Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)

The National Institute of Neurological Disorders and Stroke (NINDS) is forecasting a future funding opportunity to support research that uses data from intermediate‑size expanded‑access protocols for ALS. Eligible applicants are clinical trial sites already participating in phase 2/3 or phase 3 ALS efficacy trials, partnered with a U.S. small‑business sponsor that holds the IND for the investigational drug/biologic. The goal is to generate safety, biomarker, outcome, and patient‑experience data that can inform ALS research and potentially support future marketing applications. This is a Cooperative Agreement (U01) under the NIH Extramural Research Programs in the Neurosciences and Neurological Disorders (CFDA 93.853). No applications are being solicited yet; the notice is intended to give prospective applicants lead time to develop responsive projects. • Funding mechanism: NIH Cooperative Agreement (U01) – “grant‑like” award with substantial NIH involvement. • Target applicants: U.S. clinical trial sites in phase 2/3 or phase 3 ALS trials, partnered with a U.S. small‑business sponsor (the IND holder). • Research focus: Collect and analyze data from expanded‑access protocols (access to investigational ALS drug/biologic) to study biomarkers, safety, outcomes, and patient‑reported experiences. • Anticipated timeline: Forecast posting Sep 2026 → Synopsis posting Mar 2027 → Application response deadline May 2027 → Award Apr 2028 → Project start Apr 2028. • Eligibility restrictions: No foreign organizations or foreign components of U.S. entities; must meet NIH small‑business definition.