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

Due: Jun 2, 2026

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...

Eligible Applicants- 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

Additional Eligibility Information

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 Cont...

Funding TypeGrantCategories of Funding Activity- HealthOpportunity TypeDiscretionary

Grantor Contact InformationSee Section VII. Agency Contacts within the full opportunity announcement for all other inquires.Grantor Emailgrantsinfo@nih.govOther Grantor InformationNIH Grants Information<br/>grantsinfo@nih.gov

Additional Informationhttps://grants.nih.gov/grants/guide/rfa-files/RFA-TR-25-002.htmlSupporting Linkhttp://grants.nih.gov/grants/guide/rfa-files/RFA-TR-25-002.html

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