DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award

The FY26 Amyotrophic Lateral Sclerosis Research Program Pilot Clinical Trial Award is administered through the Defense Health Agency Contracting Activity under the Congressionally Directed Medical Research Programs. The program is designed to accelerate translational and clinical research for amyotrophic lateral sclerosis by supporting pilot clinical trials with the potential to improve treatment approaches, symptom management, and clinical care outcomes for individuals living with ALS. The program vision is to improve outcomes and find cures for people with ALS, while the mission is to fund and accelerate research that translates science into effective ALS treatments. Since its establishment in 2007, the ALS Research Program has received more than $309 million in appropriations, with the FY26 appropriation totaling $40 million. The Pilot Clinical Trial Award specifically supports rapid implementation of clinical trials ranging from Phase 1 through small-scale Phase 2 studies. Applications must align with one of two focus areas: Biomarker-Driven Interventions or Clinical Care. Biomarker-Driven Interventions projects must include disease-modifying therapeutic approaches with mechanism-specific biomarkers integrated directly into the trial design. These biomarkers are intended to demonstrate target engagement, predict therapeutic response, and improve the design of future later-stage trials. Clinical Care projects are intended to improve symptom management and multidisciplinary clinical care for ALS patients and are expected to produce near-term impact on quality of life and patient care. All proposed projects must qualify as clinical trials; preclinical research is specifically excluded from eligibility under this opportunity. The funding opportunity places substantial emphasis on community collaboration and patient-centered research planning. Every pre-application and full application must include a meaningful collaboration with people living with ALS, caregivers, family members, community organizations, or advisory boards. These collaborators are expected to contribute throughout project planning, implementation, evaluation, and dissemination activities rather than serving in only ceremonial or occasional advisory roles. Applicants are encouraged to develop partnerships that improve trial accessibility, recruitment, retention, and responsiveness to patient needs. The program also prioritizes research with significance for military service members, veterans, and their families due to evidence showing increased ALS incidence among veterans. Approximately $5.6 million is expected to be available to support approximately two awards. Individual applications may request up to $2.8 million in total costs over a maximum three-year performance period. Indirect costs are permitted according to negotiated institutional rates, and subaward indirect costs must be included within the primary award direct cost structure. Allowable costs include travel supporting multi-institutional collaboration, investigator attendance at up to two scientific meetings annually for dissemination purposes, and participant support expenses such as travel, lodging, caregiving assistance, parking, and equipment needed for participation. Costs beyond the specified travel limits are not allowable. Cost sharing is not required. Eligibility is broad and includes foreign and domestic organizations, nonprofit organizations, for-profit organizations, public and private institutions, and intramural Department of War organizations. Independent investigators affiliated with eligible organizations may serve as Principal Investigators regardless of nationality or citizenship status. Principal Investigators may participate on no more than three FY26 ALS Research Program applications across all award mechanisms. Applications involving regulated products such as investigational drugs or devices must include evidence that Investigational New Drug or Investigational Device Exemption submissions were filed with the appropriate regulatory authority prior to the application submission deadline. Applicants must also include a detailed Regulatory Strategy and a Post-Award Transition Plan describing future development and commercialization pathways. The submission process involves two phases. A mandatory pre-application must be submitted through eBRAP, followed by an invitation-only full application submitted either through Grants.gov for extramural organizations or eBRAP for intramural organizations. Required components include a project narrative, technical and lay abstracts, statement of work, recruitment and safety plans, regulatory strategy documentation, personnel and organizational plans, community collaboration plan, impact statement, and transition plan. Biomarker-Driven Intervention applications must additionally include a dedicated biomarker statement. Peer review evaluates clinical impact, feasibility, statistical design, recruitment strategy, biomarker implementation, ethical considerations, regulatory readiness, transition planning, and community integration. Programmatic review additionally evaluates alignment with ALS Research Program priorities and portfolio composition. The FY26 funding opportunity uses a recurring annual structure. Pre-applications are due by June 24, 2026, and invited full applications are due September 30, 2026. Invitations to submit full applications are expected on August 3, 2026. Peer review is scheduled for November 2026, followed by programmatic review in January 2027. Awards are expected to be made no later than September 30, 2027, with funded clinical trials required to begin within 12 months of the award date, or within 18 months for FDA-regulated studies. Applicant support is available through the eBRAP Help Desk at help@eBRAP.org and 301-682-5507, and through the Grants.gov Support Center at support@grants.gov and 800-518-4726.

Demonstrate strong biomarker integration for therapeutic studies; clearly document community collaboration throughout the research lifecycle; provide robust recruitment and retention mitigation plans; ensure regulatory submissions such as IND or IDE are completed before the application deadline; emphasize clinical impact for ALS patients and relevance to veterans and military families.