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OpenU01NINDSClinical trial: Required

Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)

National Institute of Neurological Disorders and Stroke (NINDS) · NIH Institute/Center · RFA-NS-26-001

Source: Grants.gov · View original posting ↗

Award
$40M total
Deadline
Nov 10, 2026
Letter of intent
Mechanism
U01
Duration
Expected awards
4
Funding cycle
One-time
Open date
May 4, 2026
Total funding
$40M total
Clinical trial
Required
Established investigatorGovernmentSmall businessHigher educationNonprofitForeign entities

Research areas

Biomarkers & diagnosticsTherapeutics & drug discoveryClinical trialsPrevention & risk factors

Auto-classified from the title and description (keyword-based) — may be imperfect.

Description

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.