NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)

The Department of Health and Human Services, through the National Institutes of Health (NIH) and the National Institute of Neurological Disorders and Stroke (NINDS), has issued a funding opportunity titled "NeuroNEXT Small Business Innovation in Clinical Trials." This initiative encourages small businesses to submit applications for exploratory clinical trials of investigational agents related to neurological disorders, aligned with NINDS's strategic plan. Awardees will leverage the NeuroNEXT infrastructure for trial execution and data coordination. The program accepts Phase II Small Business Innovation Research (SBIR) applications, allowing for a project budget of up to $3 million over a period of five years. Applications must adhere to a Community Engagement and Research Inclusion (CERI) plan. Key deadlines begin with the first application due date set for January 5, 2025, with subsequent deadlines throughout 2026 and 2027. Eligible applicants include U.S.-based small business concerns that are at least 50% owned by U.S. citizens or permanent residents. The program aims to foster public-private partnerships and enhance the development and commercialization of innovative therapies for neurological conditions, ultimately improving clinical outcomes and advancing neuroscience research. Interested parties are encouraged to engage with NINDS representatives for feasibility discussions before submitting their applications.