Alzamend Neuro Reports Positive Topline Data from Phase II Clinical Trial of AL001 "Lithium in Brain" Study; AL001 Achieves Bioequivalence and Demonstrates Superior Brain Delivery Across All Measured Brain Regions

Alzamend Neuro (Nasdaq: ALZN) reported positive Phase II topline data for AL001 on March 26, 2026.

Rhea-AI Summary

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.

Positive

• Bioequivalence achieved: 101% total exposure and 97% peak versus lithium carbonate
• Whole-brain lithium exposure increased by ~7.8% for AL001
• Faster brain uptake: peak at 6.7 hours vs. 8.4 hours (≈1.7-hour advantage)
• 505(b)(2) pathway enabled potential due to demonstrated systemic bioequivalence

Negative

• Small sample size: 6 subjects per arm, results directional but not statistically definitive
• Next studies contingent on raising sufficient capital to start remaining Phase II trials
• Reported brain increases are numerical trends without reported statistical significance yet

Argus Mar 26 session

-22.28% close to close Open Argus

Details

News Market Reaction – ALZN

In the Mar 26 session, ALZN declined 22.28%, reflecting a significant negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock dropped -22.3% in the session following this news. A negative reaction despite positive to...

Analysis

The stock dropped -22.3% in the session following this news. A negative reaction despite positive topline findings would fit ALZN’s history of inconsistent responses to AL001 clinical updates, where several upbeat trial milestones still saw declines. Traders may focus on small sample size, preliminary nature of brain data, or broader financing and listing risks highlighted in recent filings. Given prior average clinical-trial moves of 8.92%, any outsized downside could reflect sentiment on balance-sheet and execution risk rather than this single dataset.

Key Figures

Total lithium exposure: 101% Peak lithium levels: 97% FDA bioequivalence range: 80%–125% +5 more

Total lithium exposure

101%

AL001 vs standard lithium carbonate blood exposure

Peak lithium levels

97%

AL001 vs standard lithium carbonate Cmax in blood

FDA bioequivalence range

80%–125%

Required systemic exposure range for new formulations

Brain exposure increase

~7.8%

Increase in maximum whole-brain lithium exposure vs lithium carbonate

Peak brain time AL001

6.7 hours

Time to peak brain lithium concentration

Peak brain time comparator

8.4 hours

Time to peak brain lithium for standard lithium carbonate

Sample size per arm

6 subjects

Healthy-subject brain tissue measurements in first Phase II trial

Planned Phase II patients

30 patients

Total across five planned Phase II "Lithium in Brain" trials

Previous Clinical trial Reports

5 past events · Latest: 2025-11-19

Same Type 5 events

1. 2025-11-19

   Phase II completion

   24h Move

   -5.3%

   Completion of clinical portion of Phase II AL001 brain/blood PK study at MGH.

2. 2025-05-29

   Phase II dosing

   24h Move

   +63.9%

   Dosing of first patient in Phase II AL001 trial with strong efficacy potential messaging.

3. 2025-05-19

   First patient enrolled

   24h Move

   +5.9%

   Enrollment of first patient in Phase II AL001 healthy-subject trial at MGH.

4. 2025-05-13

   Phase II initiation

   24h Move

   -18.8%

   Initiation of first Phase II AL001 trial comparing brain and blood PK to lithium carbonate.

5. 2025-03-25

   Alzheimer’s trial plan

   24h Move

   -1.0%

   Announcement of planned Phase II AL001 Alzheimer’s trial start at MGH in Q4 2025.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

bioequivalence, magnetic resonance imaging ("MRI"), magnetic resonance spectroscopy ("MRS"), section 505(b)2 new drug application, +1 more

5 terms

bioequivalence medical

"AL001 meets bioequivalence standards while also showing numerically superior lithium delivery"

When two medicines deliver the same amount of active ingredient into the bloodstream at about the same speed and level, they are considered bioequivalent. Investors care because bioequivalence is the regulatory test that allows generic or reformulated drugs to replace branded products without new safety trials, often opening large, lower‑cost market opportunities and changing a drug maker’s sales and competitive position—like two recipes that taste the same but sell at different prices.

magnetic resonance imaging ("MRI") medical

"Tesla head coil that provides advanced magnetic resonance imaging ("MRI") and magnetic resonance"

A magnetic resonance imaging (MRI) scan is a medical imaging technique that uses strong magnets and radio waves to create detailed pictures of the body's internal structures without surgery or X-rays. For investors, MRI matters because it underpins demand for expensive scanners, influences healthcare providers' capital spending, affects the adoption of new diagnostic technologies and treatment decisions, and is subject to regulatory approvals and reimbursement policies that can impact company revenue.

magnetic resonance spectroscopy ("MRS") medical

"magnetic resonance imaging ("MRI") and magnetic resonance spectroscopy ("MRS") neuroimaging, researchers"

A noninvasive imaging technique that uses the same principles as MRI to measure the chemical makeup of tissue, producing a molecular “fingerprint” rather than just a picture. Investors care because it can reveal disease markers and show whether a drug or therapy is changing the target tissue, which helps assess clinical trial progress, regulatory likelihood and the future commercial value of diagnostics and treatments.

