NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)
National Institutes of Health (NIH) · NIH Institute/Center · PAR-25-271
Source: Grants.gov · View original posting ↗
- AwardWhat a single award can be worth — the funder's published per-award amount or floor–ceiling range.
- $350K total
- DeadlineFinal application due date.
- Nov 13, 2026
- Letter of intentDue date for the letter of intent (a short pre-application some funders require or request before the full proposal).
- —
- MechanismNIH activity code — the grant type (R01 research project, R21 exploratory, K series career development, F series fellowship, …).
- R01
- DurationMaximum project period for a single award.
- —
- Expected awardsHow many awards the funder anticipates making under this opportunity.
- —
- Funding cycleHow often the program accepts applications (annual, multiple cycles per year, rolling, or one-time).
- Standard NIH dates
- Open dateWhen applications open (or opened).
- Dec 2, 2024
- Total fundingThe overall pool the funder expects to commit across ALL awards under this opportunity — not what one project receives.
- $350K total
- Clinical trialWhether proposed projects must, may, or must not include a clinical trial.
- Required
Funding context
Based on FY2024 NIH (all institutes) R01 applications (5,385 of 33,139 applications awarded).
Institute-specific data wasn’t available — showing the NIH-wide rate for this mechanism.
Payline: NIH discontinued percentile paylines for 2026 under its Unified Funding Strategy ↗ — scores are now weighed in context rather than against a fixed cutoff.
NIH-wide R01, all institutes.
Aggregate historical data by institute, mechanism, and fiscal year — context for planning, not a prediction for this opportunity. Source ↗
Research areas
Auto-classified from the title and description (keyword-based) — may be imperfect.
Description
This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated mid-phase clinical trials of natural products(i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. All applications submitted under this NOFO must be supported by sufficient preliminary data demonstrating bioavailability (if applicable) and documentation that the natural product produces a reproducible and measurable impact on target engagement (i.e., measure of the mechanism of action). Only in cases when it is not possible/practical to measure target engagement in the patient population of interest or when there is a fundamental understanding of the products mechanism of action will this preliminary data requirement be waived. Applications submitted to this NOFO should propose a mid-phase clinical trial to do the following: determine the optimal dose or formulation of a given natural product for use in a future multi-site efficacy trial; or determine which patient phenotypes will be responders versus non-responders to the natural product to inform inclusion/exclusion criteria of a future efficacy trial. Clinical trials submitted under this NOFO are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This NOFO will not support single-site or multi-site efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer. Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NO
Data notes: administering NIH institute could not be identified from the opportunity number.