NIH RFA · NINDS · U01
RFA-NS-26-001: Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Reviewed by Dr. Meng ZhaoLast reviewed October 16, 2026Data refreshed October 16, 2026Editorial standards
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.
- NOFO number
- RFA-NS-26-001
- Type
- RFA
- Activity code
- U01
- Primary institute
- NINDS · National Institute of Neurological Disorders and Stroke
- Clinical trials
- Required
- Posted
- May 4, 2026
- Opens
- May 4, 2026
- Expires
- Nov 11, 2026
RFA-NS-26-001 due dates
1 application due date remains before the NOFO expires. Dates marked * are NIH standard due dates. Check the related notices below for changes NIH made after posting.
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
|---|---|---|---|---|---|
| June 08, 2026 | June 08, 2026 | Not Applicable | July 2026 | August 2026 | September 2026 |
| November 10, 2026 | November 10, 2026 | Not Applicable | March 2027 | May 2027 | July 2027 |
Projects funded under RFA-NS-26-001
NIH RePORTER lists 1 project funded under RFA-NS-26-001 in FY2022–FY2026, with $8.3M in award dollars. Counts include each project's later non-competing years, which keep the original NOFO number.
Projects funded
1
Distinct projects, FY2022–FY2026
New awards
1
Type 1 (new project) award records
NIH funding
$8.3M
Award dollars under RFA-NS-26-001, FY2022–FY2026
Funding by fiscal year
| Fiscal year | Award records | New awards | Funding |
|---|---|---|---|
| FY2022 | 0 | 0 | $0 |
| FY2023 | 0 | 0 | $0 |
| FY2024 | 0 | 0 | $0 |
| FY2025 | 0 | 0 | $0 |
| FY2026 | 1 | 1 | $8.3M |
Institutions with the most funding
- Massachusetts General Hospital$8.3M · 1 project
Funding institutes
- NINDS$8.3M · 1
Activity codes funded
- U011 record
Most recent new awards
- An Intermediate-Size Expanded Access Protocol (EAP) for NUZ-001 in People with Amyotrophic Lateral Sclerosis (NUZ-001 EAP) (opens NIH RePORTER)
Massachusetts General Hospital · 1U01NS153995-01 · NINDS · Notice Aug 28, 2026
$8.3MU01
FY2026 closed on September 30, 2026, but NIH keeps posting that year's awards to RePORTER for several weeks. FY2026 figures reflect records available on October 16, 2026 and may rise slightly at the next refresh.
Participating institutes
3 NIH institutes and offices take applications under RFA-NS-26-001. Contact the program officer at the institute that fits your research before applying.
- NINDS · National Institute of Neurological Disorders and Stroke
- OD · NIH Office of the Director
- none
Related notices
NIH lists no related notices for RFA-NS-26-001 yet.
Award terms
- Application types allowed
- New Renewal Resubmission The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
- Award budget
- Application budgets need to reflect the actual needs of the proposed project.
- Project period
- The scope of the proposed project should determine the project period. The maximum project period is 4 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
- Funds available and number of awards
- NINDS intends to commit up to 40,000,000 per fiscal year to fund 4 new awards per year for the duration of this RFA. This estimate is contingent upon NIH appropriations and a sufficient number of meritorious applications.
Summarized from the NOFO text; the full NOFO governs eligibility, budget, and review.
Related NOFOs
- Reissue of RFA-NS-25-024.
Other open NOFOs for U01
- PAR-25-149Limited Competition: Renewal of Existing NINDS-Supported Clinical Trial Cooperative Agreement Awards (U01 - Clinical Trials Required)NINDS · next due Nov 5, 2026
- RFA-NS-27-015BRAIN Initiative Connectivity across Scales (BRAIN CONNECTS): Specialized Projects for Scalable Technologies (U01 Clinical Trial Not Allowed)NINDS · next due Feb 8, 2027
- PAR-25-327Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders (U01 - Clinical Trial Optional)NINDS · next due Feb 9, 2027
- RFA-AI-27-014Development of Candidate Medical Countermeasures (MCMs) and Technologies Against Radiological/Nuclear or Chemical Threats (U01 Clinical Trial Not Allowed)NIAID · next due Nov 9, 2026
- PAR-26-116Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional)OD · next due Feb 5, 2027
- RFA-MH-26-140BRAIN Initiative: Brain Behavior Quantification and Synchronization- Next Generation Sensor Technology Development (U01 Clinical Trial Optional)NIMH · next due Jun 15, 2027
About this page
GotGrant gathers the NOFO, its participation and change notices, and its NOSIs from the NIH Guide for Grants and Contracts, and counts funded projects from NIH RePORTER by the opportunity number each award was made under. Data refreshed October 16, 2026; the NIH Guide is the authoritative source. See our data methodology.