section 505(b)2 new drug application regulatory

"Achieving bioequivalence supports a Section 505(b)2 new drug application submission for safety"

A section 505(b)(2) new drug application is an FDA approval pathway that lets a company rely partly on existing published studies or data from previously approved drugs instead of repeating all clinical tests. For investors, it can mean a faster, cheaper route to bring a modified drug to market—like renovating a house instead of building one from scratch—potentially reducing development risk and shortening the time to revenue while still offering prospects for market exclusivity or legal challenges.

therapeutic drug monitoring ("TDM") medical

"narrow therapeutic window and the need for regular therapeutic drug monitoring ("TDM") to manage"

Therapeutic drug monitoring is the practice of measuring the amount of a medicine in a patient’s blood and adjusting the dose so the drug works well without causing harm, like using a thermostat to keep a room at the right temperature. For investors, TDM matters because it can affect how a drug is labeled, how often patients need follow-up testing, the cost and complexity of treatment, and therefore the drug’s market acceptance, pricing power, and ongoing demand for related testing services.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• Bioequivalence Confirmed: AL001 delivered 101% of total lithium blood exposure and 97% of peak lithium levels vs. standard lithium carbonate
• Superior Brain Penetration: AL001 showed numerically higher lithium concentrations in all measured brain regions, including whole brain
• Faster Brain Uptake: AL001 reached peak brain concentration in 6.7 hours vs. 8.4 hours for standard lithium carbonate

ATLANTA, March 26, 2026 /PRNewswire/ -- Alzamend Neuro, Inc. (Nasdaq: ALZN) ("Alzamend"), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's disease ("Alzheimer's"), bipolar disorder type 1 ("BD"), major depressive disorder ("MDD") and post-traumatic stress disorder ("PTSD"), today announced positive topline data from its first Phase II "Lithium in Brain" clinical trial in healthy human subjects, demonstrating that AL001 meets bioequivalence standards while also showing numerically superior lithium delivery to the brain compared to standard lithium carbonate across all 26 measured brain regions including whole brain. These results suggest a promising differentiated pharmacological profile with significant implications for patients with Alzheimer's, BD, MDD and PTSD. The trial was conducted at Massachusetts General Hospital ("MGH") and represents a meaningful clinical and regulatory advance for AL001.

Phase II Topline Results

• AL001 Achieves Bioequivalence with Standard Lithium Carbonate:
  • The U.S. Food and Drug Administration (the "FDA") requires a new formulation to deliver between 80% to 125% of the reference drug to the bloodstream to support equivalent systemic safety. AL001 delivered 101% of total lithium exposure and 97% of peak lithium levels compared to standard lithium carbonate, which are both squarely within the required FDA range. Achieving bioequivalence supports a Section 505(b)2 new drug application submission for safety, potentially mitigating non-clinical requirements.
• Superior Brain Penetration Across all 26 Measured Regions, Including Whole Brain:
  • Using a one-of-a-kind Tesla head coil that provides advanced magnetic resonance imaging ("MRI") and magnetic resonance spectroscopy ("MRS") neuroimaging, researchers quantified lithium in 25 discrete brain regions as well as the whole brain. AL001 showed numerically higher lithium concentrations in every single region vs. standard lithium carbonate, including the hippocampus (memory), entorhinal cortex (early Alzheimer's target), cingulate gyrus (cognition), amygdala and accumbens regions. Maximum whole-brain lithium exposure increased ~7.8% for AL001 compared to lithium carbonate. A consistent directional increase across all measured brain regions is a compelling signal, and confirmation is already underway; the second of five planned Phase II trials, enrolling a total of 30 patients across the full program, is already underway at MGH.
• Faster Brain Uptake Results in Earlier Peak Concentration:
  • AL001 achieved peak brain lithium concentrations at 6.7 hours compared to 8.4 hours for standard lithium carbonate, resulting in a potential ~1.7-hour advantage. Faster brain uptake could have meaningful implications for therapeutic onset and dosing optimization, which will be evaluated in subsequent studies.
• Second Phase II Clinical Trial Already Underway at MGH:
  • In this first study, brain tissue measurements were conducted in six subjects per arm, which is a sample size that produces directionally meaningful, but not yet statistically definitive, results. The ~7.8% whole-brain lithium trend is worthy of further investigation. To that end, Alzamend has initiated its second Phase II "Lithium in Brain" clinical trial at MGH, this time in patients with BD, with topline data expected in the third quarter of 2026. The third, fourth, and fifth studies in the program enrolling patients with MDD, PTSD and Alzheimer's, respectively, are anticipated to begin in the latter half of 2026, subject to raising sufficient capital. Alzamend believes that results across all five studies, totaling 30 patients, will be adequate to establish statistical significance and advance AL001 toward further regulatory milestones.

