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Open (posted) · Grant

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

National Institutes of Health, Department of Health and Human Services

Key facts

Copied from the official Grants.gov record. Last verified October 29, 2026.

Program name
Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
Issuing agency
National Institutes of Health (Department of Health and Human Services)
Opportunity number
RFA-TR-25-002
Funding type
Grant
Funding purpose
Health
Status
Open (posted)
Application deadline
Closes July 2, 2027
Published award range
Not published by the agency
Cost sharing or match required
No
Eligible applicants (official categories)
  • 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 Additional Information on Eligibility)
Relevant to
Businesses and NonprofitsHow we determined this: Grants.gov eligibility includes small businesses or for-profit organizations. Grants.gov eligibility includes nonprofit organizations.
Geographic restrictions
None stated in structured data (federal opportunities are often nationwide). Check the eligibility details and full announcement for any limits.
Assistance Listing (CFDA)
93.350
Application URL
www.grants.gov/search-results-detail/357570 ↗Apply through Grants.gov (Workspace) using the application package on the official listing, unless the full announcement names a different submission system.
Source identifier
Grants.gov opportunity ID 357570 · Funding opportunity number RFA-TR-25-002
Posted
December 6, 2024 · Source last updated June 5, 2026
Last verified
October 29, 2026 (against Grants.gov)
Data completeness
92% of key fields published by the sourceNot published: published funding range.
Record confidence
highVerified against the official source; key fields present; no open issues.

Eligibility details (from the agency)

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 (from the official listing)

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.

Agency contact

NIH Grants Information grantsinfo@nih.gov
grantsinfo@nih.gov

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