DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award

Key Facts

Status: Forecasted

Posted date: May 4, 2026

Archive date: October 30, 2026

Close date: September 30, 2026

Opportunity ID: 362195

Opportunity number: HT942526ALSRPPCTA

Opportunity category: Discretionary

Agency name: Dept. of the Army -- USAMRAA

Agency code: DOD-AMRAA

Award floor: $0

Award ceiling: $0

Cost sharing required: No

Funding Instrument Types
  • Grant
Category of Funding Activity
  • Science and Technology and other Research and Development
Eligible Applicants
  • Unrestricted
Tools
Categories (use these for quoted searches)
  • agency_code:dod_amraa
  • category_of_funding_activity:science_and_technology_and_other_research_and_development
  • cost_sharing_or_matching_requirement:false
  • eligible_applicants:unrestricted
  • funding_instrument_type:grant
  • opportunity_category:discretionary
  • status:forecasted
Description

Summary: The fiscal year 2026 (FY26) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award (PCTA) supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of amyotrophic lateral sclerosis (ALS). Projects may range from phase 1 to small-scale phase 2 trials.Applications must address one of the following focus areas:· Biomarker-Driven Interventions: Disease-modifying interventions, with mechanism-specific biomarkers to predict which clinical trial participants are likely to respond, demonstrate target engagement, and effects on the intended biological pathway.· Clinical Care: Improving aspects of clinical care and symptom management for ALS.Distinctive Features: Funding from this award mechanism must support a clinical trial. The clinical trial should begin no later than 12 months after the award date or 18 months for U.S. Food and Drug Administration (FDA)-regulated studies.Projects proposing a therapeutic intervention (drug, biologic, and/or device) must incorporate biomarkers specific to the intervention into the trial design.All pre-applications and applications are required to incorporate community collaboration, as described in Section 3.2.2, to optimize research impact.Applications must include a detailed Regulatory Strategy plan that outlines the approach for obtaining regulatory approvals, if required, specifically for the funded portion of the study. In addition, applications must provide a separate Transition Plan that describes how the outcomes of the study will be advanced to the next phase of development, beyond the scope of the funded work.

DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award
Summary: The fiscal year 2026 (FY26) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award (PCTA) supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of amyotrophic lateral sclerosis (ALS). Projects may range from phase 1 to small-scale phase 2 trials.Applications must address one of the following focus areas:· Biomarker-Driven Interventions: Disease-modifying interventions, with mechanism-specific biomarkers to predict which clinical trial participants are likely to respond, demonstrate target engagement, and effects on the intended biological pathway.· Clinical Care: Improving aspects of clinical care and symptom management for ALS.Distinctive Features: Funding from this award mechanism must support a clinical trial. The clinical trial should begin no later than 12 months after the award date or 18 months for U.S. Food and Drug Administration (FDA)-regulated studies.Projects proposing a therapeutic intervention (drug, biologic, and/or device) must incorporate biomarkers specific to the intervention into the trial design.All pre-applications and applications are required to incorporate community collaboration, as described in Section 3.2.2, to optimize research impact.Applications must include a detailed Regulatory Strategy plan that outlines the approach for obtaining regulatory approvals, if required, specifically for the funded portion of the study. In addition, applications must provide a separate Transition Plan that describes how the outcomes of the study will be advanced to the next phase of development, beyond the scope of the funded work.
[Forecasted] DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award
Forecasted
Dept. of the Army -- USAMRAA
Science and Technology and other Research and Development
Grant
Unrestricted
2026-05-04