Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
National Institutes of Health
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- Posted
- Dec 17, 2025
- Closes
- Jul 2, 2027 (in 351 days)
- Last verified
- Jul 16, 2026
Classification and identifiers
- Solicitation number
- RFA-TR-25-002
- Assistance listing (CFDA)
- 93.350
Amount
Amount not published by the funder
Who can apply
Small businesses, Private colleges and universities, and Nonprofits, including small and volunteer-run organizations can all apply here. Check the eligibility details below to see if your organization fits.
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 de...
About this opportunity
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.