NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)

The National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH, has reissued its exploratory clinical trials grant program specifically for small businesses under the SBIR R43/R44 grant mechanism, designed to support the early clinical development of neurological disease interventions. This opportunity invites U.S.-based Small Business Concerns (SBCs) to conduct Phase I and II clinical trials, including exploratory studies of drugs, biologics, devices, and various therapies aimed at conditions aligned with NINDS’s mission. Applicants can propose single or multi-site studies (up to three sites), intended to generate critical data for advancing the technology towards commercialization. This funding opportunity emphasizes preparatory clinical studies, not definitive efficacy trials, reserving the latter for different NINDS mechanisms. This funding supports trials designed to optimize dosage, assess safety, or explore preliminary efficacy, which will allow applicants to make key decisions regarding the feasibility of progressing to Phase 3 trials. For device-based projects, the program provides flexibility to establish proof-of-concept and refine prototypes, thus supporting small businesses in navigating early regulatory hurdles. Proposals must present a solid scientific foundation, including prior nonclinical and clinical data, as well as regulatory documentation if FDA oversight is involved. Trials should incorporate randomization and blinding, where feasible, to support the transition towards large-scale efficacy testing. A key aspect of this grant is the required Plan for Enhancing Diverse Perspectives (PEDP), which ensures applicants are committed to diversity and inclusion within their research teams and project collaborations. Applicants are encouraged to structure teams with varied expertise across different scientific fields and to collaborate with institutions serving underrepresented groups. Proposals lacking a PEDP will be considered incomplete and withdrawn. The NIH highlights the value of diverse perspectives in fostering scientific innovation and enhancing research quality and outcomes, with guidance materials available for applicants on PEDP development. Funding limits are set at $700,000 in Phase I (up to $500,000 per year) and $3,000,000 in Phase II (up to $1,500,000 per year), with project durations up to two years for Phase I and three years for Phase II. NINDS advises applicants to align their budgets with project needs and encourages them to seek third-party financial partnerships for projects requiring substantial investment beyond Phase II. Third-party partners may include investors, other companies, or government entities. This provision is particularly significant for projects targeting smaller markets, such as rare diseases or young pediatric populations, which may be less appealing to large investors at early stages. The application process requires several registrations, including SAM, eRA Commons, and Grants.gov, all of which are essential for eligibility. Deadlines for applications are on January 5, April 5, and September 5, recurring annually through 2026. NINDS strongly encourages early communication with program staff to review project plans, timelines, and any specific regulatory requirements. Awardees will be expected to follow NIH policies on rigor and transparency and comply with all NIH submission guidelines. This funding opportunity emphasizes support for translational research, with SBCs positioned to drive innovation in treatments for neurological disorders. It is particularly suited for small businesses capable of leveraging the NIH's clinical research networks, such as NeuroNEXT and StrokeNet, for larger studies, thus enabling efficient recruitment and implementation.