Grant Details

General Overview

Grant Information

Grant name: NCCIH Natural Product Early Phase Clinical Trial Award (R33)

Funding organization: National Institutes of Health (NIH)

Total funding amount: Up to $1,050,000 in direct costs

Duration: Up to 3 years

Primary objective: Support early phase clinical trials of natural products with a strong scientific premise.

Key stakeholders: Researchers, healthcare providers, patients.

Funding source: Federal government (NIH).

Funding type: Grant.

Significance: Addresses the need for rigorous investigation of natural products in clinical settings.

Grant frequency: One-time funding opportunity.

Organizational Aspects

Eligible Organization Types

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

Nonprofits (with and without 501(c)(3) status)

For-Profit Organizations

Small Businesses

Local, State, County, City Governments

Indian/Native American Tribal Governments (Federally Recognized and Other)

Federal Government Agencies

Independent School Districts

Public Housing Authorities

Faith-based or Community-based Organizations

Regional Organizations

Ineligible Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic components of U.S. Organizations are not eligible to apply.

Scope and Focus

Primary Focus Areas

Natural products including botanicals, dietary supplements, and probiotics.

Studies must demonstrate a strong scientific premise for further clinical testing.

Exclusions

Efficacy or effectiveness trials.

Trials testing natural products for the treatment or prevention of cancer.

Technical Details

Technical Expertise Requirements

Investigators must have experience in leading clinical trials.

A multidisciplinary team is encouraged.

Financial Structure

Budget and Funding

Maximum grant amount: $1,050,000 in direct costs.

No cost-sharing is required.

Timeline and Implementation

Key Dates

Open Date: May 23, 2025

Application Due Dates: Various dates until October 20, 2026

Expiration Date: November 14, 2026

Compliance and Requirements

Regulatory Compliance

Must adhere to FDA regulations for clinical research.

Investigators must contact the FDA to determine if an IND application is necessary.

Application Process

Required Documentation

Applications must follow the instructions in the Research Instructions in the How to Apply - Application Guide.

A letter of intent is encouraged but not required.

Special Considerations

Unique Aspects

Applications must be hypothesis-driven and milestone-oriented.

Studies should include a placebo arm.

Grant Details

natural products clinical trials healthcare research botanicals dietary supplements probiotics NCCIH NIH early phase trials
NCCIH Natural Product Early Phase Clinical Trial Award (R33)
PAR-25-270
NCCIH Grants
EDU NGO ENTERPRISE PUBLIC RESEARCH SME OTHER
US
HEALTHCARE OTHER
DEVELOPMENT OTHER
0-10 11-50 51-250 251-500 500+
SDG3
FUNDING RESEARCH_DEVELOPMENT
None
1050000.00
None
1050000.00
USD
None
Oct. 20, 2026, 10 p.m.
March 2025 - November 2026