CMS121 long-term safety testing to support Alzheimer’s drug development
Official title: Long-term, non-clinical toxicology for advancing CMS121 to Phase 2 trials for AD
Funded at Virogenics, INC. · NIH-11550675 · Data updated 2026-11-12
A non-clinical safety study in animals is planned to support advancing CMS121 for Alzheimer’s disease into a Phase 2 trial.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Virogenics, INC. NIH-funded |
| Lab location | 1 site (Del Mar, United States) |
| Project start | September 24, 2024 |
| Project end | August 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $193,672 |
| NIH project number | 3U01AG084549-03S1 |
| Project ID | NIH-11550675 on NIH RePORTER |
Who could benefit from this research
✓Could help
Not applicable to patient enrollment; guards for future trial participants will rely on later human studies.
✕Less likely to help
This non-clinical work does not involve patients or provide direct benefits to individuals now.
What this research studies
This project will produce large quantities of CMS121-M and conduct 6-month rat and 9-month dog toxicology studies to assess safety with daily dosing. The results will inform dosing strategies and study designs for future human trials. The work includes manufacturing scale-up and executing long-term safety tests under FDA guidance at Virogenics, Inc. in Del Mar. Overall, it aims to ensure that CMS121 can be safely tested in people with Alzheimer’s disease.
Why it matters
Potential benefit: If successful, the toxicology data could support a safer, more informed move into Phase 2 trials for CMS121 in Alzheimer’s patients.
How similar studies have gone: Long-term animal toxicology is a standard step and has precedents guiding human trial design for AD drugs.
Where this research is happening
-
Virogenics, INC.
Del Mar, United States Active
Researchers
- Principal investigator: Raschke, William C — Virogenics, INC.
- Study coordinator: Raschke, William C
Related research
Other NIH-funded projects on the same topics.
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New drug CMS121 to help people with Alzheimer’s disease
A promising new drug candidate called CMS121 is being studied to support a long-term treatment plan for adults with mild to moderate Alzheimer’s disease.
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Long-term safety testing of CMS121 for people with mild to moderate Alzheimer's disease
This project is testing whether the new pill CMS121 can be safely given every day for a long time to adults with mild to moderate Alzheimer's disease.
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Developing a new treatment for Alzheimer's Disease
This study is testing a new drug called CMS121 that could help improve memory and thinking skills in people with Alzheimer's Disease, offering a different approach than current treatments, and it might make a real difference if it works well in trials.
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Investigating a new treatment for Alzheimer's Disease
This study is testing a new drug called CMS121 to see if it can help people with mild to moderate Alzheimer's Disease by improving memory and thinking skills, while also making sure it's safe to take every day.
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.