Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Can you apply?
This grant is for NIH-supported clinical research on ALS therapies for intermediate-stage patients. Eligible applicants include academic medical centers, research hospitals, and nonprofit research institutions with clinical trial capacity. Applicants must hold an IND (Investigational New Drug) authorization and IRB approval. Geographic scope is U.S.-based organizations only. Funding supports Phase I/II or Phase II clinical trial conduct, patient recruitment, and expanded access protocol operations.
This grant is for NIH-supported clinical research on ALS therapies for intermediate-stage patients. Eligible applicants include academic medical centers, research hospitals, and nonprofit research institutions with clinical trial capacity. Applicants must hold an IND (Investigational New Drug) authorization and IRB approval. Geographic scope is U.S.-based organizations only. Funding supports Phase I/II or Phase II clinical trial conduct, patient recruitment, and expanded access protocol operations.
Program description
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
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for NIH-supported clinical research on ALS therapies for intermediate-stage patients. Eligible applicants include academic medical centers, research hospitals, and nonprofit research institutions with clinical trial capacity. Applicants must hold an IND (Investigational New Drug) authorization and IRB approval. Geographic scope is U.S.-based organizations only. Funding supports Phase I/II or Phase II clinical trial conduct, patient recruitment, and expanded access protocol operations.
How to apply
Application links
Required documents
- SF-424 (R&R) application form
- Project Narrative (research plan)
- Biosketch of PI and key personnel
- Budget and budget justification
- IRB approval letter (or letter of intent if in progress)
- IND authorization documentation
- Preliminary data and safety reports
- Letters of support from clinical sites
- Human subjects protection plan
Program contact
- 👤 National Institutes of Health
- 📧 NINDSALSMailbox@mail.nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.853 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$82,511,281
-
$67,362,785
-
$62,646,087
-
$56,144,651
-
$45,268,737
-
$40,959,789
-
$35,655,349
-
$35,655,116
-
$35,335,145
-
$34,183,297
Top States by Funding
- MA 6 awards $186.5M
- CA 4 awards $129.9M
- OH 4 awards $112.5M
- FL 3 awards $100.3M
- MN 2 awards $99.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.853). How funding has trended year over year.
| 2024 | $2,362,835,459 | |
| 2025 | $2,345,500,401 |
FAQ
Who can apply for this grant?
Academic medical centers, teaching hospitals, research institutes, and nonprofit organizations with clinical trial infrastructure and regulatory approvals. Must have IND authorization and IRB approval in place.
What is the deadline and application window?
Applications open May 4, 2026 and close November 10, 2026. This is a fixed deadline with no rolling submissions.
What types of activities does this fund?
Clinical trial conduct, expanded access protocol operation, patient recruitment and enrollment, safety monitoring, and regulatory compliance. Does not fund basic laboratory research.
How competitive is this grant?
Very competitive. NIH clinical trial funding requires strong preliminary data, experienced research teams, and clear clinical significance for ALS patients.
What is the typical funding range?
U01 awards typically range from $500K–$2M annually depending on trial scope and patient population size. Multi-year funding is standard.
💡 Tips for applicants
- Establish IRB and IND approval before submitting. Reviewers will scrutinize regulatory readiness and timeline feasibility.
- Include detailed patient recruitment and retention plans. Show how you will reach intermediate-stage ALS patients efficiently.
- Demonstrate clinical team expertise in neurology and ALS care. Prior successful clinical trials strengthen your application.
- Present preliminary safety and efficacy data from prior phases or related studies. This is critical for expanded access justification.
- Address burden and diversity in enrollment. NIH strongly favors applications with plans to include underrepresented populations.
⚠️ Common mistakes
Weak recruitment and retention strategies; reviewers reject trials with unclear pathways to enrollment targets. Insufficient preliminary data or safety evidence; NIH requires solid Phase I/II results before expanded access approval. Underestimated regulatory burden; many applicants underestimate IND amendments and IRB modifications needed during trials.
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