Simpler Grants.gov #PAR-25-270

NIH Solicitation for Early Phase Clinical Trials of Natural Products

The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), is inviting applications for early phase clinical trials focused on natural products. - Government Buyer: - National Institutes of Health (NIH) - National Center for Complementary and Integrative Health (NCCIH) - Products/Services Requested: - Investigator-initiated clinical trials of natural products, including: - Botanicals - Dietary supplements - Probiotics - Nutritional regimens (e.g., omega-3 fatty acids, anthocyanidins, polyphenols) - Studies must assess target engagement in humans and associations with functional or clinical outcomes - Research may include optimizing delivery, exploring different doses/formulations, combining with other treatments, or focusing on responsive populations - Unique/Notable Requirements: - Efficacy or effectiveness trials are not supported - Wide eligibility: nonprofits, educational institutions, government entities, businesses, tribal and minority-serving organizations - No specific OEMs or vendors are named; focus is on investigator-driven research - Period of Performance: - Up to 3 years of support under the R33 funding mechanism - Place of Performance: - National Institutes of Health (NIH)

Description

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase clinical trials of natural products such as botanicals, dietary supplements, and probiotics with a strong scientific premise for further clinical testing. The trials must be designed to provide scientifically useful results that support decisions about further development or testing of the natural product. The NOFO provides up to 3 years of support to replicate the impact of the natural product on target engagement in humans and assess associations with functional or clinical outcomes. Applications may explore optimizing delivery, combining with other treatments, or studying responsive target populations. Efficacy or effectiveness trials are not supported under this NOFO.

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