Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)
Open to U.S. universities, research institutions, nonprofits, and certain government/tribal organizations; foreign organizations are not eligible. This NIH R21 funds projects that improve clinical-…
- Deadline
- Jul 20, 2028
- Posted
- Sep 22, 2025
- Award amount
- Amount not specified
- Focus areas
- HealthIncome Security and Social Services
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In plain English
Open to U.S. universities, research institutions, nonprofits, and certain government/tribal organizations; foreign organizations are not eligible. This NIH R21 funds projects that improve clinical-trial readiness for rare diseases — developing biomarkers and outcome measures, or characterizing a disease's course to enable future trials. Award size follows standard R21 limits.
AI-generated summary to help you decide quickly — verify the official eligibility rules before applying.
Who can apply
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); 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. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
About this grant
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.
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