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NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)

Federal funding opportunity PAR-25-271 from National Institutes of Health (Department of Health and Human Services).

Apply on Grants.gov →Application closes November 13, 2026

Posted: December 2, 2024
Closes: November 13, 2026
Program funding: $350,000
Cost sharing: No
Instrument: Grant
Assistance listing: 93.213
Category: Health
Archives: December 19, 2026

Program funding history

Awards made under Assistance Listing 93.213 across FY2024–FY2026, from public federal spending records.

FY2024 obligated: $118.3M
FY2025 obligated: $115.4M
FY2026 (to date) obligated: $53.3M
Awards in window: 697

Top recipients: University of California, San Diego, The General Hospital Corporation, Yale Univ, Regents of the University of California, San Francisco, the, The Spaulding Rehabilitation Hospital Corporation

Source: USAspending.gov · refreshed August 2026

Synopsis

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

For profit organizations other than small businesses
Special district governments
State governments
Independent school districts
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Small businesses
Others (see text field entitled "Additional Information on Eligibility" for clarification)
City or township governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
County governments
Private institutions of higher education
Public and State controlled institutions of higher education
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Native American tribal governments (Federally recognized)

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

Applications go through the official government listing. Grants Radar links you straight to the source — applying is free.

View on Grants.gov Full announcement

Agency contact: National Institutes of Health · [email protected] · 301-402-2541

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