NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)
ID: 357493Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/357493

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-271.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a Notice of Funding Opportunity (NOFO) titled "NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)" aimed at supporting mid-phase clinical trials of natural products, including botanicals, dietary supplements, and probiotics, that demonstrate promising preliminary evidence for health benefits. Applicants are required to provide sufficient preliminary data, adhere to FDA regulations, and develop a Plan for Enhancing Diverse Perspectives (PEDP) to foster inclusivity in research, with a focus on determining optimal dosing and patient responsiveness before advancing to larger efficacy trials. This funding opportunity is critical for addressing knowledge gaps in complementary health approaches, particularly in symptom management and health disparities. The estimated total program funding is $350,000, with applications due by November 13, 2026, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-271-Full-Announcement.html
    PAR-25-271.html
    The Department of Health and Human Services, through the National Center for Complementary and Integrative Health (NCCIH), has issued a Notice of Funding Opportunity (NOFO) titled "NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)." This funding aims to support mid-phase clinical trials on natural products, including botanicals, dietary supplements, and probiotics, which show promising preliminary evidence for health benefits. The objective is to gather robust data on the optimal dosing and target engagement of these products before advancing to larger efficacy trials. Key requirements for applicants include providing sufficient preliminary data, adherence to FDA regulations, and developing a Plan for Enhancing Diverse Perspectives (PEDP) to encourage inclusivity in research. Applications must propose randomized controlled trials with strong scientific justification and are limited to specific types of studies. Funding decisions will prioritize research that addresses knowledge gaps in complementary health approaches, particularly in symptom management and health disparities. The application process includes detailed guidelines, registration requirements, and a streamlined submission through Grants.gov. The deadline for applications is set for 5:00 PM local time of the applicant organization, with ongoing reviews and programmatic priorities outlined by NCCIH.
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