Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
Open Posted
- Opportunity number
- RFA-TR-25-002
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- City/Township Governments
- For Profit Organizations
- Independent School Districts
- Other
- Special District Governments
- Tribal Governments (Federally Recognized)
- Non-501(c)(3) Nonprofits
- County Governments
- Public or Indian Housing Auth.
- Small Businesses
- Tribal Organizations (Not Federally Recognized)
- Higher Education Inst. (Private)
- State Governments
- Higher Education Inst. (Public)
- 501(c)(3) Nonprofits
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health National Center for Advancing Translational Sciences (NCATS) is soliciting applications for preclinical proof of concept studies in rare diseases, with an application due date of July 2, 2027. This R21 mechanism does not allow clinical trials.
Eligible applicants include higher education institutions (public and private), 501(c)(3) nonprofits, small businesses, for-profit organizations, state and local governments, tribal governments (federally recognized and other), tribal organizations, faith-based and community-based organizations, HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, TCCUs, and U.S. territories. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible; foreign components as defined in the NIH Grants Policy Statement are allowed.
Funding supports efficacy studies in established rare disease preclinical models, with accompanying pharmacodynamic and pharmacokinetic studies. Therapeutic agents include small molecules, biologics, and biotechnology-derived products. The program aims to advance projects to the point where they attract subsequent investment for full IND application development or progression to clinical trials in cases of drug repurposing or repositioning.
Evaluation criteria emphasize scientific merit and significance, technical adequacy of experimental design, investigator competency, facility adequacy, budget necessity relative to project scope, relevance to program objectives, and fund availability. Initial peer review by committees of biomedical research authorities precedes NCATS Advisory Council review for award recommendations.
The opportunity operates under CFDA 93.350. Award period is 1 to 7 years. Financial and programmatic records must be retained for 3 years from submission of annual financial status reports.
Synopsis
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.
Eligibility
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); Non-domestic (non-U.S.) Entities (Foreign Organizations); 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 allowed.
Files
| File | Type | Posted |
|---|---|---|
| RFA-TR-25-002-Full-Announcement.html | HTML file | |
| PKG00289494.pdf |
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