NINDS Efficacy and Exploratory Clinical Trials (UG3/UH3 - Clinical Trial Required)

The National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH) under the Department of Health and Human Services, is preparing to publish a Notice of Funding Opportunity for Efficacy and Exploratory Clinical Trials (UG3/UH3 - Clinical Trial Required). This funding opportunity is forecasted and is not currently open for application. The purpose of this program is to support research that evaluates exploratory and efficacy clinical trials in areas aligned with the NINDS mission and research priorities. Projects may examine drugs, biologics, devices, surgical approaches, behavioral interventions, and rehabilitation therapies intended to address neurological disorders. The NINDS seeks to provide researchers with the opportunity to pursue scientifically rigorous clinical studies that can yield insights into interventions for neurological conditions. By supporting exploratory and efficacy phases, this program aims to advance promising therapies from preliminary evidence to clinical validation. Applications will be evaluated for their relevance to the mission of NINDS, scientific rigor, and potential impact on neurological health outcomes. The cooperative agreement mechanism (UG3/UH3) will be used for this program. This mechanism typically involves phased support, beginning with milestone-driven exploratory work under the UG3 phase, and contingent on success, continuing into the UH3 efficacy trial stage. Specifics on allowable spending are not yet provided in the forecast but will follow NIH policies for cooperative agreements, covering costs necessary to conduct clinical trials such as personnel, patient care, equipment, and data collection. As this is a forecasted notice, funding amounts including award ceiling, award floor, and total program funding remain unspecified. Eligibility for this funding is broad. Applicants may include state governments, county governments, city or township governments, special district governments, independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations with or without 501(c)(3) status, for-profit organizations (both small businesses and other for-profits), federally recognized and other Native American tribal governments and organizations, public housing authorities, U.S. territories and possessions, regional organizations, faith-based and community-based organizations, eligible federal government agencies, and non-domestic entities such as foreign institutions. The wide eligibility structure reflects NIH’s intent to attract diverse expertise and capacity to conduct neurological clinical research. The forecast outlines important expected dates for applicants. The anticipated posting date for the full Notice of Funding Opportunity is November 12, 2025. The estimated application due date is February 10, 2026. The estimated award date is November 1, 2026, with project start dates expected around December 1, 2026. These dates provide a framework for potential applicants to begin preparing proposals and collaborations in advance. At this stage, no pre-application requirements such as letters of intent or concept papers are listed. Applications are not being solicited at this time. The NIH has emphasized that this advance notice is intended to give prospective applicants time to form meaningful collaborations and to begin planning competitive, responsive projects. Interested investigators are encouraged to review NINDS mission priorities at the NINDS website to ensure alignment of proposed projects. Questions regarding this funding opportunity can be directed to Jeremy Brown, MD, via the dedicated program email Exploratory_Efficacy_Trials@ninds.nih.gov.