FDA Events for Alzamend Neuro (ALZN)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Alzamend Neuro (ALZN).
Over the past two years, Alzamend Neuro has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AL001. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AL001 - FDA Regulatory Timeline and Events
AL001 is a drug developed by Alzamend Neuro for the following indication: A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AL001
- Announced Date:
- May 29, 2025
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro, Inc. announced the dosing of the first patient of its first Phase II clinical study of AL001, in healthy human subjects. This study follows the successful development of a novel head coil by Tesla Dynamic Coils BV, a key component of the clinical trial.
AI Summary
Alzamend Neuro, Inc. has reached a significant milestone by dosing the first patient in its inaugural Phase II clinical trial of AL001, a novel lithium-delivery treatment being studied in healthy human subjects. This clinical trial marks a critical step in evaluating AL001’s potential to improve the delivery of lithium to the brain while reducing overall systemic exposure and side effects. A key element in executing the trial was the successful development of a novel head coil by Tesla Dynamic Coils BV, which is crucial for capturing detailed brain imaging data. This innovative approach, tested in partnership with Massachusetts General Hospital, aims to provide a safer, more efficient way to administer lithium compared to traditional formulations. The study will help determine the optimal path forward for treating conditions such as Alzheimer’s disease, bipolar disorder, major depressive disorder, and PTSD.
Read Announcement- Drug:
- AL001
- Announced Date:
- May 19, 2025
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro, Inc. announced the enrollment of the first patient of its first Phase II clinical study of AL001, in healthy human subjects. This study follows the successful development of a novel head coil by Tesla Dynamic Coils BV, a key component of the clinical trial.
AI Summary
Alzamend Neuro, Inc. has enrolled the first patient in its Phase II clinical study of AL001 in healthy human subjects. This important step comes after the successful development of a novel head coil by Tesla Dynamic Coils BV, a key tool used in the trial. The study is designed to test AL001’s ability to deliver lithium directly to the brain, potentially offering a more focused treatment with fewer side effects. Researchers hope that by improving how lithium is delivered, AL001 might eliminate the need for frequent blood level monitoring, which can be a significant challenge in current lithium therapies. This trial serves as a baseline to determine whether the new formulation could be effective for conditions such as Alzheimer’s disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder.
Read Announcement- Drug:
- AL001
- Announced Date:
- May 13, 2025
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro Tells Benzinga Co. Initiates First Phase II Clinical Trial Of AL001 Lithium Brain Study Taking Place At Massachusetts General Hospital
AI Summary
Alzamend Neuro announced the start of its first Phase II clinical study of AL001 at Massachusetts General Hospital. The trial will involve healthy human subjects to establish a baseline for AL001’s performance. The study is designed to evaluate how well AL001 can deliver lithium directly into the brain compared to existing lithium salts. Researchers hope that this targeted delivery will improve treatment outcomes for disorders such as Alzheimer’s, bipolar disorder, major depressive disorder, and post-traumatic stress disorder, while reducing systemic side effects that are common with traditional lithium therapies.
The study also incorporates advanced imaging technology using a novel head coil developed by Tesla Dynamic Coils BV. Topline data from the trial is expected by the end of 2025, which will help determine the next steps in exploring AL001’s potential for safer and more effective brain treatments.
Read Announcement- Drug:
- AL001
- Announced Date:
- May 7, 2025
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro Tells Benzinga Co. Partners With QMENTA To Advance AI-Powered Imaging For Its Phase II Clinical Trial Of AL001 Study
AI Summary
Alzamend Neuro recently announced its collaboration with QMENTA, a company specializing in artificial intelligence-powered medical imaging, to support its Phase II clinical trial of AL001. In this study, QMENTA’s cloud-based platform will manage and analyze imaging data gathered at Massachusetts General Hospital. This partnership is designed to ensure that all data meets regulatory compliance, enhances operational efficiency, and supports robust data management throughout the trial. The study aims to explore whether AL001 can deliver lithium more effectively to the brain, potentially reducing side effects compared to traditional lithium salts. Overall, the collaboration with QMENTA is expected to provide a valuable technological boost, helping researchers gain deeper insights into AL001’s performance and paving the way for more efficient treatments for conditions like Alzheimer’s, bipolar disorder, depression, and PTSD.
