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Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
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 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.
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 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.
Related ProgramsDepartment of Health and Human Services
National Center for Advancing Translational Sciences
Department of Health and Human Services
Agency: Department of Health and Human Services
Office: National Institutes of Health
Estimated Funding: $25,000,000
Office: National Institutes of Health
Estimated Funding: $25,000,000
Who's Eligible
Obtain Full Opportunity Text:
https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-23-016.html
Additional Information of 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 Institutions) 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.
Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/rfa-files/RFA-TR-23-016.html
Contact:
Agency Email Description:
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Agency Email:
Date Posted:
2023-07-05
Application Due Date:
Archive Date:
2025-07-08
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