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

Open

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

PostedDec 6, 2024
Closing dateJul 2, 2027
Award ceilingNot listed
Expected awardsNot listed
From Grants.gov

Eligibility

Nonprofits are listed as eligible applicants.

  • Native American tribal governments (Federally recognized)
  • State governments
  • Special district governments
  • Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
  • City or township governments
  • For profit organizations other than small businesses
  • Independent school districts
  • Private institutions of higher education
  • Others (see text field entitled "Additional Information on Eligibility" for clarification)
  • Public housing authorities/Indian housing authorities
  • County governments
  • Small businesses
  • Public and state controlled institutions of higher education
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education

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.

Description

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.

Funding

Total program fundingNot listed
Award floorNot listed
Award ceilingNot listed
CategoryHealth
Assistance listing93.350,

Official sources

Last verified on Grants.gov Nov 4, 2026. Grantvello is not affiliated with Grants.gov or National Institutes of Health. The notice on Grants.gov is the binding text.