"These data mark a pivotal advancement in the development of AL001," said Stephan Jackman, CEO of Alzamend. "We have clinical evidence that AL001 shows equivalent delivery of lithium in the bloodstream compared to standard lithium carbonate capsules, which is a key regulatory safety measure. And the brain data, while preliminary, show a consistent increase providing higher lithium in every brain region we measured. This can permit lower systemic doses to achieve efficacy thereby providing an enhanced safety profile. Combined with the faster brain uptake, we believe AL001 has a meaningfully differentiated profile compared to conventional lithium; one that could benefit the 43+ million Americans afflicted with Alzheimer's, BD, MDD and PTSD."

AL001: A Differentiated Lithium Therapy for a Large Unmet Need

Although lithium has remained the gold standard treatment for BD for more than 55 years, its clinical utility is constrained by a narrow therapeutic window and the need for regular therapeutic drug monitoring ("TDM") to manage renal, thyroid, and other systemic toxicity risks. AL001 is Alzamend's patented ionic cocrystal formulation of lithium combined for delivery with L-proline and salicylate, which is designed to deliver a full therapeutic amount of lithium to the brain with less systemic exposure than lithium carbonate, potentially enabling a safer, better-tolerated therapy across Alzheimer's, BD, MDD and PTSD.

About this Study

The study employed a randomized crossover design with multiple six-subject cohorts. Participants were assigned to one of two sequences: AB (AL001 then lithium carbonate) or BA (lithium carbonate then AL001). Each treatment period consisted of 14 days of three-times-daily ("TID") dosing, separated by a 14-day washout.

On Days 14–15, participants underwent 24-hour pharmacokinetic blood sampling alongside advanced MRI and MRS neuroimaging, a first-of-its-kind methodology. The MRI and MRS neuroimaging methods were developed by the lab of Dr. Ovidiu Andronesi, the study's principal investigator, Associate Professor of Radiology at Harvard University and the Director of Multinuclear Metabolic Imaging, Martinos Center for Biomedical Imaging, Department of Radiology, MGH, Harvard Medical School. The study also incorporated a specialized, engineered head coil developed by Tesla Dynamic Coils BV, designed to enable high-resolution, whole-brain lithium imaging. This approach enabled simultaneous quantification of lithium concentrations in blood and brain including individual structures, as well as assessment of brain and individual brain structure chemistry, metabolism, and biomarker effects.

The study specifically evaluated AL001's ability to enhance lithium delivery to targeted brain regions while reducing systemic exposure, an approach designed to address the long-standing safety and tolerability limitations associated with traditional lithium salts. The results from the study confirmed that AL001 matches blood levels of standard lithium carbonate, the reference drug, addressing FDA regulatory requirements for a new drug formulation, as well as providing a differentiated, potential dose-sparing benefit profile for patients.

About Alzamend Neuro

Alzamend is a clinical-stage biopharmaceutical company developing novel therapies for Alzheimer's, BD, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001, a patented ionic cocrystal delivering lithium with salicylate and L-proline designed to improve brain delivery and safety compared to conventional lithium, and ALZN002, a patented cell-based therapeutic vaccine designed to restore the immune system's ability to clear beta-amyloid. The latter is a next-generation active-immunity approach offering potential advantages in dosing frequency and cost compared to approved passive-immunity antibody therapies. Both candidates are exclusively licensed from the University of South Florida Research Foundation under royalty-bearing worldwide licenses.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "believes," "plans," "anticipates," "projects," "estimates," "expects," "intends," "strategy," "future," "opportunity," "may," "will," "should," "could," "potential," or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend's business and financial results are included in Alzamend's filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend's website at www.Alzamend.com.

 

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SOURCE Alzamend Neuro, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Alzamend (ALZN) announce on March 26, 2026 about AL001?

They announced Phase II topline results showing AL001 met bioequivalence and higher brain delivery. According to the company, AL001 delivered 101% systemic exposure, 97% peak, and showed numerically higher lithium across all 26 brain regions with ~7.8% higher whole-brain exposure.

Does AL001 meet FDA bioequivalence requirements for ALZN's regulatory path?

Yes, AL001 met FDA bioequivalence criteria for systemic exposure. According to the company, AL001 delivered 101% of total lithium exposure and 97% of peak levels versus lithium carbonate, supporting a potential Section 505(b)(2) submission for safety.

How much greater was brain lithium with AL001 compared to lithium carbonate in ALZN's study?

AL001 showed a numeric increase of about 7.8% in whole-brain lithium exposure. According to the company, every measured region trended higher versus lithium carbonate, though the small sample produced directional, not yet statistically definitive, results.

When will ALZN report additional Phase II results for AL001 and what trials are planned?

A second Phase II in bipolar disorder is already underway with topline data expected in Q3 2026. According to the company, three more Phase II studies for MDD, PTSD and Alzheimer's are planned later in 2026 pending capital.

What does the faster brain uptake of AL001 mean for patients and dosing?

Faster uptake may enable earlier therapeutic onset or dosing optimization. According to the company, AL001 reached peak brain concentration at 6.7 hours versus 8.4 hours for lithium carbonate, a potential ≈1.7-hour advantage to evaluate in future studies.