Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
National Center for Advancing Translational Sciences (NCATS) · NIH Institute/Center · RFA-TR-25-002
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 2, 2027
- 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).
- One-time
- Open dateWhen applications open (or opened).
- Dec 6, 2024
- 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 FY2025 NCATS R21 applications (13 of 98 applications awarded).
Payline: NIH discontinued percentile paylines for 2026 under its Unified Funding Strategy ↗ — scores are now weighed in context rather than against a fixed cutoff.
NCATS R21, FY2025 — atypical NIH funding year (multi-year upfront funding / rescinded paylines); NIH reports FY2025 success rates as not comparable to prior years.
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) provides funding to conduct efficacy studies in an established rare disease preclinical model to demonstrate that a proposed therapeutic agent warrants further development. In addition to preclinical efficacy, accompanying pharmacodynamic and pharmacokinetic studies would be supported. Therapeutic agents include small molecules, biologics or biotechnology-derived products. The goal of this NOFO is to spur therapeutic development for a variety of rare diseases by advancing projects to the point where they would attract subsequent investment supporting full Investigational New Drug (IND) application development or progression to clinical trials in the case of repurposing or repositioning.
Data notes: award amount not published in the source feed.