DoW Amyotrophic Lateral Sclerosis Research Program, Therapeutic Development Award
About
Summary: The fiscal year 2026 (FY26) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA) supports research ranging from preclinical validation of therapeutic leads through U. S. Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to be empirical in nature and product-driven. Applicants with limited amyotrophic lateral sclerosis (ALS) experience are strongly encouraged to include collaborators with substantial experience in the relevant ALS model systems, endpoints and pathophysiology. Applications supported by this award must begin with lead compounds in hand and must already demonstrate proof-of-concept efficacy data in at least one appropriate preclinical model system of ALS, including whole-animal and cellular model systems. Distinctive Features: Mechanism-specific, predictive/cohort-selective, target engagement and pharmacodynamic biomarker development, in parallel to the main therapeutic effort, is a critical component of the FY26 ALSRP Therapeutic Development Award. If appropriate mechanism-specific biomarkers are already available or currently in development, how the existing biomarkers will improve trial design, patient selection, and efficiency or interpretation of the proposed ALS therapeutic approach must be apparent in the application. Development of biomarkers for the purposes of diagnosis, prognosis, or measurement of general disease progression without cons.
The DoW Amyotrophic Lateral Sclerosis Research Program Therapeutic Development Award supports researchers and organizations advancing novel ALS treatments from preclinical validation through FDA Investigational New Drug (IND)-enabling studies. This grant is designed for research teams working to translate promising lead compounds into clinical-stage therapeutics for amyotrophic lateral sclerosis. Researchers with limited ALS experience are encouraged to apply with collaborators who have substantial expertise in ALS model systems and pathophysiology. The program emphasizes empirical, product-driven research that builds on existing proof-of-concept efficacy data in appropriate preclinical ALS models. A critical distinctive feature of the FY26 award cycle is the requirement for parallel development of mechanism-specific, predictive biomarkers alongside therapeutic development. These biomarkers should support target engagement assessment, patient selection, and trial design optimization. If applicable biomarkers already exist, applicants must clearly demonstrate how existing tools will enhance patient stratification, trial efficiency, and result interpretation. This award represents a significant opportunity for research organizations ready to accelerate ALS therapeutic candidates toward clinical translation and regulatory approval.
Funding Facts
● Applications openDeadline
September 30, 2026
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Amount varies—contact program for details
Deadline
2026-09-30
Grant Type
federal
Application Cycle
Annual cycle (FY26 deadline: September 30, 2026)
Best For
Research organizations developing ALS therapeutics from preclinical to IND-enabling stages; teams with lead compounds and proof-of-concept data
Frequently Asked Questions
Who is eligible for DoW Amyotrophic Lateral Sclerosis Research Program, Therapeutic Development Award?
Eligibility criteria are not specified in the available program information. For detailed eligibility requirements, organization types accepted, and researcher qualifications, please visit the official Department of War (DoW) ALSRP website or contact the program directly.
How much funding does DoW Amyotrophic Lateral Sclerosis Research Program, Therapeutic Development Award provide?
Specific funding amounts are not listed in the available program details. Award amounts may vary based on project scope, research phase, and program cycle. Contact the official program administrators or visit the DoW ALSRP website for current funding levels and budget guidelines.
How do I apply for DoW Amyotrophic Lateral Sclerosis Research Program, Therapeutic Development Award?
Applications for the FY26 cycle are due by September 30, 2026. The application process typically requires detailed research proposals demonstrating existing proof-of-concept efficacy data, preclinical model validation, and integrated biomarker development strategies. For specific submission procedures, required documentation, and portal access, visit the official DoW ALSRP program website.
What can DoW Amyotrophic Lateral Sclerosis Research Program, Therapeutic Development Award funding be used for?
Funding supports research spanning preclinical validation of therapeutic leads through FDA IND-enabling studies for ALS treatments. Eligible uses include empirical, product-driven research with existing lead compounds, proof-of-concept studies in animal and cellular ALS models, and parallel development of mechanism-specific biomarkers for target engagement, patient selection, and pharmacodynamic assessment. Research must demonstrate clear therapeutic efficacy in appropriate preclinical model systems before funding.
Last updated: July 5, 2026