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

This NIH Notice of Funding Opportunity (NOFO) invites investigator‑initiated clinical trials that address neurological diseases across the lifespan. Applicants may propose early‑phase exploratory studies (UG3) or later‑phase confirmatory/ comparative‑effectiveness trials (UH3) involving small molecules, biologics, devices, surgical, behavioral, diet‑based, or rehabilitation therapies. Funding is provided as a cooperative agreement (UG3/UH3) with an initial feasibility phase (UG3) followed by a continuation phase (UH3) contingent on meeting predefined milestones. The award supports all aspects of trial design, regulatory compliance (e.g., IND/IDE), data management, safety monitoring (DSMB), and required reporting (annual RPPR). Eligible entities include a broad range of U.S. and foreign organizations (government, for‑profit, nonprofit, academic, tribal, etc.). Applications open September 9 2026 and must be submitted by March 9 2029. • Target area: Neurological disease clinical research (basic, translational, or therapeutic). • Funding instrument: UG3/UH3 Cooperative Agreement (activity codes UG3, UH3). • Eligible applicants: Wide spectrum of U.S. and foreign entities (state, local, tribal, private, nonprofit, etc.). • Key dates: Open Sept 9 2026; due Mar 9 2029; anticipated award Nov 1 2026; earliest start July 2027. • Required deliverables: Data Management & Sharing Plan, annual RPPR, milestone reports, final close‑out documentation. • Contact: Scientific queries via [email protected]; technical submission support via eRA Service Desk.