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

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Key Information

Due Date: June 2, 2025


Agency: U.S. Department of Health and Human Services (HHS)


Source: Federal


Funding Category:

Health & Human Services

Funding Amount: Not Specified


Funding Type: Grant


Match Required: No


Contact Info: grantsinfo@nih.gov
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

Overview

This text is about a funding opportunity notice, also known as NOFO, that is centered around Preclinical Proof of Concept Studies for Rare Diseases. Specifically, the aim of this NOFO is to support efficacy studies that are carried out in an already established model for preclinical rare disease research. These studies should be able to showcase that a proposed therapeutic agent is worthy of further development.

The types of therapeutic agents can range from small molecules, biologics, to biotechnology-derived products. Moreover, this funding opportunity also caters to pharmacodynamic and pharmacokinetic studies that accompany the preclinical efficacy studies.

One of the primary objectives of this NOFO is to stimulate the development of therapies for rare diseases by advancing pertinent projects. This would be achieved when these projects reach a point where they draw further investment, which would then support the full development of an Investigational New Drug (IND) application. Alternatively, it could also lead to its progression to clinical trials, especially when it comes to repurposing or repositioning.

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Key Dates

Open Date: July 5, 2023


Application Due Date: June 2, 2025


Estimated Award Date: Not Specified

Additional Details

Eligible Activities

  • Research and Development

Eligible Applicants

  • State governments
  • County governments
  • City, village or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Private institutions of higher education
  • Small businesses

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