Federal grant · National Institutes of Health

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

Status
Open
Posted
Dec 6, 2024
Closes
Jul 2, 2027
Est. total funding
—
Award range
—
Expected awards
—
Opportunity number
RFA-TR-25-002
Who can apply

Eligible applicants

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.

About this grant

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.

Instrument
Grant
Activity
Health
Assistance listings
93.350
Cost sharing
Not required
Last updated
Jun 5, 2026

From Grants.gov's public daily extract of Oct 25, 2026. Agency contacts, full eligibility and application packages are on Grants.gov; always confirm deadlines there before applying.

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