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Facilitating T1 Translational Aging Research: Preclinical and Early Phase Human Studies (UG3/UH3 Clinical Trial Optional)

National Institutes of Health

This Notice of Funding Opportunity (NOFO) invites applications on T1 translational aging research (i.e., bench to bedside) which focus on advancing new therapeutics from preclinical stages to first-in-human (FIH) trials for aging-related conditions, such as sarcopenia, heart failure with preserved ejection fraction (HFpEF), and deficits such as immunosenescence. This NOFO supports the following two categories of milestone-driven projects:

1) Traditional de novo drug development (i.e., new chemical/molecular entities) with one of the following entry points to the translational pipeline:
- Screening through preclinical validation, or
- Hit to lead through Investigational New Drug Application (IND), or
- Late-stage preclinical development through FIH studies, and

2) Data-driven computational drug repurposing strategies with subsequent validation of predictions and generation of proof-of-concept data in pertinent animal models and/or in human in vitro studies. For the purposes of this NOFO, drug repurposing (also known as drug repositioning, reprofiling or re-tasking) refers to approaches for identifying alternative uses for drugs approved by the United States Food and Drug Administration (FDA) or investigational therapeutics which are beyond the scope of the original intended clinical indication.

This NOFO utilizes the UG3 / UH3 Exploratory/Developmental Phased Award Cooperative Agreement activity code. The UG3 phase will support T1 translational research planning activities and preliminary studies. The UH3 phase will enable more comprehensive pharmacology and/or toxicology evaluations of the proposed therapeutics, including replication studies to confirm preliminary findings or experimental validation of predictive models. Transition to the UH3 phase will be based on achievement of UG3 milestones proposed by the investigators.

Applications that focus on neurodegenerative diseases and Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD) are outside the scope of this NOFO.

Deadlines:

Letter of Intent: December 10, 2024
Application: January 10, 2025

RFA-AG-25-027 Expiration Date January 11, 2025

Specialties

Cell Biology

Data Science

Geriatrics & Gerontology

Clinical Trials

Genetics & Genomics

Molecular Biology

Eligibility Requirements

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Local Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

Eligible Agencies of the Federal Government
U.S. Territory or Possession

Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations

Foreign Organizations

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 not allowed.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

Sponsor Details

Sponsor Institute/Organizations: National Institutes of Health

Address: National Institutes of Health; 31 Center Drive; MSC 2220; Bethesda; MD 20892-2220; USA

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