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

Updated Oct 20, 2026

Grant from the National Institutes of Health, open to small businesses. Closes Jul 2, 2027, 255 days left.

Opportunity number	RFA-TR-25-002
Agency	National Institutes of Health
Funding type	Grant
Field	Health
Cost sharing or matching	Not required
Assistance listing	93.350
Posted	Dec 6, 2024
Closes	Jul 2, 2027 (255 days left)
Add the deadline to	Google Calendar

Who can apply

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 and Indian housing authorities
Native American tribal organizations (other than federally recognized tribal governments)
Nonprofits with 501(c)(3) status, other than institutions of higher education
Nonprofits without 501(c)(3) status, other than institutions of higher education
Private institutions of higher education
For-profit organizations other than small businesses
Small businesses
Others (see the eligibility notes)

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.

Full announcement and how to apply on Grants.gov

Health grants right now

There are 350 open federal grants in health that small businesses may apply for; 33 close within 30 days. The median award ceiling is $500,000. The agencies offering the most are National Institutes of Health, Centers for Disease Control and Prevention - ERA and Centers for Disease Control - NCBDDD. Grants in this field stay open a median of 1031 days; this one is open for 938 days.

Who has won this program before

Duke University $200.6 million · from Sep 21, 2016
Duke University $139.8 million · from Jan 1, 2017
University Of Pittsburgh - Of The Commonwealth System Of Higher Education $128.8 million · from Jul 12, 2016
Vanderbilt University Medical Center $118.6 million · from Jun 1, 2017
University Of California, LOS Angeles $118.1 million · from Jul 1, 2016

The largest grants and cooperative agreements under assistance listing 93.350 with payments since Oct 1, 2025, from USAspending.gov. Amounts are each award's total.