Alzamend Neuro Inc. (NASDAQ: ALZN) announced results from its phase II clinical trial showing that AL001, its lithium formulation, achieved bioequivalence with standard lithium carbonate while demonstrating higher lithium concentrations across all 26 measured brain regions.

The trial, conducted at Massachusetts General Hospital, found that AL001 delivered 101% of total lithium blood exposure and 97% of peak lithium levels compared to standard lithium carbonate, meeting FDA bioequivalence requirements of 80% to 125%. The drug showed numerically higher lithium concentrations in every brain region measured, including a 7.8% increase in maximum whole-brain lithium exposure.

AL001 reached peak brain concentration in 6.7 hours versus 8.4 hours for standard lithium carbonate. The study used a randomized crossover design with six subjects per treatment arm, employing advanced MRI and magnetic resonance spectroscopy neuroimaging to quantify lithium concentrations.

The company has initiated a second phase II trial in patients with bipolar disorder, with results expected in the third quarter of 2026. Additional studies in patients with major depressive disorder, PTSD and Alzheimer's disease are planned for the latter half of 2026, subject to raising sufficient capital.

AL001 is a patented ionic cocrystal formulation combining lithium with L-proline and salicylate, designed to deliver therapeutic amounts of lithium to the brain with reduced systemic exposure compared to lithium carbonate. The company is developing treatments for Alzheimer's disease, bipolar disorder, major depressive disorder and PTSD.

The trial results are based on a press release statement from Alzamend Neuro.