CNM-Au8 Expanded Access for ALS patients across the U.S.
Official title: Intermediate-sized Expanded Access Protocol for CNM-Au8 in Amyotrophic Lateral Sclerosis (ALS).
Funded at New York University School of Medicine · NIH-11415221 · Data updated 2026-11-12
A wide-access program is testing CNM-Au8, a neuroprotective medicine, for people with ALS across all 50 states.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | New York University School of Medicine NIH-funded |
| Lab location | 1 site (New York, United States) |
| Project start | September 25, 2023 |
| Project end | August 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $10,658,357 |
| NIH project number | 5U01NS136023-04 |
| Project ID | NIH-11415221 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with ALS who can access treatment across the U.S., including those in rural or remote regions, may qualify.
✕Less likely to help
Patients who cannot tolerate the drug or who do not respond to treatment may not experience benefits.
What this research studies
This program aims to provide CNM-Au8 to people living with ALS, including those in remote areas, to see if the treatment can help protect nerve cells and support energy production in neurons. It builds on prior ALS research showing energetic and mitochondrial issues in motor neurons and how CNM-Au8 might raise energy metabolites like NAD+ and ATP. Participants would receive CNM-Au8 and be monitored for safety and potential benefits as part of a national expanded-access protocol. The study leverages collaboration between Columbia University, Clene, Synapticure, and NYU School of Medicine to reach a broad ALS population. Data collected may inform future clinical development and patient care approaches for ALS.
Why it matters
Potential benefit: If successful, CNM-Au8 could become an accessible option to help protect neurons and slow disease progression in ALS.
How similar studies have gone: Previous Phase 2 ALS trials suggest potential neuroprotective effects of CNM-Au8, supporting further exploration.
Where this research is happening
-
New York University School of Medicine
New York, United States Active
Researchers
- Principal investigator: Andrews, Jinsy — New York University School of Medicine
- Study coordinator: Andrews, Jinsy
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.