Open · 101 days left D National Institutes of Health

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

Funding
Not specified
Deadline
--
Days
--
Hrs
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Min
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Sec
Jun 02, 2026
Posted Dec 6, 2024 (441 days ago)
Closes Jun 2, 2026 (in 101 days)

Grant Details

Opportunity Number
RFA-TR-25-002
CFDA / ALN
93.350
Opportunity Category
Discretionary (D)
Funding Category
Health (HL)
Funding Instrument
Grant (G)
Cost Sharing
No Cost Sharing (No)

Eligibility

State governments (00) County governments (01) City or township governments (02) Special district governments (04) Independent school districts (05) Public and State controlled institutions of higher education (06) Native American tribal governments (Federally recognized) (07) Public housing authorities / Indian housing authorities (08) Native American tribal organizations (11) Nonprofits having a 501(c)(3) status with the IRS (12) Nonprofits without 501(c)(3) status (13) Private institutions of higher education (20) For-profit organizations other than small businesses (22) Small businesses (23) Others (25)

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.