Grants.govNational Institutes of Health

Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)

Posted Sep 22, 2025·open

AGENCY

HHS-NIH11

PROGRAM

Discretionary

AMOUNT

—

CLOSES

Jul 20, 2028

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Description

This Notice of Funding Opportunity (NOFO) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in rare diseases. The initiative seeks applications that are intended to facilitate rare diseases research by enabling efficient and effective movement of candidate therapeutics or diagnostics toward clinical trials, and to increase their likelihood of success. This could be through the development and testing of rigorous biomarkers and clinical outcome assessment measures, or by defining the presentation and course of a rare disease to enable the design of upcoming clinical trials.

Eligibility

Native American tribal governments (Federally recognized); For profit organizations other than small businesses; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Native American tribal organizations (other than Federally recognized tribal governments); Private institutions of higher education; Others (see text field entitled "Additional Information on Eligibility" for clarification); City or township governments; Special district governments; Public housing authorities/Indian housing authorities; Small businesses; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; State governments; County governments; Independent school districts; Public and State controlled institutions of higher education

Contact

National Institutes of Health

grantsinfo@nih.gov

301-402-2541

Additional details

Funding instrument: Grant
Cost sharing required: No
Archived: Aug 25, 2028

Opportunity number: PAR-25-450

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