OpenFederal grantOpen to for-profit businessesRFA-NS-26-001

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

National Institutes of HealthCloses Nov 10, 2026(28 days left)

Does this fit your business?

This is an NIH research grant for clinical trial sites running expanded-access studies of investigational ALS drugs, tied to a phase 2/3 or phase 3 efficacy trial sponsored by a small business holding the FDA IND. If you are not such a trial site, do not bother applying, no matter what your industry score says. About 4 awards come from $40 million total; the per-award amount is not published.

Best for
Clinical trial sites already enrolled in a phase 2/3 or phase 3 ALS efficacy trial, Small-business drug sponsors holding the FDA IND for an ALS investigational drug, US-based research institutions running ALS expanded-access programs
Not for
Businesses with no clinical research or ALS drug development work, Organizations outside the US or with foreign components, Applicants not connected to an ongoing ALS clinical trial
Estimated fit by industry, best first
IndustryEstimated fit
Healthcare & BiotechMatches your industry (clinical)
84
Strong Match
Food & BeverageMatches your industry (food)
73
Good Match
Agriculture & FarmingLimit: Nothing in this notice points to agriculture & farming
54
Possible Match
Arts & CultureLimit: Nothing in this notice points to arts & culture
54
Possible Match
Construction & InfrastructureLimit: Nothing in this notice points to construction & infrastructure
54
Possible Match
Education & TrainingLimit: Nothing in this notice points to education & training
54
Possible Match
Show all 15 industries
Estimated fit by industry, best first
IndustryEstimated fit
Energy & Clean TechLimit: Nothing in this notice points to energy & clean tech
54
Possible Match
Environment & ConservationLimit: Nothing in this notice points to environment & conservation
54
Possible Match
Finance & BankingLimit: Nothing in this notice points to finance & banking
54
Possible Match
Housing & Real EstateLimit: Nothing in this notice points to housing & real estate
54
Possible Match
ManufacturingLimit: Nothing in this notice points to manufacturing
54
Possible Match
Retail & E-CommerceLimit: Nothing in this notice points to retail & e-commerce
54
Possible Match
Social Services & NonprofitLimit: Nothing in this notice points to social services & nonprofit
54
Possible Match
Technology & SoftwareLimit: Nothing in this notice points to technology & software
54
Possible Match
Transportation & LogisticsLimit: Nothing in this notice points to transportation & logistics
54
Possible Match

These are our matcher’s estimates for a typical business in each industry. A real match depends on your size, your state and what you need the money for — check your own fit.

What this funds

Money can be used for
Research
Who can apply
Small businesses, For-profit companies, Nonprofits, State and local governments, Colleges and universities, Tribal governments and organizations, Other applicants (see eligibility)

Questions about this grant

When is the application deadline?
November 10, 2026.
How much funding can an applicant receive?
The total program funding is $40,000,000 with about 4 awards expected. The facts do not state a per-award amount, so the maximum an individual applicant can receive is not published.
Who can apply for this grant?
Only clinical trial sites participating in a phase 2/3 or phase 3 ALS efficacy trial sponsored by a small business that holds the FDA IND for the investigational drug. Eligible organizations include higher education institutions, state and local governments, tribes, nonprofits, and small businesses, but the trial-site requirement rules out almost everyone else. US entities only; foreign organizations and foreign components are not allowed.
Can a sole proprietor or single-member LLC apply?
The facts do not say. However, eligibility is limited to clinical trial sites participating in a qualifying ALS efficacy trial, so a sole proprietor or single-member LLC would only qualify if it is such a site.
Can a nonprofit apply?
Yes, nonprofits with or without 501(c)(3) status are listed as eligible applicant types. But a nonprofit must also be a clinical trial site participating in a phase 2/3 or phase 3 ALS efficacy trial sponsored by a small business holding the FDA IND.

Summary

NIH funds research using expanded-access data for investigational ALS drugs. Applicants must be clinical trial sites participating in a phase 2/3 or phase 3 ALS efficacy trial sponsored by a small business holding the FDA IND; US entities only. Funds support research on intermediate-size ALS patient populations not eligible for ongoing trials.

About this grant

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.

Who can apply

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.

Topics and uses of funds

Topics

  • Health
  • Science

Program contact

National Institutes of HealthNINDSALSMailbox@mail.nih.gov301-402-2541

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