The National Institutes of Health (NIH) is offering a funding opportunity through the NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33), aimed at supporting investigator-initiated clinical trials focused on natural products such as botanicals and dietary supplements. This initiative seeks to encourage research that demonstrates a strong scientific premise for further testing, with the R61 phase providing up to three years of funding for milestone-driven studies assessing pharmacokinetics, bioavailability, and the effects of these products on specific target mechanisms. Successful projects may receive an additional three years of funding in the R33 phase to evaluate clinical outcomes related to target engagement. Interested applicants can submit proposals starting February 4, 2024, with a maximum project duration of five years, and should include a Plan for Enhancing Diverse Perspectives (PEDP) as part of their application. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov, and the award ceiling is set at $350,000.

PAR-24-124-Full-Announcement.html

PAR-24-124.html

The National Center for Complementary and Integrative Health (NCCIH) of the Department of Health and Human Services has issued a Notice of Funding Opportunity (NOFO) for the NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33). This initiative supports investigator-initiated clinical trials focusing on natural products—such as botanicals and dietary supplements—with strong scientific backing for further testing. The R61 phase provides up to three years of funding to assess pharmacokinetics, bioavailability, and the product's effects on target mechanisms through milestone-driven studies. If successful, the R33 phase may receive additional funding for up to three more years to further evaluate clinical outcomes related to target engagement. The application process requires adherence to specific guidelines, including submitting a Plan for Enhancing Diverse Perspectives (PEDP), and proposals that do not include this plan will be considered incomplete. Overall, this funding opportunity aims to foster early-stage clinical testing of natural products, accelerating the translation of scientific findings into practical applications, while prioritizing inclusiveness and adherence to regulatory standards. Applications can be submitted beginning February 4, 2024, with a maximum project duration of five years.

https://grants.nih.gov/grants/guide/pa-files/PAR-24-124.html

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,

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

NIH Grants Information&lt;br/&gt;grantsinfo@nih.gov

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