Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed)

Background
The Innovation Grants to Nurture Initial Translational Efforts (IGNITE) program, administered by the National Institutes of Health (NIH) and specifically the National Institute of Neurological Disorders and Stroke (NINDS), aims to support research that translates discoveries into new treatments for neurological and neuromuscular disorders. This funding opportunity focuses on pharmacodynamic, pharmacokinetic, and in vivo efficacy studies to demonstrate the biological activity of therapeutic agents, which may include small molecules or biologics, to warrant further development.

Grant Details
This NOFO provides funding for the following tasks:

1) Conduct pharmacodynamic studies to determine target occupancy and proximal target activation;

2) Perform pharmacokinetic studies to assess absorption, distribution, metabolism, and excretion of therapeutic agents;

3) Execute in vivo efficacy studies to evaluate the therapeutic agent's effects on endpoints closely tied to desired clinical outcomes;

4) Develop dosage forms and confirm therapeutic agent characterization including purity and stability;

5) Establish milestones for transitioning from R61 phase (preparatory activities) to R33 phase (efficacy studies), ensuring distinct phases without overlap. The R61 phase focuses on preparatory activities while the R33 phase emphasizes in vivo efficacy studies with established therapeutic agents.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local governments, state governments, tribal governments, and foreign organizations. Special encouragement is given to institutions such as Historically Black Colleges and Universities (HBCUs) and other minority-serving institutions. Individuals from diverse backgrounds are also encouraged to apply.

Period of Performance
The total project period may not exceed three years, with a maximum of two years allocated for each of the R61 and R33 phases. The R61 phase must be completed before transitioning to the R33 phase.

Grant Value
Direct costs cannot exceed $499,000 in any one year. Cumulative direct costs for the entire three-year project period may not exceed $750,000.