Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
ID: 360400Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH) is announcing a funding opportunity for research on amyotrophic lateral sclerosis (ALS) through the "Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)" grant. This initiative aims to support clinical trial sites that participate in phase 2/3 or phase 3 efficacy trials for investigational drugs or biological products targeting ALS, specifically for patients who are not eligible for ongoing clinical trials. Given the urgent need for effective treatments for ALS, which affects over 32,000 individuals in the U.S. and has limited existing therapeutic options, this funding will facilitate research that utilizes data from expanded access protocols to improve patient outcomes. The estimated total program funding is $40 million, with four awards expected, and interested applicants can reach out to Dr. Amy Tsou at amy.tsou@nih.gov or (240) 987-2815 for further information. The application process is anticipated to open with a synopsis posted on October 29, 2025, and the estimated award date is September 1, 2026.

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