§ Federal grant opportunity · RFA-NS-26-001
Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
National Institutes of Health is accepting applications for Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required). The deadline is November 10, 2026 and the published award range is Award amount not published.
Key facts
- Funder
- National Institutes of Health
- Application deadline
- November 10, 2026
- Award range
- Award amount not published
- Eligibility
- 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.
- Geography
- United States
- Focus areas
- Health
- Opportunity number
- RFA-NS-26-001
Program overview
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.
How to apply
- Confirm your organization meets the eligibility criteria above.
- Read the full funding opportunity announcement from National Institutes of Health.
- Draft your narrative against the funder's stated priorities and review criteria.
- Submit before November 10, 2026, allowing time for registration and validation.
Related grant opportunities
- Advanced Development and Validation of Emerging Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed)
- Early-Stage Innovative Technology Development for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed)
- ROSES25: C.4 Planetary Science Enabling Facilities
- DoW Spinal Cord Injury, Clinical Translation Research Award
- DoW Spinal Cord Injury, Translational Research Award
Find every grant your organization qualifies for
Mavenly scores this opportunity against your mission, geography, and funding history — then drafts the proposal with you and tracks the deadline through submission and reporting.