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

The NIH's Innovation Grants to Nurture Initial Translational Efforts (IGNITE) program invites applications through its Neurotherapeutic Agent Characterization and In Vivo Efficacy Studies (R61/R33) funding opportunity, managed by the National Institute of Neurological Disorders and Stroke (NINDS). This grant supports translational research to evaluate the pharmacokinetics, pharmacodynamics, and in vivo efficacy of small molecule or biologic neurotherapeutic agents intended for neurological and neuromuscular disorders under the NINDS mission. The two-phased R61/R33 mechanism includes an R61 phase to demonstrate feasibility and an R33 phase for further efficacy studies, each with specific criteria and milestones that must be met to progress to the next phase. Applications for this funding opportunity are due annually on specified dates, with the first deadline on February 18, 2025. The primary aim of this funding opportunity is to advance potential neurotherapeutic agents through preclinical characterization and validation. The R61 phase emphasizes the preparation and characterization of the therapeutic agent, including pharmacokinetics and early efficacy studies. This includes validating the agent's distribution to and interaction with the target site in animal models and demonstrating a viable therapeutic approach. The R33 phase, contingent on successful completion of R61 milestones, involves more in-depth pharmacodynamic and in vivo efficacy studies to further confirm the agent's potential therapeutic effect and dose-response relationships. The grant does not support drug optimization, IND-enabling studies, or clinical trials. Applicants must provide specific plans, including a Plan for Enhancing Diverse Perspectives (PEDP), a robust intellectual property (IP) strategy, and a clear delineation of milestones. The PEDP should outline strategies to incorporate diverse scientific perspectives in the project to enhance its quality and impact. A thorough IP strategy must also be presented, detailing any IP constraints and strategies for protecting and managing intellectual property generated through the project. The proposed research plan should include quantifiable milestones for the R61 to R33 transition, to be reviewed as a part of the project’s feasibility. The award budget for each phase is capped at $499,000 per year, with a total project period of three years. The grant supports various eligible entities, including higher education institutions, nonprofits, for-profits, local governments, and foreign organizations. Small businesses eligible for SBIR and STTR programs are encouraged to apply through those avenues to utilize targeted resources for small enterprises. Applications will be reviewed based on the significance, rigor, and feasibility of the proposed research, the relevance of the therapeutic agent, the IP strategy, and the qualifications of the research team. The plan to enhance diverse perspectives will also influence the evaluation of the scientific merit of the project. Applications must include all specified components to be reviewed, and those lacking required elements like the PEDP will be administratively withdrawn. The IGNITE program represents an important funding opportunity for research aimed at translating discoveries in neurotherapeutics from the laboratory toward clinical applications. Interested applicants are advised to contact the NINDS program officers to discuss project suitability and review the NIH guidance on rigorous study design and transparent reporting. Additional details regarding application requirements, timelines, and review processes are outlined in the funding announcement, with resources and support available through the NIH eRA Commons and Grants.gov.