NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)
Agency: National Institutes of Health
Assistance Listings: 93.213 -- Research and Training in Complementary and Integrative Health
Last Updated: December 2, 2024
Description
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
Eligible applicants
Government
- City or township governments
- County governments
- Special district governments
- Federally recognized Native American tribal governments
- State governments
- Public and Indian housing authorities
Education
- Private institutions of higher education
- Independent school districts
- Public and state institutions of higher education
Miscellaneous
- Other
Nonprofit
- Nonprofits non-higher education with 501(c)(3)
- Nonprofits non-higher education without 501(c)(3)
- Other Native American tribal organizations
Business
- For-profit organizations other than small businesses
- Small businesses
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.
Documents
| File name | Description | Last updated |
|---|---|---|
| PAR-25-269-Full-Announcement.html | PAR-25-269 Full Announcement Text | Dec 2, 2024 10:00 PM UTC |
Link to additional information
https://grants.nih.gov/grants/guide/pa-files/PAR-25-269.html
Closing: November 13, 2026
Award
$350,000
Program Funding
--
Expected awards
$--
Award Minimum
$350,000
Award Maximum
Funding opportunity number:
PAR-25-269
Cost sharing or matching requirement:
No
Funding instrument type:
Grant
Opportunity Category:
Discretionary
Opportunity Category Explanation:
--
Category of Funding Activity:
Health
Category Explanation:
--
History
Version:
1
Posted date:
December 2, 2024
Archive date:
December 19, 2026
