Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
ID: 357570Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/357570

Additional Information

http://grants.nih.gov/grants/guide/rfa-files/RFA-TR-25-002.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a funding opportunity for preclinical proof of concept studies targeting rare diseases under the R21 Exploratory/Developmental Research Grant mechanism. This initiative aims to support efficacy studies in established preclinical models for therapeutic agents, including small molecules and biologics, with the goal of advancing projects toward Investigational New Drug (IND) applications. The funding is particularly significant as it addresses the unmet medical needs of approximately 30 million individuals in the U.S. affected by rare diseases, enhancing the likelihood of progressing novel therapies to clinical trials. The total funding available is up to $1,200,000 for FY26, with a maximum budget of $275,000 per two-year project. Interested applicants must submit their letters of intent by May 1, 2025, and can find more information by contacting NIH Grants Information at grantsinfo@nih.gov or visiting the opportunity's webpage at https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-25-002.html.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    RFA-TR-25-002-Full-Announcement.html
    RFA-TR-25-002.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH) and the National Center for Advancing Translational Sciences (NCATS), has released a funding opportunity for conducting preclinical proof of concept studies for rare diseases under the R21 Exploratory/Developmental Research Grant mechanism. The objective is to support efficacy studies in established preclinical models, focusing on therapeutics such as small molecules or biologics, aimed at advanced development leading to Investigational New Drug (IND) applications. Applicants are encouraged to form multidisciplinary collaborations and must include a detailed readiness assessment of therapeutic agents, a partnership plan with a rare disease oversight committee, and ensure rigorous adherence to application guidelines. The total funding available is up to $1,200,000 for FY26, with a maximum budget of $275,000 per two-year project. Applications must be submitted electronically through Grants.gov, with the first letter of intent due on May 1, 2025. The initiative aims to enhance the development of treatments for the estimated 30 million individuals in the U.S. affected by rare diseases, addressing significant unmet medical needs and increasing the likelihood of progressing novel therapies to clinical trials.
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