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

The NeuroNEXT Small Business Innovation in Clinical Trials funding opportunity, managed by the National Institute of Neurological Disorders and Stroke (NINDS) under the National Institutes of Health (NIH), supports exploratory clinical trials through a cooperative agreement mechanism (U44). This initiative encourages applications from U.S.-based small business concerns to test investigational drugs, biologics, surgical therapies, or devices, or to conduct biomarker validation studies aligned with the strategic priorities of NINDS. The overarching goal is to facilitate product development and improve clinical trial efficiency in neuroscience, using the established NeuroNEXT infrastructure. NeuroNEXT includes a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC), and a network of geographically distributed clinical sites. Awardees will be granted access to these resources following peer review and prioritization. Support includes study implementation assistance, statistical and data management services, recruitment, retention, and on-site protocol execution. Applicants do not need to be affiliated with the NeuroNEXT infrastructure to apply, and ad hoc clinical sites may be proposed if needed for the study. Investigators are encouraged to contact NINDS staff before submission to assess feasibility and alignment. This funding opportunity supports SBIR Phase II applications and encourages trials that inform subsequent larger studies or pivotal trials. It prioritizes studies with a strong scientific rationale, appropriate design, and potential commercial impact, especially when independent third-party investment is secured. Trials focused on stroke, single-site studies, or nonclinical research are not eligible. Rare disease applications are welcomed, and innovative adaptive trial designs are encouraged in such cases. Studies must incorporate a Community Engagement and Research Inclusion (CERI) Plan to ensure diversity, equity, and community representation in research design and implementation. Applicants may request up to $3 million in total costs annually for up to five years. Prior consultation with NINDS is required for budgets above this threshold. NIH allows pre-award costs and accepts applications on standard NIH SBIR due dates through January 2028. Awards are contingent upon scientific merit and NIH funding availability. Applications must be submitted via NIH ASSIST, Grants.gov, or an institutional S2S system and comply with all SBIR-specific and NIH submission requirements outlined in the application guide. Evaluation criteria include scientific merit, project feasibility, innovation, commercialization potential, and the strength of the CERI Plan. The peer review process will consider applicant qualifications, study significance, and alignment with NINDS priorities. NINDS retains the right to terminate support if milestones are unmet. Awardees must comply with NIH policies, including clinical trial registration, human subjects protection, and data sharing expectations.