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.
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…
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.
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