The Fiscal Year 2025 (FY25) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA), offered through the Department of Defense’s (DoD) Defense Health Program, is managed by the Congressionally Directed Medical Research Programs (CDMRP). The CDMRP operates under the U.S. Army Medical Research and Development Command (USAMRDC) with delegated authority under U.S. Code Title 10, Section 4001. Since its inception in 2007, the ALSRP has received a cumulative appropriation of $269.4 million through FY24. For FY25, Congress has allocated $40 million to continue support for high-impact research with the potential to significantly improve the treatment and management of Amyotrophic Lateral Sclerosis (ALS).

The purpose of the Therapeutic Development Award is to fund research that supports the advancement of lead therapeutic compounds from preclinical validation through Investigational New Drug (IND)-enabling studies. Eligible projects must begin with proven lead compounds and show preliminary efficacy in at least one relevant ALS model. The award does not support therapeutics that have already received IND approval. Applications must demonstrate a strong empirical, product-driven rationale and should integrate biomarker development for cohort selectivity, target engagement, or pharmacodynamics. Projects focused solely on biomarker discovery or disease progression without therapeutic alignment are not eligible.

The award provides funding up to $1.5 million in direct costs over a maximum of three years. Approximately $9.8 million is expected to be awarded to support four projects. Eligible applicants include a wide range of extramural and intramural organizations, both domestic and international, including academic institutions, nonprofit organizations, for-profit entities, and federal government agencies other than the DoD. Independent investigators at all career stages may apply, with no restrictions based on nationality or citizenship. Clinical trials are not allowed under this mechanism, though use of pre-existing human biospecimens for exploratory studies is encouraged.

Applicants must complete a two-step submission process beginning with a pre-application due by June 6, 2025, through the eBRAP portal. Full applications, by invitation only, are due by August 27, 2025, via Grants.gov. Additional key dates include the invitation to submit (July 10, 2025), end of the verification period (September 3, 2025), peer review (October 2025), and programmatic review (December 2025). Awards will be announced by September 30, 2026, and will be funded with FY25 appropriations that expire on September 30, 2031.

The application must follow strict formatting and content requirements including submission of a preproposal narrative, project narrative, supporting documents, biomarker development plans, transition plan, impact statement, and if applicable, an animal research plan. Evaluation criteria encompass therapeutic rationale, biomarker strategy, research feasibility, clinical impact, and transition readiness. Compliance reviews, peer reviews, and programmatic reviews determine which projects are recommended for funding. Only the USAMRAA Grants Officer may authorize awards, and awardees must comply with all administrative and national policy requirements.

For questions, technical assistance is available through the eBRAP Help Desk at help@eBRAP.org (301-682-5507) and the Grants.gov Contact Center at support@grants.gov (800-518-4726 or 1-606-545-5035 internationally).