NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)
Applications close Nov 13, 2026
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- Agency
- National Institutes of Health
- Opportunity number
- PAR-25-271
- Posted
- Dec 2, 2024
- Closes
- Nov 13, 2026
- Estimated program funding
- $350,000
- Cost sharing required
- false
About this opportunity
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
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.
How to apply
- 1Register your organization
Applications are submitted by your institution, not individuals. Make sure your organization has an active SAM.gov registration (with a UEI) and a Grants.gov account with an Authorized Organization Representative.
- 2Read the full notice
Open the official notice for the complete eligibility rules, review criteria, page limits, and required forms. Applications close Nov 13, 2026.
- 3Download the application package
From the Grants.gov opportunity page, download the package (or apply via your agency's system where required) and prepare each component.
- 4Build and submit
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Agency contact: National Institutes of Health · grantsinfo@nih.gov
Details are pulled from Grants.gov and can change, always confirm against the official notice. GrantsManager isn't affiliated with these agencies.
About the NIH R01 program
NIH's flagship, investigator-initiated grant for a discrete, mature research project.
Typical award: Typically 3-5 years. Budgets up to $250K/year in direct costs use the modular format; requests of $500K+/year in direct costs need prior agreement from the institute.
Resources for applying
All NIH grants and resources- Proposal submission checklist
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- NIH eRA Commons
NIH application status, progress reports (RPPR), and award management.
- SciENcv
Biosketches and Current & Pending (Other) Support documents.
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