§ Federal grant opportunity · RFA-TR-25-002
Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
National Institutes of Health is accepting applications for Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed). The deadline is July 2, 2027 and the published award range is Award amount not published.
Key facts
- Funder
- National Institutes of Health
- Application deadline
- July 2, 2027
- Award range
- Award amount not published
- Eligibility
- 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.
- Geography
- United States
- Focus areas
- Health
- Opportunity number
- RFA-TR-25-002
Program overview
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.
How to apply
- Confirm your organization meets the eligibility criteria above.
- Read the full funding opportunity announcement from National Institutes of Health.
- Draft your narrative against the funder's stated priorities and review criteria.
- Submit before July 2, 2027, allowing time for registration and validation.
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