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Simpler Grants

No. PAR-25-271 · National Institutes of Health

Open

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

grants.gov listing Full announcement (NOFO)
Dealbreakers No cost share required Audit: not stated
Not reimbursement-only
“Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.” — From the announcement
Award range
Not specified
Expected awards
Not specified
Application deadline
Nov 13, 2026
Posted
Dec 2, 2024
Last verified
Today

At a glance

AI summary

This program funds mid-phase clinical trials of natural products, including botanicals, probiotics, dietary supplements, and standardized nutritional regimens, to improve evidence about dosing, participant characteristics, target engagement, and study methods. Applicants may include higher education institutions, nonprofits, for-profit organizations, governments, tribal entities, faith-based or community-based organizations, regional organizations, and foreign organizations are not eligible to apply. Awards are grants; the number of awards depends on NIH appropriations and the number of meritorious applications, and budgets are not limited, though requests above $350,000 per year in direct costs are not recommended. The project period is recommended to be no more than three years, with a maximum of five years, and there is no cost-share requirement stated. Applications must involve a clinical trial and may not propose waitlist controls, phase I studies, cancer prevention or treatment trials, or non-domestic entities as applicants.

AI-generated summary — verify against the announcement

What it funds

  • Health
  • Research & Discovery
  • Patients & People with Health Conditions
  • Researchers & Scholars
  • Biomedical & Disease Research
Official description from grants.gov

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

  • City or township governments
  • County governments
  • For-profit organizations other than small businesses
  • Independent school districts
  • Native American tribal governments (Federally recognized)
  • Native American tribal organizations (other than Federally recognized)
  • Nonprofits with 501(c)(3) status (other than higher education)
  • Nonprofits without 501(c)(3) status (other than higher education)
  • Others
  • Private institutions of higher education
  • Public and State controlled institutions of higher education
  • Public housing authorities / Indian housing authorities
  • Small businesses
  • Special district governments
  • State governments
Geographic restriction None found in the announcement — likely nationwide

Program history

USASpending.gov

Assistance listing 93.213 · Research and Training in Complementary and Integrative Health

Real awards this federal program has made — the whole assistance listing (93.213), not just this notice.

Fiscal year Awards Median award Middle half
FY 2026 (so far) 58 $441,813 $190,230 – $676,906
FY 2025 51 $472,500 $321,065 – $1,329,943
FY 2024 100 $562,397 $286,558 – $1,285,052
FY 2023 92 $695,557 $380,313 – $1,709,004
FY 2022 94 $715,153 $419,983 – $1,985,928
FY 2021 92 $1,686,420 $625,217 – $3,082,386
Who wins it Higher education (342), Nonprofit (97), Business (33) of 487 awards — categories can overlap.
Top states CA (77) · MA (59) · NY (29) · NC (12) · IL (11)
Largest recent awards
  1. REGENTS OF THE UNIVERSITY OF MINNESOTA $21,646,919 · FY 2022
  2. UNIVERSITY OF FLORIDA $11,192,369 · FY 2022
  3. DUKE UNIVERSITY $7,025,837 · FY 2022
  4. THE RAND CORPORATION $6,237,409 · FY 2023
  5. THE SPAULDING REHABILITATION HOSPITAL CORPORATION $5,991,655 · FY 2023

Source: USASpending.gov · refreshed Aug 21, 2026