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NCATS Clinical Trial Readiness for Rare Diseases

NCATS Clinical Trial Readiness for Rare Diseases

Funds U.S. researchers and companies generating natural history data, biomarkers, and outcome measures needed to design clinical trials for rare diseases.

OpenNational Center for Advancing Translational SciencesUnited States
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About

NCATS Clinical Trial Readiness for Rare Diseases is an R21 exploratory grant run by the National Center for Advancing Translational Sciences (NCATS) under the NIH. The program operates under PAR-25-450, a rolling program announcement with six deadlines spanning 2026 through 2028. Awards cover up to $275,000 in direct costs over a two-year project period, with no more than $200,000 allowable in any…

What this grant funds

Rare diseases (affecting fewer than 200,000 people in the U.S.); natural history studies; biomarker identification and validation; outcome measure development and validation; disease model development for clinical trial design. Not for interventional studies or model validation without clear clinical trial linkage.

Key facts
CycleiHow often this grant runs — e.g. annually, on a rolling basis, or a one-off call.Twice a year
Next deadlineiThe next date applications are due. Rolling means you can apply any time.17 Feb 2027
Decision timeiTypical time from the deadline to the funder's decision.34 weeks
Project durationiHow long the funded work is expected to run.24 months
Award typeiThe form of funding — grant, equity, loan, tax credit, etc.Grant
Match fundingiThe share of project costs you must cover yourself. 0% = fully funded.0%
Funding pooliThe total budget available across all awards in this round.—
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Last verified: 22 Jul 2026Source: grants.nih.gov