Alzamend Neuro's AL001 Shows 7.8% Higher Brain Lithium Delivery, Faster 6.7h Uptake
AL001 achieved 101% total lithium blood exposure and 97% peak levels versus standard lithium carbonate, meeting FDA bioequivalence standards, while delivering ~7.8% higher lithium concentrations across all 26 measured brain regions. It reached peak brain levels in 6.7 hours—1.7 hours faster than standard lithium carbonate.
1. Bioequivalence Achievement
AL001 delivered 101% total lithium exposure and 97% peak levels compared to lithium carbonate, meeting FDA’s 80–125% requirement for systemic safety. This supports a Section 505(b)(2) application pathway and may reduce nonclinical testing demands.
2. Superior Brain Penetration
Using advanced MRI/MRS imaging, AL001 showed a ~7.8% increase in maximum whole-brain lithium exposure and numerically higher concentrations in all 26 measured regions, including the hippocampus and entorhinal cortex. Consistent directional gains suggest a differentiated pharmacological profile.
3. Faster Brain Uptake
AL001 reached peak brain concentrations in 6.7 hours versus 8.4 hours for standard lithium carbonate, offering a potential 1.7-hour advantage for therapeutic onset. The crossover study enrolled six healthy subjects per arm with 14-day dosing and a 14-day washout.
4. Upcoming Phase II Trials and Outlook
A second Phase II trial in bipolar disorder patients is already underway at Massachusetts General Hospital with topline data expected in Q3 2026. Three additional studies in major depressive disorder, PTSD and Alzheimer’s are slated for late 2026, contingent on funding.