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Alzamend Neuro, Inc. reports clinical-stage biopharmaceutical developments for therapies aimed at Alzheimer's disease, bipolar disorder, major depressive disorder and post-traumatic stress disorder. Its pipeline centers on AL001, a patented ionic cocrystal formulation that delivers lithium with salicylate and L-proline, and ALZN002, a cell-based therapeutic vaccine approach designed to target Alzheimer's beta-amyloid.
Recurring news includes Phase II “Lithium in Brain” clinical study updates, brain and blood lithium pharmacokinetic and pharmacodynamic data, research activity with Massachusetts General Hospital, scientific presentations, annual financial results and financing actions supporting the company's clinical programs.
Alzamend Neuro (NASDAQ: ALZN) reported preliminary pharmacodynamic MRS data from a healthy-subject study (N=6) at Massachusetts General Hospital on April 7, 2026. After two weeks of blood-bioequivalent AL001 versus lithium carbonate, AL001 trended toward myo-inositol reduction in 17 of 18 brain regions and showed minimal glutamate effects in 10 of 18 regions. Results are qualitative and require statistical confirmation in larger, adequately powered patient studies now underway.
Alzamend Neuro (Nasdaq: ALZN) reported positive Phase II topline data for AL001 on March 26, 2026. AL001 achieved bioequivalence to lithium carbonate (101% total exposure; 97% peak) and showed ~7.8% higher whole-brain lithium with faster peak brain uptake (6.7h vs. 8.4h).
Six subjects per arm produced directional, non‑definitive results; a second Phase II in bipolar disorder is underway with topline data expected Q3 2026. Further trials depend on capital raising.
Alzamend Neuro (Nasdaq: ALZN) initiated a Phase II crossover trial of AL001 in bipolar disorder type 1 at Massachusetts General Hospital to compare brain and blood lithium pharmacokinetics versus lithium carbonate. Topline BD data are expected in Q3 2026; healthy-subject imaging topline data expected end-March 2026.
The study uses 14-day TID dosing periods, a 14-day washout, intensive 24-hour PK sampling with MRI/MRS lithium imaging, and an engineered head coil; the selected MTD equals a lithium carbonate equivalent of 240 mg TID.
Alzamend Neuro (Nasdaq: ALZN) announced completion of the clinical portion of its Phase II study of AL001 in healthy subjects on Nov 19, 2025. The study compared lithium blood and brain pharmacokinetics of AL001 versus a marketed lithium carbonate product using a proprietary high-resolution whole-brain lithium imaging head coil from Tesla Dynamic Coils BV.
Topline data are expected in Q1 2026. Company says results will inform planned Phase II trials in Alzheimer's, bipolar disorder, major depressive disorder, and PTSD next year; prior mouse studies reportedly showed higher brain uptake with lower blood lithium levels.
Alzamend Neuro (Nasdaq: ALZN), a clinical-stage biopharmaceutical company, will present a poster at the 2025 Military Health System Research Symposium (MHSRS) from August 4-7 in Orlando, Florida.
The presentation, scheduled for August 6, 2025, will focus on quantitative differences in lithium brain-to-plasma exposure between AL001 and lithium carbonate in PTSD subjects. The study aims to contribute to a database comparing brain-plasma assessments across various neurological disorders.
CEO Stephan Jackman will present findings related to AL001, which is being developed for Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD. The company plans to engage with DoD funding directors to pursue non-dilutive funding opportunities through grants.
Alzamend Neuro (Nasdaq: ALZN) reported its annual financial results for FY2025 and provided updates on its clinical programs. The company significantly improved its financial position with stockholder equity reaching $4.0 million and cash holdings of $3.9 million as of April 30, 2025. In June 2025, Alzamend completed a $5 million private placement ahead of schedule.
The company's lead candidate AL001, a lithium-based treatment for Alzheimer's, bipolar disorder, major depressive disorder, and PTSD, began the first of five Phase II trials at Massachusetts General Hospital in May 2025. Their second candidate, ALZN002, an immunotherapy treatment for Alzheimer's, faced delays after their CRO terminated the agreement in February 2024, and the company is seeking a new partner to continue the Phase I/IIA trial.
Alzamend Neuro (NASDAQ: ALZN) has initiated dosing in its Phase II clinical trial of AL001, a novel lithium formulation, at Massachusetts General Hospital. The study aims to compare AL001's brain absorption and blood levels against existing lithium carbonate products in healthy subjects. Topline data is expected by the end of 2025.
AL001 represents a potential breakthrough in lithium-based treatments, as previous mouse studies demonstrated improved brain absorption with lower blood levels, potentially eliminating the need for therapeutic drug monitoring (TDM). This advancement could benefit over 43 million Americans affected by Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD.
The trial follows the successful development of a novel head coil by Tesla Dynamic Coils BV, which is crucial for the study's execution.Alzamend Neuro (NASDAQ: ALZN) has enrolled its first patient in a Phase II clinical trial for AL001, a novel lithium formulation, at Massachusetts General Hospital. The study aims to compare AL001's brain absorption and blood levels against marketed lithium carbonate in healthy subjects, with topline data expected by year-end 2025.
AL001 shows promise in delivering lithium more effectively to the brain while maintaining lower blood levels, potentially eliminating the need for therapeutic drug monitoring (TDM). Previous mouse studies demonstrated better brain absorption with reduced systemic exposure. The treatment targets multiple conditions, including Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD, potentially benefiting over 43 million Americans.
Alzamend Neuro (NASDAQ: ALZN) has initiated its first of five Phase II clinical trials for AL001, a novel lithium-based treatment, at Massachusetts General Hospital. The study will compare AL001 with marketed lithium carbonate to evaluate brain and blood pharmacokinetics in healthy subjects, with topline data expected by year-end.
AL001 represents a potential breakthrough in lithium treatment, showing better brain absorption while maintaining lower blood levels in previous mouse studies. The drug aims to eliminate the need for therapeutic drug monitoring (TDM), addressing a major limitation of current lithium treatments. This advancement could benefit over 43 million Americans affected by Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD.