DoW Amyotrophic Lateral Sclerosis Research Program, Therapeutic Development Award

The Amyotrophic Lateral Sclerosis Research Program Therapeutic Development Award is a federal funding opportunity administered by the Defense Health Agency Contracting Activity through the Congressionally Directed Medical Research Programs under the Amyotrophic Lateral Sclerosis Research Program. The funding opportunity is identified as HT942526ALSRPTDA and is associated with Assistance Listing Number 12.420. The ALSRP was initiated by Congress in 2007 to support high-impact and scientifically rigorous research related to amyotrophic lateral sclerosis. The fiscal year 2026 vision for the program is to improve outcomes and find cures for people with ALS, while its mission is to accelerate research that translates scientific discoveries into effective ALS therapies. The Therapeutic Development Award mechanism specifically supports projects that advance candidate therapeutics from preclinical validation through Investigational New Drug enabling studies. The opportunity is intended for empirical and product-driven projects that already possess lead compounds and proof-of-concept efficacy data in at least one relevant ALS preclinical model. The funding opportunity is designed for therapeutic candidates that are still in the preclinical development pipeline and have not yet received an FDA Investigational New Drug designation. Projects must demonstrate strong preliminary evidence including proof of compound identity and purity, target selectivity, availability of bioactivity assays, and efficacy data in ALS-relevant model systems. Supported activities may include lead optimization, formulation development, pharmacokinetic characterization, toxicology, Good Manufacturing Practice preparation, and absorption, distribution, metabolism, and excretion studies. Biomarker development is considered a required and central feature of all applications. The program strongly emphasizes mechanism-specific predictive biomarkers, target engagement biomarkers, and pharmacodynamic biomarkers that can improve patient selection, trial interpretation, and therapeutic development efficiency. Biomarker work that is disconnected from therapeutic development, such as biomarkers intended only for diagnosis or prognosis, is not supported under this mechanism. The Department of Defense expects to allocate approximately $12 million to support about six awards, with each award capped at $2 million in total costs for a maximum performance period of three years. Applications may request the full amount even for projects shorter than the maximum performance period. Indirect costs are allowable in accordance with negotiated institutional rates, and collaborating institutions may include their own approved indirect rates. Cost sharing is not required. Funding may support travel related to multi-institutional collaborations and attendance by one investigator at one scientific or technical meeting per year to present findings related to the funded project. The program specifically prohibits requests for additional conference travel beyond the stated limits. Clinical trials are not permitted under this funding opportunity, although use of preexisting de-identified human biospecimens and datasets is encouraged. The solicitation also states that collection of new human specimens is not allowed and that animal studies involving painful research on domestic cats or dogs are prohibited except for military or service animal studies. Eligibility is broad and includes domestic and foreign organizations, nonprofit organizations, for-profit organizations, academic institutions, public entities, and intramural Department of War organizations. Independent investigators affiliated with eligible organizations may serve as Principal Investigators regardless of citizenship or nationality. Applicants with limited ALS expertise are encouraged to collaborate with experienced ALS investigators. Multidisciplinary collaborations involving academia, industry, the Department of War, the Department of Veterans Affairs, and other federal agencies are encouraged because of the program’s emphasis on military relevance and translational impact for service members, veterans, and their families. Projects are expected to address rigorous and reproducible research practices and comply with standards such as ARRIVE, CONSORT, SPIRIT, and STROBE guidelines. The application process uses a required two-step submission system. Applicants must first submit a pre-application through the Electronic Biomedical Research Application Portal. The pre-application includes a three-page preproposal narrative describing the rationale for the candidate therapeutic, clinical impact, and biomarker-driven research strategy. Additional pre-application materials include references, abbreviations, and combined biographical sketches. Only applicants invited after pre-application screening may submit a full application. Extramural applicants submit full applications through Grants.gov, while intramural Department of War organizations submit through eBRAP. The full application package includes a project narrative, supporting documentation, technical abstract, lay abstract, statement of work, biomarker statement, impact statement, transition plan, animal research plan if applicable, representations form, and detailed budget materials. The project narrative has a 12-page limit and must include information about therapeutic rationale, research strategy, transition readiness, clinical impact, biomarker development, and study personnel. Applications undergo a multi-stage review process consisting of compliance review, peer review, and programmatic review. Peer review places the greatest emphasis on research strategy and feasibility, followed by rationale for the candidate therapeutic, transition readiness, clinical impact, and personnel qualifications. Reviewers evaluate the rigor of study design, biomarker strategy, statistical plans, translational feasibility, reproducibility measures, and regulatory readiness. Programmatic review then considers peer review outcomes, programmatic balance, military relevance, and alignment with ALSRP priorities. The funding opportunity specifically notes that the highest-scoring applications are not automatically selected for funding because portfolio considerations and military significance are also considered. Successful applicants can expect notification through eBRAP, followed by award negotiations with the Defense Health Agency Contracting Activity Grants Officer. The fiscal year 2026 Therapeutic Development Award uses a recurring annual funding structure. The pre-application deadline is June 24, 2026, at 5:00 p.m. Eastern Time. Invitations to submit full applications are expected by August 3, 2026, and invited full applications are due September 30, 2026, at 11:59 p.m. Eastern Time. The application verification period closes October 6, 2026. Peer review is expected in November 2026 and programmatic review in January 2027, with awards anticipated by September 30, 2027. Applicants must maintain active registrations in SAM.gov, Grants.gov, and eBRAP prior to submission. Technical support is available through the eBRAP Help Desk at help@eBRAP.org and 301-682-5507, while Grants.gov support is available at support@grants.gov and 800-518-4726. The program announcement emphasizes that applications should not include classified research, duplicate submissions, or clinical trials, and that strict compliance with formatting and submission instructions is required throughout the application process.

Emphasize rigorous preclinical efficacy data with adequate power analysis and ALS-relevant models. Integrate mechanism-specific biomarkers directly into the therapeutic development strategy. Demonstrate translational readiness and IND-enabling potential. Clearly describe regulatory strategy and transition planning for future clinical implementation.