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

ALS Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) is sponsored by National Institutes of Health (NIH). This opportunity supports mission-aligned projects and measurable outcomes.

Opportunity Listing - Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) Simpler. Grants. gov uses Login.

gov to verify your identity and manage your account securely. You don't need a separate username or password for this site. Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) Agency: National Institutes of Health 93.

853 -- Extramural Research Programs in the Neurosciences and Neurological Disorders Open Open opportunity Last Updated: May 13, 2026 View version history on Grants.

gov 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.

For-profit organizations other than small businesses Federally recognized Native American tribal governments Special district governments Public and Indian housing authorities City or township governments Private institutions of higher education Independent school districts Public and state institutions of higher education Other Native American tribal organizations Nonprofits non-higher education without 501(c)(3) Nonprofits non-higher education with 501(c)(3) 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.

Grantor contact information NINDSALSMailbox@mail. nih. gov NINDSALSMailbox@mail.

nih. gov NINDSALSMailbox@mail. nih.

gov File name Description Last updated RFA-NS-26-001-Full-Announcement. html RFA-NS-26-001-Full-Announcement. html Link to additional information Closing: November 10, 2026 Funding opportunity number : Cost sharing or matching requirement : Funding instrument type : Opportunity Category Explanation : Category of Funding Activity : Your account requires additional identity verification.