NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)
OpenDeadline: Nov 13, 2026federal
Updated: Oct 30, 2025
Summary
The grant aims to support mid-phase clinical trials of natural products, such as botanicals and dietary supplements, that have a strong scientific basis for further testing. Eligible applicants include state and local governments, for-profit and nonprofit organizations, educational institutions, and various tribal organizations. Interested parties should contact the appropriate NCCIH Scientific/Research contact before applying, as detailed application procedures are outlined in the full opportunity announcement.
Full Description
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
Eligibility
Eligible applicants
Government
- State governments
- Special district governments
- City or township governments
- Public and Indian housing authorities
- Federally recognized Native American tribal governments
- County governments
Business
- For-profit organizations other than small businesses
- Small businesses
Nonprofit
- Nonprofits non-higher education with 501(c)(3)
- Nonprofits non-higher education without 501(c)(3)
- Other Native American tribal organizations
Education
- Public and state institutions of higher education
- Private institutions of higher education
- Independent school districts
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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