Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
Federal funding opportunity RFA-TR-25-002 from National Institutes of Health (Department of Health and Human Services).
Apply on Grants.gov →Application closes July 2, 2027
- Posted
- December 6, 2024
- Closes
- July 2, 2027
- Cost sharing
- No
- Instrument
- Grant
- Assistance listing
- 93.350
- Category
- Health
- Archives
- August 1, 2027
Program funding history
Awards made under Assistance Listing 93.350 across FY2024–FY2026, from public federal spending records.
- FY2024 obligated
- $588.2M
- FY2025 obligated
- $599.3M
- FY2026 (to date) obligated
- $281.4M
- Awards in window
- 886
Top recipients: Vanderbilt University Medical Center, Regents of the University of Michigan, University of Pittsburgh - of the Commonwealth System of Higher Education, Icahn School of Medicine at Mount Sinai, The Johns Hopkins University
Source: USAspending.gov · refreshed July 2026
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.
Who can apply
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- 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
- City or township governments
- Independent school districts
- Private institutions of higher education
- For profit organizations other than small businesses
- County governments
- Public housing authorities/Indian housing authorities
- Small businesses
- State governments
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Special district governments
- Native American tribal organizations (other than Federally recognized tribal governments)
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.
How to apply
Applications go through the official government listing. Grants Radar links you straight to the source.
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