Simpler Grants.gov #PAR-25-271

NIH Solicitation for Mid-Phase Clinical Trials of Natural Products (R01 Clinical Trial Required)

The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), is inviting applications for mid-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 mid-phase clinical trials focused on natural products - Eligible products: botanicals, dietary supplements, probiotics, nutritional regimens (e.g., omega-3 fatty acids, anthocyanidins, polyphenols) - Required: preliminary data on bioavailability and measurable target engagement, unless justified otherwise - Focus: determining optimal dosing/formulation and identifying patient phenotypes for future multi-site efficacy trials - Unique/Notable Requirements: - Excludes efficacy/effectiveness trials and cancer-related trials - Applicants must provide evidence of product standardization and impact on biological targets - Open to a wide range of applicant types, including government, business, nonprofit, and educational entities - No specific OEMs or vendors are named, as this is a research funding opportunity rather than a product procurement - Funding Opportunity Number: PAR-25-271 - Total funding amount: $350,000

Description

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated mid-phase clinical trials of natural products, including botanicals, dietary supplements, and probiotics, with a strong scientific premise for further clinical testing. The trials should determine the optimal dose or formulation and identify patient phenotypes that respond to the natural product. Applications must be supported by preliminary data demonstrating bioavailability and target engagement, except in specific cases where this is not feasible. The NOFO excludes efficacy or effectiveness trials and trials testing natural products for cancer treatment or prevention.

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