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

National Institutes of Health · Department of Health and Human Services · RFA-TR-25-002

In plain English

National Institutes of Health (Department of Health and Human Services) is accepting applications for this grant until Jul 2, 2027 (233 days left).

The listing does not state award amounts or the number of awards.

Eligible applicant types include nonprofits, small businesses, for-profit companies, state governments, local governments, tribal governments & organizations, colleges & universities, school districts and public housing authorities, plus others described in the listing.

The listing says cost sharing or matching is not required.

Built only from the fields in the Grants.gov listing. Always confirm on the official listing.

Key facts

StatusPosted: open for applications
Close dateJul 2, 2027 · 233 days left
Posted dateDec 6, 2024
Opportunity numberRFA-TR-25-002
AgencyNational Institutes of Health (Department of Health and Human Services)
Funding instrumentGrant
CategoryHealth
Opportunity categoryDiscretionary
Award ceiling (max per award)Not stated
Award floor (min per award)Not stated
Estimated total program fundingNot stated
Expected number of awardsNot stated
Cost sharing or matching requiredNo
Assistance listing (CFDA/ALN)93.350 – National Center for Advancing Translational Sciences
Last updated on Grants.govJun 5, 2026
Archive dateAug 1, 2027

Who can apply

Browse similar: Nonprofits · Small businesses · For-profit companies · State governments · Local governments · Tribal governments & organizations · Colleges & universities · School districts · Public housing authorities

  • 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 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 details in the listing)

Additional eligibility information (excerpt from the listing):

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. …

Description

Excerpt from the official synopsis on Grants.gov (shortened; read the full text on the official listing):

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.

Read the full listing on Grants.gov → · Agency's announcement page

Before you apply: organizations applying through Grants.gov generally need an active SAM.gov registration (with a Unique Entity ID) and a Grants.gov account, and registration can take several weeks, so start early. Check the official listing for the exact requirements, deadline time and time zone. This page is a summary, not the official notice, and not legal or financial advice.

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