Read Announcement- Drug:
- AL001
- Announced Date:
- March 25, 2025
- Estimated Event Date Range:
- October 1, 2025 - December 31, 2025
- Target Action Date:
- Q4 2025
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro, Inc. announced its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment of patients with Alzheimer's in the fourth quarter of 2025.
AI Summary
Alzamend Neuro, Inc. has announced its plans to start a Phase II clinical study of its drug candidate AL001 for Alzheimer’s patients in the fourth quarter of 2025. This highly anticipated study will examine AL001’s potential to improve the delivery of lithium to the brain while reducing its presence in the bloodstream, a quality that may lessen side effects compared to current lithium salts. The trial, conducted in collaboration with Massachusetts General Hospital, aims to determine whether AL001 can offer targeted brain benefits without the need for frequent lithium monitoring typically required by traditional therapies. If successful, this research could lead to a new treatment option for Alzheimer’s that not only enhances patient safety but also simplifies the management of the disease, potentially improving the quality of life for millions of patients.
Read Announcement- Drug:
- AL001
- Announced Date:
- March 18, 2025
- Estimated Event Date Range:
- October 1, 2025 - December 31, 2025
- Target Action Date:
- Q4 2025
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro, Inc. announced its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment of patients with MDD in the fourth quarter of 2025.
AI Summary
Alzamend Neuro, Inc. has announced plans to begin a highly anticipated phase II clinical study of AL001 for major depressive disorder (MDD) in the fourth quarter of 2025. This study will explore AL001’s ability to deliver lithium directly to the brain in a more targeted way than current lithium carbonate products. The new approach aims to improve patient outcomes by reducing the need for constant monitoring of lithium levels. In collaboration with Massachusetts General Hospital as its research partner, the study will compare how AL001 affects both lithium blood levels and brain concentrations relative to traditional treatments. Preclinical studies in animals have suggested that AL001 may enhance brain absorption while maintaining lower blood lithium levels, potentially reducing side effects. If successful, this next-generation lithium treatment could provide a safer, more effective option for the millions of Americans suffering from MDD.
Read Announcement- Drug:
- AL001
- Announced Date:
- March 11, 2025
- Estimated Event Date Range:
- October 1, 2025 - December 31, 2025
- Target Action Date:
- Q4 2025
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro, Inc. announced its plans to initiate a phase 2 clinical study of AL001 for patients with post-traumatic stress disorder (PTSD) in the fourth quarter of 2025.
AI Summary
Alzamend Neuro, Inc. has announced plans to start a phase 2 clinical study of AL001 for patients with post-traumatic stress disorder (PTSD) in the fourth quarter of 2025. The study aims to explore how AL001 works on the brain and its ability to deliver lithium more effectively compared to standard lithium salts. In collaboration with Massachusetts General Hospital serving as its contract research organization, the research will focus on AL001’s targeted action and potential to reduce systemic side effects in PTSD patients. Prior animal studies have shown promising results, indicating that AL001 can improve brain absorption of lithium while keeping blood lithium levels lower, which may result in a safer and more efficient treatment. This upcoming trial could help show whether AL001 can become a practical treatment option for patients who suffer from PTSD.
Read Announcement- Drug:
- AL001
- Announced Date:
- March 4, 2025
- Estimated Event Date Range:
- July 1, 2025 - September 30, 2025
- Target Action Date:
- Q3 2025
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro, Inc. announced its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment of patients with BD, which is expected to commence in the third quarter of 2025.
AI Summary
Alzamend Neuro, Inc. announced plans to begin a phase II clinical study of its novel therapy, AL001, for treating patients with bipolar disorder. The study is expected to start in the third quarter of 2025. AL001 is designed to target the delivery of lithium directly to the brain, potentially offering better treatment outcomes with fewer side effects compared to conventional lithium salts. The trial will investigate whether AL001 can provide effective brain absorption while reducing the need for frequent therapeutic drug monitoring. In preclinical studies using mice, AL001 showed promising results with improved lithium distribution in the brain and lower levels in the blood. Alzamend will carry out this study in collaboration with Massachusetts General Hospital, hoping that this innovative approach will lead to a safer and simpler treatment option for the millions affected by bipolar disorder.
