This NCCIH grant is for investigator-initiated, early-phase clinical trials focused on natural products, including botanicals, dietary supplements, probiotics, and specific nutritional compounds. The aim is to replicate the natural product’s impact on target engagement in humans and assess its association with functional or clinical outcomes. Applications are encouraged to optimize product delivery through dose and formulation studies, combine treatments, or identify more responsive target populations. These trials must be hypothesis-based, milestone-driven, and align with NCCIH’s research priorities, accelerating the translation of basic science findings into initial clinical testing to determine if further development is warranted. This R33 mechanism specifically supports early-stage research and does not fund efficacy or effectiveness trials.
Opportunity ID: 357492
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-270 |
| Funding Opportunity Title: | NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 02, 2024 |
| Last Updated Date: | Dec 02, 2024 |
| Original Closing Date for Applications: | Nov 13, 2026 |
| Current Closing Date for Applications: | Nov 13, 2026 |
| Archive Date: | Dec 19, 2026 |
| Estimated Total Program Funding: | $1,050,000 |
| Award Ceiling: | $1,050,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments State governments Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Small businesses Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early 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. Under this NOFO, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This NOFO will provide up to 3 years support for studies to replicate the impact of the natural product on target engagement when used by humans, and assess whether there is an association between the degree of the impact on target engagement and functional or clinical outcomes in a patient population. Applications are encouraged to design studies to determine how to optimize the impact of the natural product on target engagement by optimizing the delivery of the natural product through examination of different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to engage the same target; or study the impact of the natural product in a target population that is more responsive. 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 R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early-stage clinical testing to determine whether continued clinical research is warranted. This NOFO will not support efficacy or effectiveness trials, nor will |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-270.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 357492 Full Announcement-PAR-25-270 -> PAR-25-270-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289347 | May 23, 2025 | Nov 13, 2026 | View |
Package 1
Mandatory forms
357492 RR_SF424_5_0-5.0.pdf
357492 PHS398_CoverPageSupplement_5_0-5.0.pdf
357492 RR_OtherProjectInfo_1_4-1.4.pdf
357492 PerformanceSite_4_0-4.0.pdf
357492 RR_KeyPersonExpanded_4_0-4.0.pdf
357492 RR_Budget_3_0-3.0.pdf
357492 PHS398_ResearchPlan_5_0-5.0.pdf
357492 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357492 RR_SubawardBudget30_3_0-3.0.pdf
357492 PHS_AssignmentRequestForm_4_0-4.0.pdf
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