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

Background
This Notice of Funding Opportunity (NOFO) from the National Institute on Aging (NIA) invites applications for T1 translational aging research, focusing on advancing new therapeutics from preclinical stages to first-in-human trials for aging-related conditions such as sarcopenia and heart failure with preserved ejection fraction.

The goal is to support milestone-driven projects in two categories: traditional drug development and data-driven computational drug repurposing strategies.

Grant Details
The NOFO supports two categories of projects:
1) Traditional de novo drug development with entry points including screening through preclinical validation, hit to lead through IND, or late-stage preclinical development through FIH studies;
2) Data-driven computational drug repurposing strategies with validation of predictions and proof-of-concept data generation in animal models or human in vitro studies.

The UG3 phase will support planning activities and preliminary studies, while the UH3 phase will enable comprehensive pharmacology and toxicology evaluations, including replication studies and experimental validation of predictive models. Proposed activities may include pilot studies, compound screening, assay development, pharmacodynamic biomarker identification, and initial IND-enabling toxicology studies.

Eligibility Requirements
Eligible applicants include higher education institutions (public/state controlled, private), nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), local/state/county governments, tribal governments, federal agencies, and other organizations such as independent school districts and public housing authorities. Non-domestic entities are not eligible to apply.

Period of Performance
The maximum project period for the UG3/UH3 award is 5 years; the UG3 phase may not exceed 2 years while the UH3 phase may not exceed 3 years.

Grant Value
NIA intends to commit $2,500,000 in fiscal year 2025 to fund up to five awards. Application budgets may not exceed $350,000 in direct costs per year for the UG3 phase and $700,000 in direct costs per year for the UH3 phase.