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

The summary for the Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the National Institutes of Health, which is the U.S. government agency offering this grant.

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

Federal Grant Title:	Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
Federal Agency Name:	National Institutes of Health (HHS-NIH11)
Grant Categories:	Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-TR-25-002
Type of Funding:	Grant
CFDA Numbers:	93.350
CFDA Descriptions:	Information not provided
Current Application Deadline:	June 2nd, 2026
Original Application Deadline:	June 2nd, 2026
Posted Date:	December 6th, 2024
Creation Date:	December 6th, 2024
Archive Date:	July 8th, 2026
Total Program Funding:
Maximum Federal Grant Award:
Minimum Federal Grant Award:
Expected Number of Awards:
Cost Sharing or Matching:	No
Last Updated:	December 6th, 2024

Applicants Eligible for this Grant: State governments - County governments - City or township governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - Native American tribal organizations (other than Federally recognized tribal governments) - Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education - Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education - Private institutions of higher education - For-profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on 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.
Link to Full Grant Announcement: https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-25-002.html
Grant Announcement Contact: NIH Grants Information
[email protected]
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
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