Read Announcement- Drug:
- AL001
- Announced Date:
- February 25, 2025
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 2025
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro, Inc announced its plans to initiate the first of five highly anticipated phase II clinical studies of AL001, with the first study, in healthy human subjects, expected to commence in the second quarter of 2025.
AI Summary
Alzamend Neuro, Inc. announced plans to launch the first of five phase II clinical studies for its innovative AL001 treatment. The initial study will involve healthy human subjects and is scheduled to begin in the second quarter of 2025. This trial aims to explore AL001’s unique ability to deliver lithium more efficiently to the brain compared to traditional lithium salts while reducing systemic side effects and the need for regular therapeutic drug monitoring. The research will serve as a baseline for future trials in patients suffering from Alzheimer’s disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. Alzamend hopes that the study will pave the way for a safer, more targeted lithium therapy that could significantly improve treatment outcomes.
Read Announcement- Drug:
- AL001
- Announced Date:
- February 19, 2025
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro, Inc. announced the completion of a groundbreaking head coil by Tesla Dynamic Coils BV ("Tesla").
AI Summary
Alzamend Neuro, Inc. announced a major breakthrough with the completion of a one-of-a-kind head coil developed by Tesla Dynamic Coils BV. This innovative head coil is set to play a critical role in their upcoming Phase II clinical trials. It will provide detailed whole-brain imaging to accurately measure how lithium is absorbed in different brain areas. By capturing precise images, researchers can compare lithium levels in the brain and blood, helping to identify the right doses for conditions like Alzheimer’s, bipolar disorder, major depressive disorder, and PTSD.
The advanced imaging tool is expected to give scientists better insights into how lithium works in the brain, which could lead to safer and more effective treatments. This development marks an important step forward in enhancing our understanding of lithium delivery and its potential benefits in treating various neurodegenerative and psychiatric disorders.
Read Announcement- Drug:
- AL001
- Announced Date:
- November 19, 2024
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro, Inc. announced that it has finished analyzing the final full data set from a nonclinical study comparing brain and plasma lithium exposures between AL001 and lithium carbonate in Alzheimer's transgenic mice.
AI Summary
Alzamend Neuro, Inc. has completed the final analysis of a nonclinical study comparing brain and plasma lithium exposures between its innovative product AL001 and lithium carbonate in Alzheimer’s transgenic mice. The study, carried out at the University of South Florida, involved giving mice scaled doses of AL001 and lithium carbonate over a 14-day period. On the 15th day, researchers measured lithium levels in various brain regions and plasma samples.
Results showed that at low doses, AL001 achieved higher lithium concentrations in key brain tissues compared to lithium carbonate. Additionally, AL001 resulted in lower plasma lithium levels, which could reduce the risk of side effects typically seen with current lithium therapies. These findings support the potential of AL001 to enhance brain-specific delivery of lithium and will help guide upcoming Phase II “Lithium in Brain” clinical trials in partnership with Massachusetts General Hospital.
Read Announcement- Drug:
- AL001
- Announced Date:
- August 26, 2024
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro, Inc. shared a letter from its Chief Executive Officer, Stephan Jackman.
AI Summary
Alzamend Neuro, Inc. shared a letter from its Chief Executive Officer, Stephan Jackman, detailing the company’s outlook and clinical program updates. In his letter, Jackman expressed optimism about Alzamend’s efforts to develop breakthrough treatments for conditions including Alzheimer’s, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. He highlighted their lead candidate, AL001, a novel lithium-delivery system engineered to provide the benefits of existing lithium treatments while reducing toxic side effects. Jackman also mentioned a forthcoming partnership with Massachusetts General Hospital, which will serve as the contract research organization for five Phase II clinical trials—one involving healthy subjects, and one each in patients with the specified conditions. The CEO emphasized that these trials are an important step toward achieving significant advancements in treatment options, thanking stockholders for their ongoing support and trust in the company’s direction.
Read Announcement- Drug:
- AL001
- Announced Date:
- August 19, 2024
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro, Inc announced that it is partnering with Massachusetts General Hospital as its contract research organization ("CRO") to conduct first of its kind Phase II clinical study of AL001 for treatment of patients with PTSD.
