Official funding announcement — preliminary draft
Funder: National Institutes of Health
Opportunity number: PAR-25-269
Official listed status: posted
Closing information: 2026-11-13 (official deadline clock time and time zone must be checked in NOFO)
Award disclosure: Official federal synopsis lists an award ceiling of 350,000; applicant-level applicability requires full-NOFO review.
Applicant categories in federal synopsis: Independent school districts; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Special district governments; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; City or township governments; For profit organizations other than small businesses; Public and State controlled institutions of higher education; Native American tribal governments (Federally recognized); Others (see text field entitled "Additional Information on Eligibility" for clarification); County governments; Private institutions of higher education; State governments; Native American tribal organizations (other than Federally recognized tribal governments); Public housing authorities/Indian housing authorities; Small businesses
Federal 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 …
Draft intake record. Eligibility, program terms, current amendments and applicant ceiling must be independently verified before publishing.