on bioavailability and target engagement. Proposing efficacy trials, multi-site effectiveness studies, or cancer-related research. Failing to align project with NCCIH's research priorities and mission.
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