AI Summary
Alzamend Neuro, Inc. has partnered with Massachusetts General Hospital, a leading clinical research center affiliated with Harvard Medical School, to conduct a groundbreaking Phase II clinical study of its novel lithium-delivery system, AL001, for patients with post-traumatic stress disorder (PTSD). This study is the first of its kind and will compare AL001 head-to-head with a marketed lithium carbonate product to evaluate how well each treatment delivers lithium into the brain.
Harvard University Associate Professor Dr. Ovidiu Andronesi, who serves as the Director of Multinuclear Metabolic Imaging at Mass General, has been named the principal investigator. The research aims to identify the ideal, safe, and effective dose of AL001 that matches the benefits of current lithium treatments, but with improved safety and brain bioavailability for the 9+ million Americans suffering from PTSD.
Read Announcement- Drug:
- AL001
- Announced Date:
- August 12, 2024
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro, Inc. announced that it is partnering with Massachusetts General Hospital as its contract research organization ("CRO") to conduct first of its kind Phase II clinical study of AL001 for treatment of patients with MDD.
AI Summary
Alzamend Neuro, Inc. announced a first-of-its-kind Phase II clinical study for its novel lithium-delivery system, AL001, focused on treating Major Depressive Disorder (MDD). The company is partnering with Massachusetts General Hospital, which will serve as the contract research organization (CRO) for the trial. Harvard University Associate Professor Dr. Ovidiu Andronesi has been named the principal investigator for the study. In this head-to-head trial, AL001 will be compared to a marketed lithium carbonate product. The study will closely examine lithium levels and distribution within the brain, aiming to identify an optimal dose of AL001 that delivers comparable effectiveness and safety to existing lithium treatments while potentially reducing the need for regular therapeutic drug monitoring. This collaboration and study design mark a significant step forward in improving treatment options for MDD.
Read Announcement- Drug:
- AL001
- Announced Date:
- August 6, 2024
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro, Inc. announced that it is partnering with Massachusetts General Hospital as its contract research organization ("CRO") to conduct first of its kind Phase II clinical study of AL001 for treatment of patients with BD. Massachusetts General Hospital is the original and largest clinical education and research facility of Harvard Medical School/Harvard University and houses the world's largest hospital-based research program.
AI Summary
Alzamend Neuro, Inc. announced a major collaboration with Massachusetts General Hospital (MGH) to conduct a groundbreaking Phase II clinical study of its novel lithium-delivery system, AL001, for treating bipolar disorder (BD). The study will directly compare AL001 with a marketed lithium carbonate product by measuring lithium levels in the brain and its structures. This approach is intended to identify the minimum dose that is both safe and effective for patients with BD.
MGH, known as the original and largest clinical education and research facility of Harvard Medical School/Harvard University, houses the world’s largest hospital-based research program. Dr. Ovidiu Andronesi, an Associate Professor at Harvard University and Director at MGH’s Martinos Center for Biomedical Imaging, will serve as the study’s principal investigator. This collaboration is seen as a promising step toward delivering an improved therapy for millions affected by BD.
Read Announcement- Drug:
- AL001
- Announced Date:
- August 5, 2024
- Indication:
- A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Announcement
Alzamend Neuro Inc has partnered with Massachusetts General Hospital as its contract research organization to conduct a Phase 2 clinical trial of AL001 for Alzheimer’s.
Read Announcement
Alzamend Neuro FDA Events - Frequently Asked Questions
As of now, Alzamend Neuro (ALZN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Alzamend Neuro (ALZN) has reported FDA regulatory activity for AL001.
The most recent FDA-related event for Alzamend Neuro occurred on May 29, 2025, involving AL001. The update was categorized as "Dosing Update," with the company reporting: "Alzamend Neuro, Inc. announced the dosing of the first patient of its first Phase II clinical study of AL001, in healthy human subjects. This study follows the successful development of a novel head coil by Tesla Dynamic Coils BV, a key component of the clinical trial."
Currently, Alzamend Neuro has one therapy (AL001) targeting the following condition: A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ALZN) was last updated on 7/12/2025 by MarketBeat.com Staff
