NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-25-269
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Up to $350,000
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- City/Township Governments
- Higher Education Inst. (Private)
- Other
- 501(c)(3) Nonprofits
- Non-501(c)(3) Nonprofits
- Tribal Organizations (Not Federally Recognized)
- County Governments
- For Profit Organizations
- Special District Governments
- Independent School Districts
- Tribal Governments (Federally Recognized)
- Small Businesses
- State Governments
- Public or Indian Housing Auth.
- Higher Education Inst. (Public)
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health National Center for Complementary and Integrative Health (NCCIH) is soliciting applications for investigator-initiated, early phase clinical trials of natural products (botanicals, probiotics, dietary supplements, and standardized nutritional regimens) with strong scientific premise, with applications due November 13, 2026.
Eligible applicants include state and local governments, higher education institutions (public and private), tribal governments and organizations, nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, small businesses, and special district governments. Non-domestic entities and non-domestic components of U.S. organizations are not eligible.
The award uses a phased R61/R33 mechanism. The R61 phase provides up to three years of support for milestone-driven testing of pharmacokinetics, bioavailability, and assessment of the natural product's effect on a specified target measure in humans. Upon achievement of R61 milestones, applicants may receive up to three additional years of R33 support to replicate the impact on target engagement, assess association with clinical outcomes, and examine optimization strategies including different doses, formulations, combination with other treatments, or study populations more responsive to the intervention.
Trials must be designed to generate high scientific utility whether results are positive or negative. The program encourages R33 applications to optimize natural product delivery and explore combined-treatment approaches targeting the same mechanism.
Evaluation criteria assess scientific merit and innovation, technical adequacy of experimental design, investigator competency, facilities and resources, budget justification, relevance to program objectives, and adequacy of human or animal subject protections. Applications undergo two-stage peer review and compete for available funds based on scientific merit, program relevance, and program balance.
The funding opportunity operates under CFDA 93.213, Research and Training in Complementary and Integrative Health.
Synopsis
This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, probiotics, and products marketed as dietary supplements), 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 three years (R61 phase) of support for milestone-driven testing of pharmacokinetics, bioavailability, and assessment of the natural products effect (i.e., measure of mechanism of action) when used by humans on a specified target measure. If milestones in the R61 phase are achieved, up to 3 years of additional support (R33 phase) may be awarded to replicate the impact of the natural product on target engagement(s) when used by humans and assess whether there is an association between the degree of the impact on the target engagement and clinical outcomes in a participant population. Applications are encouraged to design R33 studies to determine how to optimize the impact of the natural product on the 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 impact the same target engagement measure; or study the impact of the natural product in a population that is more responsive,
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-25-269-Full-Announcement.html | HTML file | |
| PKG00289346.pdf |
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