NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)
NIH (NCCIH) R01 funding for mid-phase clinical trials of natural products such as botanicals, dietary supplements, and probiotics that already have strong preliminary data. Intended for research in…
- Deadline
- Nov 13, 2026
- Posted
- Dec 2, 2024
- Award amount
- Amount not specified
- Focus areas
- Health
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We’ll email you before Nov 13, 2026 so you have time to apply.
In plain English
NIH (NCCIH) R01 funding for mid-phase clinical trials of natural products such as botanicals, dietary supplements, and probiotics that already have strong preliminary data. Intended for research institutions able to conduct hypothesis-driven, milestone-based clinical trials; foreign organizations are not eligible. No dollar amount is stated. It will not support efficacy/effectiveness trials or cancer-treatment trials, and requires substantial prior preliminary data, so it is narrow in scope.
AI-generated summary to help you decide quickly — verify the official eligibility rules before applying.
Who can apply
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
About this grant
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
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