DOD Amyotrophic Lateral Sclerosis, Therapeutic Development Award

The Department of Defense (DOD) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA) for Fiscal Year 2025 is part of the Defense Health Program under the Congressionally Directed Medical Research Programs (CDMRP). Administered by the U.S. Army Medical Research and Development Command (USAMRDC) and the U.S. Army Medical Research Acquisition Activity (USAMRAA), this program aims to advance research that improves the health and care of military service members, veterans, their families, and the broader population affected by ALS. Since its inception in 2007, the ALSRP has received appropriations totaling $269.4 million, with an additional $40 million allocated for FY25. The Therapeutic Development Award supports empirical, product-driven research from the preclinical validation of therapeutic leads to Investigational New Drug (IND)-enabling studies. All proposed studies must begin with identified lead compounds that already have proof-of-concept efficacy data in at least one preclinical ALS model. The award strongly emphasizes the development and integration of mechanism-specific, predictive, target engagement, and pharmacodynamic biomarkers. Biomarker development solely for diagnosis, prognosis, or general disease progression, unrelated to therapeutic development, will not be supported. Applicants with limited ALS experience must collaborate with experts in relevant ALS model systems and pathophysiology. Projects with candidate therapeutics that already have IND approval are ineligible. The award provides up to $2 million in total costs over a maximum of three years. Approximately $10.5 million is expected to be available to fund around five awards. Clinical trials are not allowed under this mechanism, though studies using preexisting, de-identified human specimens from well-characterized cohorts are encouraged. Awarded research must have significant potential for transitioning to clinical applications and align with military relevance, given the higher incidence of ALS among veterans. Eligible applicants include both extramural and intramural organizations—academic institutions, biotechnology companies, non-profit and for-profit organizations, federal agencies (excluding DOD for extramural), and public or private entities. There are no restrictions on the citizenship or nationality of the principal investigator, who must be an independent investigator at any career level. The application process requires a two-step submission through eBRAP and Grants.gov (or eBRAP for intramural applicants). The pre-application is due by June 6, 2025, with invitations for full applications issued by July 10, 2025. Full applications are due by August 27, 2025. Peer review will occur in October 2025, followed by programmatic review in December 2025. Final awards will be issued no later than September 30, 2026, with all funds expiring by September 30, 2031. Evaluation criteria for selection include scientific merit, feasibility, biomarker strategy, transition readiness, and potential clinical impact. Required components for submission include technical and lay abstracts, a detailed project narrative, biomarker statement, impact and transition plans, and applicable compliance forms. Contact support includes the eBRAP Help Desk (help@eBRAP.org, 301-682-5507) and Grants.gov Contact Center (support@grants.gov, 800-518-4726).