NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)
OpenDeadline: Nov 13, 2026federal
Updated: Oct 30, 2025
Summary
The purpose of this grant is to support investigator-initiated, early phase clinical trials of natural products, such as botanicals and dietary supplements, that have a strong scientific basis for further testing. Eligible applicants include various nonprofit organizations, educational institutions, government entities, and small businesses, among others. To apply, interested parties should refer to the full opportunity announcement for specific application instructions and details.
Full Description
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
Eligibility
Eligible applicants
Nonprofit
- Other Native American tribal organizations
- Nonprofits non-higher education without 501(c)(3)
- Nonprofits non-higher education with 501(c)(3)
Education
- Private institutions of higher education
- Public and state institutions of higher education
- Independent school districts
Government
- City or township governments
- State governments
- Federally recognized Native American tribal governments
- County governments
- Special district governments
- Public and Indian housing authorities
Business
- Small businesses
- For-profit organizations other than small businesses
Miscellaneous
- Other
Additional information
Other Eligible Applicants include the following:
Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Grantor contact information
Description
NIH Grants Information
grantsinfo@nih.gov
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Apply on official siteUpdated Oct 30, 2025
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