NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)

The National Institute of Neurological Disorders and Stroke (NINDS), a component of the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services, is offering funding through the Small Business Technology Transfer (STTR) grant mechanism under the activity code R41/R42. This reissued funding opportunity (PAR-24-044) supports exploratory clinical trials proposed by Small Business Concerns (SBCs) that aim to develop diagnostics, therapeutics, or devices aligned with the mission of NINDS. The opportunity is particularly designed to support projects that require early-stage clinical data to justify a future trial aimed at determining definitive efficacy, such as a Phase 3 drug trial or a pivotal device trial. Eligible applicants must be U.S.-based SBCs that meet specific ownership and operational criteria as defined by the SBIR/STTR Reauthorization Act. Applications can propose studies of drugs, biologics, devices, surgical techniques, behavioral therapies, or rehabilitation interventions. The opportunity allows single or multi-site trials, capped at three clinical sites. Emphasis is placed on early studies that provide initial insights into safety, dosing, and feasibility. Mid-stage trials should support go/no-go decisions by incorporating randomization, blinding, and predefined outcomes. All applications must articulate a future development plan should results prove favorable. The total budget for Phase I may not exceed $700,000, with a per-year cap of $500,000. For Phase II, the ceiling is $3,000,000, with a $1,500,000 per-year cap. The project period is limited to 2 years for Phase I and 3 years for Phase II. A regulatory plan is mandatory at the time of application, along with documentation of IND/IDE status or exemption where applicable. Fast-Track applications are permitted, and applicants are encouraged to engage with NINDS staff at least 12 weeks before submission to ensure alignment with program requirements. Applications are accepted on NIH standard due dates: January 5, April 5, and September 5 annually through September 5, 2026. Letters of intent should be submitted 30 days prior to the chosen deadline. Review and award decisions follow the NIH cycle, with earliest possible start dates ranging from July to April depending on submission timing. This opportunity is recurring, with the next anticipated cycle opening in January 2026 based on the established pattern. Applicants must provide a Community Engagement and Research Inclusion (CERI) Plan and a clear outline of their trial's scientific rationale, design, and endpoints. Additionally, strong encouragement is given to collaborate with existing NIH clinical networks such as NeuroNEXT, StrokeNet, and EPPIC-Net. Ancillary studies and applications primarily aimed at discovering biomarkers or estimating effect size for power calculations are not eligible under this opportunity. Contact for scientific inquiries is Dr. Emily Caporello at emily.caporello@nih.gov.