Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
This NIH U01 grant funds research using expanded-access data for investigational drugs to help intermediate-size populations of ALS patients who are not eligible for ongoing clinical trials; a clin…
- Deadline
- Nov 10, 2026
- Posted
- May 4, 2026
- Award amount
- Amount not specified
- Focus areas
- Health
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We’ll email you before Nov 10, 2026 so you have time to apply.
In plain English
This NIH U01 grant funds research using expanded-access data for investigational drugs to help intermediate-size populations of ALS patients who are not eligible for ongoing clinical trials; a clinical trial is required. Eligibility is narrow: applicants must be clinical trial sites participating in a phase 2/3 or phase 3 trial sponsored by a small business that is the FDA-designated sponsor of the relevant drug. Foreign organizations and foreign components are not eligible. No award amounts are listed. This is a highly specialized opportunity tied to an existing small-business-sponsored ALS drug trial, not a general grant.
AI-generated summary to help you decide quickly — verify the official eligibility rules before applying.
Who can apply
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Eligible applicants must be clinical trial sites that participate in a phase 2/3 or phase 3 efficacy clinical trial (designed to provide pivotal data to support a marketing application) supported by a small business concern that is the FDA-designated sponsor of a drug or biological product which is the subject of an IND under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) to prevent, diagnose, mitigate, treat, or cure ALS. The definition of a small business concern can be found in section 3(a) of the Small Business Act (15 U.S.C. 632(a)).Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
About this grant
The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) for investigational drugs or biological products as described in section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb). These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not eligible for ongoing clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of ALS.
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