FDA Rare Neurodegenerative Disease Grants Program

The FDA Rare Neurodegenerative Disease Grants Program sits under the Office of Orphan Products Development and was established by the ACT for ALS Act in 2021. It began awarding grants in 2022 and supports clinical trial work on interventions intended to prevent, diagnose, mitigate, treat, or cure ALS and other rare neurodegenerative diseases in adults and children. The most recent notice had a receipt date of 21 October 2025, and no confirmed next-cycle date is available in the current sources. The program is treated as annual, but applicants need to watch for the next FDA notice rather than assume a fixed open window. It is open to foreign or domestic, public or private, for-profit or nonprofit entities, while federal agencies are excluded. The available material does not disclose a budget or award ceiling. This route is strongest for teams that can put a clear rare-neurodegenerative disease question into a clinical trial format with a plausible safety or efficacy endpoint. Because the program can award both grants and contracts, applicants should be ready for a more structured federal funding relationship than a standard investigator-initiated grant. The best fit is work that speaks directly to the unmet needs of ALS or related conditions and can be translated into evidence that matters for patients, clinicians, and regulators.

Each grant below is a distinct funding opportunity with its own eligibility, scope, and deliverables.