Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)
National Institutes of Health (NIH) · NIH Institute/Center · PAR-25-450
Source: Grants.gov · View original posting ↗
- AwardWhat a single award can be worth — the funder's published per-award amount or floor–ceiling range.
- Amount not listed
- DeadlineFinal application due date.
- Jul 20, 2028
- Letter of intentDue date for the letter of intent (a short pre-application some funders require or request before the full proposal).
- —
- MechanismNIH activity code — the grant type (R01 research project, R21 exploratory, K series career development, F series fellowship, …).
- R21
- DurationMaximum project period for a single award.
- —
- Expected awardsHow many awards the funder anticipates making under this opportunity.
- —
- Funding cycleHow often the program accepts applications (annual, multiple cycles per year, rolling, or one-time).
- Standard NIH dates
- Open dateWhen applications open (or opened).
- Sep 22, 2025
- Total fundingThe overall pool the funder expects to commit across ALL awards under this opportunity — not what one project receives.
- —
- Clinical trialWhether proposed projects must, may, or must not include a clinical trial.
- Not allowed
Funding context
Based on FY2024 NIH (all institutes) R21 applications (1,837 of 11,592 applications awarded).
Institute-specific data wasn’t available — showing the NIH-wide rate for this mechanism.
Payline: NIH discontinued percentile paylines for 2026 under its Unified Funding Strategy ↗ — scores are now weighed in context rather than against a fixed cutoff.
NIH-wide R21, all institutes.
Aggregate historical data by institute, mechanism, and fiscal year — context for planning, not a prediction for this opportunity. Source ↗
Research areas
Auto-classified from the title and description (keyword-based) — may be imperfect.
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.
Data notes: award amount not published in the source feed; administering NIH institute could not be identified from the opportunity number.