NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)
Funding for early phase clinical trials of natural products, including botanicals and dietary supplements, to assess impact on target engagement and patient outcomes.
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 $1,050,000 in direct costs over 3 years per award; project period not to exceed 3 years.
Summary: Supports early phase clinical trials of natural products (botanicals, dietary supplements, probiotics, standardized nutritional regimens) to replicate target engagement and assess association with clinical outcomes in humans.
Key Information: Efficacy/effectiveness trials and cancer prevention/treatment studies are not supported; strong preliminary data on target engagement in humans is required.
Description
This opportunity, offered by the National Center for Complementary and Integrative Health (NCCIH) at NIH, funds investigator-initiated, early phase clinical trials of natural products. Eligible natural products include botanicals, dietary supplements, probiotics, and standardized nutritional regimens (e.g., omega-3 fatty acids, polyphenols) with compelling preliminary evidence and a strong scientific premise for further clinical testing.
The primary goal is to support studies that:
- Replicate the impact of the natural product on a well-defined biological target ("target engagement") in humans.
- Assess whether changes in target engagement are associated with functional or clinical outcomes in a patient population.
Trials must be hypothesis-driven, milestone-based, and designed so that results—positive or negative—will inform decisions about further development or testing of the natural product. The mechanism (R33) is intended to accelerate translation of basic science findings into early-stage clinical testing.
Note: This opportunity does not support efficacy or effectiveness trials, nor trials for cancer prevention or treatment.
