NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)
National Institutes of Health
Award ceiling
—Award floor
—Posted
Dec 2, 2024Closes
Nov 13, 2026Location eligibility
No specific state restriction found in this listing — check the full opportunity for details.Categories: Health
Eligible applicants: For profit organizations other than small businesses, Public housing authorities/Indian housing authorities, City or township governments, Independent school districts, Private institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, County governments, Public and State controlled institutions of higher education, Small businesses, State governments, Others (see text field entitled "Additional Information on Eligibility" for clarification), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Native American tribal organizations (other than Federally recognized tribal governments), Special district governments, Native American tribal governments (Federally recognized)
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,