Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
This NIH (R21) opportunity funds preclinical efficacy studies in established rare-disease models to demonstrate that a candidate therapeutic warrants further development, including supporting pharm…
- Deadline
- Jul 2, 2027
- Posted
- Dec 6, 2024
- Award amount
- Amount not specified
- Focus areas
- Health
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We’ll email you before Jul 2, 2027 so you have time to apply.
In plain English
This NIH (R21) opportunity funds preclinical efficacy studies in established rare-disease models to demonstrate that a candidate therapeutic warrants further development, including supporting pharmacokinetic and pharmacodynamic studies. Eligible applicants are U.S. research organizations including universities, government and tribal entities, and faith- or community-based organizations; foreign organizations and non-U.S. components are not eligible to apply, though some foreign components are allowed. It is intended for research teams advancing therapeutic candidates, not individuals or general nonprofits. Award amounts are not specified.
AI-generated summary to help you decide quickly — verify the official eligibility rules before applying.
Who can apply
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.
About this grant
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.
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