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

Does this fit your business?

This is an NIH R21 grant for preclinical proof-of-concept studies of therapies for rare diseases — efficacy, pharmacodynamic and pharmacokinetic work in established disease models, aimed at getting a project to IND-enabling stage. It fits biotech and life-science businesses, universities, and nonprofits that already have a therapeutic candidate and a disease model to test it in. Retail, software, finance, and any organization without a therapeutic development pipeline should not bother.

Best for

Biotech and life-science small businesses with a therapeutic candidate for a rare disease, Universities and research institutions running preclinical rare-disease studies, Nonprofits and disease foundations advancing a therapy toward IND-enabling stage, For-profit drug-development companies preparing for IND or clinical trials

Not for

Retail, e-commerce, finance, housing, and other businesses outside biotech or therapeutic R&D, Foreign organizations or foreign components of U.S. organizations, Companies with no therapeutic candidate or no established rare-disease model to test in

These are our matcher’s estimates for a typical business in each industry. A real match depends on your size, your state and what you need the money for — check your own fit.

What this funds

Money can be used for

Research, R&D

Who can apply

Small businesses, For-profit companies, Nonprofits, State and local governments, Tribal governments and organizations, Colleges and universities, Other applicants (see eligibility)

Questions about this grant

When is the application deadline?

July 2, 2027.

Who can apply for this grant?

Small businesses, for-profit organizations, nonprofits (with or without 501(c)(3) status), public and private institutions of higher education, state, local, county, city and special district governments, federally recognized and other Native American tribal governments and organizations, public housing authorities, independent school districts, and certain other institutions such as HBCUs, Hispanic-serving institutions, and Alaska Native and Native Hawaiian serving institutions. Foreign organizations are not eligible, and foreign components of U.S. organizations cannot apply.

Can a sole proprietor or single-member LLC apply?

The facts do not say. The eligibility list names small businesses and for-profit organizations generally, but it does not specifically address sole proprietors or single-member LLCs, so that is not published here.

Can a nonprofit apply?

Yes. Nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status (other than institutions of higher education) are both listed as eligible applicants.

Summary

NIH R21 grants to conduct preclinical proof-of-concept efficacy, pharmacodynamic and pharmacokinetic studies of therapeutic agents (small molecules, biologics) in established rare disease models, advancing projects toward IND-enabling stage. Eligible applicants include small businesses, for-profits, nonprofits, universities, and state/local/tribal governments; foreign entities are not eligible.

About this grant

Who can apply

Topics and uses of funds

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