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

Agency: National Institutes of Health

Assistance Listings: 93.853 -- Extramural Research Programs in the Neurosciences and Neurological Disorders

Last Updated: September 23, 2026

Description

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.

Eligibility

Eligible applicants

Nonprofit

  • Nonprofits non-higher education without 501(c)(3)
  • Nonprofits non-higher education with 501(c)(3)
  • Other Native American tribal organizations

Education

  • Private institutions of higher education
  • Public and state institutions of higher education

Government

  • State governments
  • Federally recognized Native American tribal governments
  • County governments
  • City or township governments
  • Special district governments

Miscellaneous

  • Other

Business

  • For-profit organizations other than small businesses
  • Small businesses

Additional information

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. based 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.

Grantor contact information

Description

ALS Program Please contact via email.

Email

NINDSALSMailbox@mail.nih.gov

NINDSALSMailbox@mail.nih.gov

Documents

No documents are currently available.

Link to additional information

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Forecasted

Estimated Post Date:

March 1, 2027

Estimated Application Due Date:

May 25, 2027

Estimated Due Date Description:

Not available

Estimated Award Date:

April 1, 2028

Estimated Project Start Date:

April 1, 2028

Fiscal Year:

2028

Application process

This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates.

Award

$--

Program Funding

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Expected awards

$--

Award Minimum

$--

Award Maximum

Funding opportunity number:

RFA-NS-28-009

Cost sharing or matching requirement:

No

Funding instrument type:

Cooperative agreement

Opportunity Category:

Discretionary

Opportunity Category Explanation:

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Category of Funding Activity:

Health

Category Explanation:

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History

Version:

1

Forecast posted date:

September 23, 2026

Archive date:

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