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

Active
Yes
Status
Posted
Published Date
April 3rd, 2024
Close Date
June 2nd, 2026
Award Ceiling
$275,000.00
Opportunity No.
RFA-TR-24-023

Agency

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Summary

The National Institutes of Health (NIH) is offering a grant opportunity titled "Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)". This grant aims to provide funding for conducting efficacy studies in an established rare disease preclinical model. The goal is to demonstrate that a proposed therapeutic agent warrants further development. The supported studies will include preclinical efficacy, as well as accompanying pharmacodynamic and pharmacokinetic studies. The therapeutic agents can include small molecules, biologics, or biotechnology-derived products. The ultimate objective of this grant is to advance projects to a stage where they would attract subsequent investment for full Investigational New Drug (IND) application development or progression to clinical trials, particularly for repurposing or repositioning purposes. The grant has a maximum award ceiling of $275,000 and does not require cost sharing or matching. The eligibility criteria include various types of institutions and organizations, such as Alaska Native and Native Hawaiian Serving Institutions, Faith-based or Community-based Organizations, and U.S. Territories or Possessions. Non-domestic (non-U.S.) entities and components are not eligible to apply. The deadline for application submission is June 2, 2026. For more information and to apply, please visit the following link: Preclinical Proof of Concept Studies for Rare Diseases Grant. For any inquiries, please contact NIH Grants Information at grantsinfo@nih.gov.

Description

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.

Contact Information

Attachments
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Opportunity Lifecycle

Title
Type
Grant

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