The National Institutes of Health (NIH) is offering the Natural Product Early Phase Clinical Trial Award (R33), aimed at funding early-phase clinical trials for promising natural products, including botanicals and dietary supplements. This funding opportunity encourages applications that assess target engagement and the relationship between the intervention and clinical outcomes over a maximum period of three years, with total funding not exceeding $1,050,000. The program emphasizes the importance of rigorous and reproducible trials, particularly in managing conditions such as pain and mental health disorders, while requiring a Plan for Enhancing Diverse Perspectives (PEDP) to ensure inclusivity in research. Interested applicants must submit their proposals by November 14, 2026, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.

PAR-24-116-Full-Announcement.html

PAR-24-116.html

The National Center for Complementary and Integrative Health (NCCIH) is offering the Natural Product Early Phase Clinical Trial Award (R33), aimed at funding early-phase clinical trials for promising natural products such as botanicals and dietary supplements. This funding opportunity encourages applications focused on trials that assess target engagement and the relationship between the intervention and clinical outcomes over a maximum period of three years, with total funding not exceeding $1,050,000. Key areas of interest include the management of conditions such as pain and mental health disorders. Applicants must adhere to strict regulatory guidelines and demonstrate adequate preliminary data to support their studies. A Plan for Enhancing Diverse Perspectives (PEDP) is also mandatory, ensuring diverse stakeholder engagement and inclusivity in the research approach. The program prioritizes rigor and reproducibility in trials, and only those that do not seek to assess efficacy or treatment of cancer will be considered. The deadline for application submissions is set for November 14, 2026, with multiple review cycles planned before the award decisions.

https://grants.nih.gov/grants/guide/pa-files/PAR-24-116.html

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics), 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 3 years support for studies to replicate the impact of the natural product on target engagement when used by humans, and assess whether there is an association between the degree of the impact on target engagement and functional or clinical outcomes in a patient population. Applications are encouraged to design studies to determine how to optimize the impact of the natural product on 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 engage the same target; or study the impact of the natural product in a target population that is more responsive. Clinical trials submitted under this NOFO are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early-stage clinical testing to determine whether continued clinical research is warranted. This NOFO will not support efficacy or effectiveness trials, nor will

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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