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

The National Institutes of Health (NIH), through its National Institute of Neurological Disorders and Stroke (NINDS), announces a reissued funding opportunity under the Small Business Innovation Research (SBIR) program for exploratory clinical trials. This program, identified by funding opportunity number PAR-23-311, targets small business concerns (SBCs) aiming to conduct Phase I or II clinical trials aligned with the mission of NINDS. The goal is to support the development of novel diagnostics and treatments for neurological diseases, addressing the funding gap often referred to as the "Valley of Death" that hinders the progression of early-stage regulated biomedical technologies. The funding opportunity is specifically tailored to exploratory clinical trials designed to inform future, more definitive trials. It supports a range of study types, including early-phase evaluations of drugs, biologics, devices, and interventions such as surgical, behavioral, or rehabilitation therapies. Studies may include single-site or multi-site (up to three sites) designs and must aim to generate robust, preliminary data. Projects involving FDA-regulated products must demonstrate regulatory readiness with appropriate approvals at the time of application. Applications proposing trials with a primary focus on establishing definitive efficacy, multi-site efforts beyond three sites, or early-stage preclinical activities are not eligible. Applicants may request up to $700,000 in total costs for Phase I projects (not to exceed $500,000 in any year) and up to $3,000,000 for Phase II (capped at $1,500,000 per year). Award periods are limited to two years for Phase I and three years for Phase II. Proposals exceeding standard caps may be accepted under special NIH waivers for select topics, but applicants are encouraged to consult with program officers early during planning. Matching funds are not explicitly required. The number of awards is contingent upon the availability of appropriated funds and submission of meritorious proposals. Eligible applicants are limited to U.S.-based small businesses. Specific eligibility criteria include majority ownership by U.S. citizens or permanent residents, registration through federal systems such as SAM.gov and eRA Commons, and compliance with performance benchmarks for Phase I to Phase II transition and commercialization. Companies with poor past performance on these benchmarks may face temporary ineligibility. Applications are accepted on a rolling cycle with standard NIH due dates: January 5, April 5, and September 5 each year through September 2026. Letters of intent are strongly encouraged at least 30 days before each deadline. The review process includes scientific merit evaluation, advisory council review, and award notification. Applicants must follow the NIH Application Guide instructions for SBIR and may use NIH ASSIST, Grants.gov Workspace, or institutional systems to apply. Contact for scientific inquiries is Emily Caporello, Ph.D., who can be reached via email at emily.caporello@nih.gov. Applications must conform to detailed standards of scientific rigor, ethical compliance, and data sharing expectations outlined by NINDS, including leveraging available NIH resources and clinical networks like NeuroNEXT and StrokeNet. This opportunity recurs annually. The next due date is January 5, 2026, with subsequent cycles continuing through at least November 17, 2025. Applications are due by 5:00 PM local time of the applicant’s institution, and early submission is recommended to allow for corrections during the validation process.