NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)
This grant supports mid-phase clinical trials of promising natural products for determining optimal doses/formulations or patient responses, excluding cancer trials.
Funder: National Institutes of Health
Due Dates: June 23, 2025 (New, Renewal, Resubmission, Revision) | July 17, 2025 (AIDS) | February 23, 2026 | March 17, 2026 (AIDS) | October 20, 2026 | November 13, 2026 (AIDS)
Funding Amounts: Recommended maximum: $350,000/year direct costs (not a hard cap); up to 3 years recommended, 5 years max; budgets and durations above these require strong justification.
Summary: Supports investigator-initiated mid-phase clinical trials of natural products (botanicals, dietary supplements, probiotics, or standardized nutritional regimens) to determine optimal dosing/formulation or identify responder phenotypes, excluding cancer trials.
Key Information: Preliminary data on bioavailability and target engagement required; efficacy/effectiveness trials and cancer-related studies are not eligible; contact NCCIH program staff before applying, especially for budgets over $500,000/year.
Description
This opportunity from the National Center for Complementary and Integrative Health (NCCIH) at NIH supports investigator-initiated, mid-phase (R01) clinical trials of natural products. The focus is on botanicals, dietary supplements, probiotics, and standardized nutritional regimens with compelling preliminary evidence and a strong scientific premise for further clinical testing.
The goal is to generate data that will inform the design of future multi-site efficacy trials, specifically by:
- Determining the optimal dose or formulation of a natural product.
- Identifying patient phenotypes likely to respond (or not respond) to the intervention, to refine inclusion/exclusion criteria for future studies.
Trials must be hypothesis-driven, milestone-based, and directly aligned with NCCIH research priorities. This program does not support efficacy/effectiveness trials, single-site or multi-site efficacy studies, or trials for cancer treatment or prevention.
