Simpler Grants.gov #PAR-25-269

NIH Solicitation for Early Phase Clinical Trials of Natural Products (NCCIH R61/R33)

The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), is inviting applications for early phase clinical trials of 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, probiotics, dietary supplements, and nutritional regimens - Focus on standardized compounds such as omega-3 fatty acids, anthocyanidins, and polyphenols - Milestone-driven research on pharmacokinetics, bioavailability, mechanism of action, and clinical outcomes in humans - Unique/Notable Requirements: - Phased innovation award structure: up to three years for initial testing (R61 phase), with potential for an additional three years for replication and outcome assessment (R33 phase) - Applicants may propose optimization of delivery, combination therapies, or studies in responsive populations - No specific OEMs or vendors are named; applicants propose their own products and regimens - Minimum grant award is $350,000 - Broad eligibility: government, educational, nonprofit, business, tribal, and minority-serving institutions - 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, probiotics, and dietary supplements with a strong scientific premise. The trials must be designed to provide high scientific utility information to support further development or testing of the natural product. The NOFO provides up to three years of support for milestone-driven testing of pharmacokinetics, bioavailability, and mechanism of action in humans (R61 phase), with potential additional support for up to three years to replicate impact and assess clinical outcomes (R33 phase). Applications may also explore optimizing delivery, combining treatments, or studying responsive populations.

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