Forecast

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

From	National Institutes of Health
Who can apply	state governments, counties, cities and townships, special districts (water, fire, parks, etc.), public colleges and universities, federally recognized tribes and 7 more types
Eligibility notes	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 establish substantial evidence of effectiveness in support of a marketing application) supported by a U.S.…
How much	Amount not stated
Deadline	Tue, May 25, 2027 (estimated) (213 days left)
Category	Health
Type	Cooperative agreement
Opportunity #	RFA-NS-28-009
Assistance listing	93.853
Posted	Wed, Sep 23, 2026

Heads-up: Forecast: not open yet. Dates and amounts are the agency's estimates.

Open the official posting

From the notice

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting the conduct of scientific research utilizing data from intermediate-size patient population expanded access protocols for ALS ("intermediate expanded access protocol for ALS", see Expanded Access Categories for Drugs (Including Biologics)). Eligible intermediate expanded access protocols for ALS should: 1) provide access to an investigational drug or biological product for people with ALS, and 2) generate data to support research on the prevention, diagnosis, mitigation, treatment, or cure of ALS. The scientific research goal(s) informed by these data could include the investigational drug's or biological product's effect on biomarkers related to the pathophysiology of ALS or target engagement, the collection of safety or outcome information, such as survival or other significant medical events (e.g., hospitalization or need for ventilatory support), or patient experience data that are not specifically tied to assessing efficacy. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop responsive projects.

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