Opportunity Overview
<p><strong>Summary: </strong>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.</p><p><br></p><p>Applications must address one of the following focus areas:</p><p><br></p><p>· <strong>Biomarker-Driven Interventions: </strong>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.</p><p>· <strong>Clinical Care: </strong>Improving aspects of clinical care and symptom management for ALS.</p><p><br></p><p><strong>Distinctive Features: </strong>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.</p><p><br></p><p>Projects proposing a therapeutic intervention (drug, biologic, and/or device) must incorporate biomarkers specific to the intervention into the trial design.</p><p><br></p><p>All pre-applications and applications <u>are required</u> to incorporate community collaboration, as described in Section 3.2.2, to optimize research impact.</p><p><br></p><p>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.</p>
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| Issuing agency | Defense Health Agency Contracting Activity - DHACA |
|---|---|
| Country | United States |
| Category | Research and Studies |
| NAICS | 12.420 |
| Published | May 04, 2026 |
| Procurement stage | Request for Proposal (RFP) |
| Response due | September 30, 2026 |
| Status | Open — accepting responses |
| Official source | View original notice |
| Last verified | August 10, 2026 |
Source: U.S. Government (Grants.gov) — public domain. Not affiliated with or endorsed by the United States Government.
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