A new nasal medicine to help thinking and behavior in people with FASD
Title: Developing a novel drug for neurobehavioral deficits in FASD
This project is developing a nasal peptide called FA-1 aimed at improving learning, memory, and behavior in people with Fetal Alcohol Spectrum Disorders.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Cogthera, LLC NIH-funded |
| Lab location | 1 site (Brookeville, United States) |
| Project ID | NIH-11255364 on NIH RePORTER |
What this research studies
Researchers plan to make clinical-grade FA-1 and test how the drug behaves in the body, how it affects brain targets, and whether it is safe in laboratory studies. They will optimize a nasal spray formulation and gather data on pharmacokinetics and pharmacodynamics. The team will also test FA-1 in animal models of prenatal alcohol exposure to see if it improves cognitive and behavioral problems. Finally, they will seek early regulatory feedback from the FDA to help prepare for future human trials.
Who could benefit from this research
Good fit: People diagnosed with Fetal Alcohol Spectrum Disorders who have persistent learning, memory, or behavioral difficulties would be the likely candidates for future human trials.
Not a fit: People whose symptoms are not related to prenatal alcohol exposure or whose problems are mainly physical rather than cognitive or behavioral are unlikely to benefit from this drug.
Why it matters
Potential benefit: If successful, FA-1 could offer a new treatment to reduce learning and behavior problems caused by prenatal alcohol exposure.
How similar studies have performed: Early lab and mouse studies showed behavioral improvements with intranasal peptide compounds, and FA-1 passed initial Phase I safety and efficacy testing, but benefit in people has not yet been demonstrated.
Where this research is happening
Brookeville, United States
- Cogthera, LLC — Brookeville, United States (Active)
Researchers
- Principal investigator: Torii, Masaaki — Cogthera, LLC
- Study coordinator: Torii, Masaaki
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 below.