NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-25-271
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- State Governments
- For Profit Organizations
- 501(c)(3) Nonprofits
- Small Businesses
- Higher Education Inst. (Public)
- Special District Governments
- Higher Education Inst. (Private)
- Non-501(c)(3) Nonprofits
- Tribal Organizations (Not Federally Recognized)
- City/Township Governments
- Other
- Public or Indian Housing Auth.
- Tribal Governments (Federally Recognized)
- County Governments
- Independent School Districts
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Center for Complementary and Integrative Health (NCCIH) is soliciting applications for investigator-initiated mid-phase clinical trials of natural products with application deadline November 13, 2026 under CFDA 93.213. Trials must test botanicals, dietary supplements, probiotics, or standardized nutritional regimens supported by sufficient preliminary data demonstrating bioavailability and reproducible, measurable target engagement; this requirement may be waived only when measuring target engagement is not practical in the patient population or when the product's mechanism of action is fundamentally understood. Applications proposing single-site or multi-site efficacy trials, or trials testing natural products for cancer treatment or prevention, are not eligible.
Eligible applicants include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, small businesses, tribal organizations, state and local governments, and special district governments. Foreign organizations and non-domestic components of U.S. organizations are not eligible.
Mid-phase trials must pursue one of two objectives: determine optimal dose or formulation of a natural product for use in a future multi-site efficacy trial, or identify which patient phenotypes will be responders versus non-responders to inform inclusion and exclusion criteria for future efficacy trials. Trials must be hypothesis-driven, milestone-driven, and directly aligned with NCCIH research priorities and mission. Applicants are encouraged to contact NCCIH scientific staff in their area before submission.
Awards undergo two-stage peer review with evaluation based on scientific merit, technical adequacy, investigator competency, facility adequacy, budget necessity, program relevance, and human subject protections. Average award timelines span six to ten months from application to notice of award.
Synopsis
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
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.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-271-Full-Announcement.html | HTML file | |
| PKG00289348.pdf |
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