The NCCIH is offering its Phased Innovation Award (R61/R33) to support investigator-initiated, early phase clinical trials of natural products. This grant encourages testing of botanicals, probiotics, dietary supplements, and specific nutritional compounds with strong preliminary evidence. The trials must generate high scientific utility to guide future development. The R61 phase (up to three years) focuses on pharmacokinetics, bioavailability, and mechanism of action in humans. Successful R61 projects may receive R33 support (up to three additional years) to replicate target engagement, assess its association with clinical outcomes, and explore optimized delivery methods or combinations with other treatments, or study in responsive populations. This grant aims to advance promising natural products through rigorous clinical testing.
Opportunity ID: 357490
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-269 |
| Funding Opportunity Title: | NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/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: | $350,000 |
| Award Ceiling: | $350,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments 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) Native American tribal organizations (other than Federally recognized tribal governments) Small businesses State governments City or township governments Private institutions of higher education Public and State controlled institutions of higher education For profit organizations other than small businesses |
| 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, probiotics, and products marketed as dietary supplements), 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 three years (R61 phase) of support for milestone-driven testing of pharmacokinetics, bioavailability, and assessment of the natural products effect (i.e., measure of mechanism of action) when used by humans on a specified target measure. If milestones in the R61 phase are achieved, up to 3 years of additional support (R33 phase) may be awarded to replicate the impact of the natural product on target engagement(s) when used by humans and assess whether there is an association between the degree of the impact on the target engagement and clinical outcomes in a participant population. Applications are encouraged to design R33 studies to determine how to optimize the impact of the natural product on the 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 impact the same target engagement measure; or study the impact of the natural product in a population that is more responsive, |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-269.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 357490 Full Announcement-PAR-25-269 -> PAR-25-269-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 | PKG00289346 | May 23, 2025 | Nov 13, 2026 | View |
Package 1
Mandatory forms
357490 RR_SF424_5_0-5.0.pdf
357490 PHS398_CoverPageSupplement_5_0-5.0.pdf
357490 RR_OtherProjectInfo_1_4-1.4.pdf
357490 PerformanceSite_4_0-4.0.pdf
357490 RR_KeyPersonExpanded_4_0-4.0.pdf
357490 RR_Budget10_3_0-3.0.pdf
357490 PHS398_ResearchPlan_5_0-5.0.pdf
357490 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357490 RR_SubawardBudget10_30_3_0-3.0.pdf
357490 PHS_AssignmentRequestForm_4_0-4.0.pdf
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