health · HHS-NIH11

Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)

National Institutes of Health · RFA-TR-25-002

313 days left

Deadline

July 2, 2027

GRANTQUICK SUMMARYPlain-English Overview

Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed). National Institutes of Health. 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... Funding amounts not specified.

Who Should Apply

City/township governments, For-profit organizations, Independent school districts, Other eligible entities, Special district governments (+10 more)

Who Should NOT Apply

Organizations not matching the eligible applicant types listed above

Key Requirements (Plain English)

•Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Isl...
•Deadline: 2027-07-02

💡 GrantQuick Tip

Focus your proposal on clear outcomes, alignment with agency priorities, and demonstrate organizational capacity.

Competitiveness: Moderate to high — federal grants are always competitive

What This Grant Funds

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.

Attachments

PDF

RFA-TR-25-002 Full Announcement Text

RFA-TR-25-002-Full-Announcement.html

Who Can Apply

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.

Eligible Applicant Types

City/Township GovernmentsFor-Profit OrganizationsIndependent School DistrictsOther (see NOFO for details)Special District GovernmentsFederally Recognized Tribal GovernmentsNonprofits without 501(c)(3)County GovernmentsPublic And Indian Housing AuthoritiesSmall BusinessesOther Tribal OrganizationsPrivate Colleges & UniversitiesState GovernmentsPublic Colleges & Universities501(c)(3) Nonprofits

Funding Details

Cost Sharing Required?: No
Funding Instrument: grant

Key Dates

Posted: December 6, 2024

Application Deadline: July 2, 2027 (313 days remaining)

Agency Contact

NIH Grants Information grantsinfo@nih.gov

grantsinfo@nih.gov

Ready to apply?

View the full NOFO and submit your application on Grants.gov

View on Grants.gov