Official funding announcement — preliminary draft
Funder: National Institutes of Health
Opportunity number: PAR-25-271
Official listed status: posted
Closing information: 2026-11-13 (official deadline clock time and time zone must be checked in NOFO)
Award disclosure: Applicant-level ceiling not stated in the retrieved federal synopsis; verify in full NOFO.
Applicant categories in federal synopsis: Others (see text field entitled "Additional Information on Eligibility" for clarification); Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Independent school districts; County governments; City or township governments; Public and State controlled institutions of higher education; Public housing authorities/Indian housing authorities; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Native American tribal governments (Federally recognized); State governments; For profit organizations other than small businesses; Special district governments; Small businesses; Native American tribal organizations (other than Federally recognized tribal governments); Private institutions of higher education
Federal 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 …
Draft intake record. Eligibility, program terms, current amendments and applicant ceiling must be independently verified before publishing.