The National Institutes of Health (NIH) is offering the NCCIH Natural Product Early Phase Clinical Trial Award (R33), aimed at supporting investigator-initiated clinical trials of natural products such as botanicals and dietary supplements. This funding opportunity encourages applications for early phase trials that assess the impact of these products on specific biological targets and their potential clinical outcomes, with a focus on optimizing study designs and dosage. The initiative is crucial for advancing research in complementary and integrative health approaches, ensuring that projects adhere to rigorous scientific standards and include a Plan for Enhancing Diverse Perspectives (PEDP). The total estimated funding for this program is $1,050,000, with applications due by November 13, 2026. For further inquiries, interested applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information page at https://grants.nih.gov/grants/guide/pa-files/PAR-25-270.html.

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The National Institutes of Health (NIH) is issuing a funding opportunity through the NCCIH Natural Product Early Phase Clinical Trial Award (R33) to support investigator-initiated trials of natural products like botanicals and dietary supplements with strong scientific foundations. The R33 mechanism is designed for early phase clinical trials, focusing on replicating the impact of these natural products on specific biological targets and their potential clinical effects over a maximum of three years. The funding aims to assess various study designs, dosage optimization, and the combination of these products with other therapies. Projects must comply with rigorous methodological standards and demonstrate a clear rationale through preliminary data. A key requirement is the inclusion of a Plan for Enhancing Diverse Perspectives (PEDP) to promote inclusivity and collaboration in research efforts. The document outlines specific details about eligibility, application processes, and review criteria, while emphasizing the importance of rigorous scientific inquiry in advancing complementary and integrative health approaches.

https://grants.nih.gov/grants/guide/pa-files/PAR-25-270.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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