NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)
This grant funds early phase clinical trials testing natural products like botanicals, probiotics, and dietary supplements with strong scientific backing for further testing.
Funder: National Institutes of Health
Due Dates: May 24, 2025 (Letter of Intent) | June 23, 2025 (New/Renewal/Resubmission/Revision) | July 17, 2025 (AIDS) | Feb 23, 2026 | Mar 17, 2026 (AIDS) | Oct 20, 2026 | Nov 13, 2026 (AIDS)
Funding Amounts: Up to $350,000 direct costs/year (R61 and R33 phases); max 5 years total (up to 3 years per phase)
Summary: Supports early phase, milestone-driven clinical trials of natural products (botanicals, probiotics, dietary supplements, standardized nutritional regimens) to assess pharmacokinetics, target engagement, and links to clinical outcomes.
Key Information: Only U.S.-based organizations may apply; foreign organizations are not eligible, but foreign components are allowed.
Description
This opportunity from the National Center for Complementary and Integrative Health (NCCIH) at NIH funds investigator-initiated, early phase clinical trials of natural products—including botanicals, probiotics, dietary supplements, and standardized nutritional regimens. The program uses a two-phase (R61/R33) mechanism to support milestone-driven research that first establishes pharmacokinetics, bioavailability, and target engagement in humans (R61), and, if milestones are met, transitions to studies that replicate target engagement and assess its association with clinical outcomes (R33). The goal is to generate high-utility data to inform decisions about further development or testing of the natural product.
Trials must be hypothesis-driven, use rigorous methodology, and be directly relevant to NCCIH’s research priorities. This program does not support efficacy or effectiveness trials, nor trials for cancer treatment or prevention.
