Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Oct 19, 2026
Can you apply?
This grant is for research organizations that can conduct clinical trials using data from expanded access protocols for ALS drugs. Applicants must partner with or have access to intermediate-size patient populations receiving investigational ALS treatments. The research must generate data on drug efficacy, biomarkers, safety outcomes, or patient experience. NIH-eligible institutions and principal investigators can apply. This is a cooperative agreement supporting scientific research rather than drug development itself.
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Key dates
- Sep 23, 2026 Applications open
- May 25, 2027 Application deadline in 217 days
- Apr 1, 2028 Award announced
- Apr 1, 2028 Project start
Program description
The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting the conduct of scientific research utilizing data from intermediate-size patient population expanded access protocols for ALS (“intermediate expanded access protocol for ALS”, see Expanded Access Categories for Drugs (Including Biologics)). Eligible intermediate expanded access protocols for ALS should: 1) provide access to an investigational drug or biological product for people with ALS, and 2) generate data to support research on the prevention, diagnosis, mitigation, treatment, or cure of ALS. The scientific research goal(s) informed by these data could include the investigational drug’s or biological product’s effect on biomarkers related to the pathophysiology of ALS or target engagement, the collection of safety or outcome information, such as survival or other significant medical events (e.g., hospitalization or need for ventilatory support), or patient experience data that are not specifically tied to assessing efficacy.
Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop responsive projects.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) Application Form
- Project Narrative (Research Plan)
- Budget and Budget Justification
- Biographical Sketches (Key Personnel)
- Data Access/Sharing Agreements
- Letters of Support from Expanded Access Protocol Sites
- IRB Approval or Plan for Approval
Program contact
- 👤 ALS Program
- 📧 NINDSALSMailbox@mail.nih.gov
- 📞 Please contact via email.
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
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$56,262,774
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$45,083,283
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$43,730,658
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$38,186,781
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$37,769,493
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$35,655,349
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$35,655,116
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$34,183,297
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$32,294,153
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$32,164,022
Top States by Funding
- MA 7 awards $186.3M
- CA 6 awards $163.5M
- FL 4 awards $121.0M
- OH 4 awards $112.5M
- NY 3 awards $91.7M
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?
Research institutions, universities, and organizations with IRB approval and access to expanded access protocol data. You need partnership or access to patient populations receiving investigational ALS treatments.
When is the deadline?
The fixed deadline is May 25, 2027. Applications are not currently being solicited; this notice allows time to develop projects.
What research activities are supported?
Studies analyzing expanded access protocol data on drug safety, biomarkers, patient outcomes (survival, hospitalization, ventilatory support), and patient experience. Not direct drug development.
What makes applications competitive?
Clear scientific questions, robust data access agreements, strong safety/outcome data collection, and relevance to ALS pathophysiology or treatment optimization.
What is the funding range?
Award amounts are not specified in this notice. Contact NINDS for estimated budgets.
💡 Tips for applicants
- Partner early with expanded access protocol sites to secure data access agreements and patient population commitments before application.
- Focus on research questions that leverage your protocol's unique patient data rather than replicating standard clinical trials.
- Clearly describe data collection protocols, sample sizes, and data quality assurance measures.
- Include letters of support from the drug manufacturer or expanded access protocol sponsors demonstrating data sharing capacity.
- Emphasize how your research will advance ALS understanding beyond the original protocol's safety monitoring.
⚠️ Common mistakes
Applications lack clear data access agreements or fail to demonstrate sufficient partnership with the expanded access protocol. Proposals treat this as direct drug development funding instead of focusing on research using existing protocol data. Weak or missing plans for patient safety oversight and regulatory compliance with FDA expanded access requirements.
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