Drugs / Latozinemab
Latozinemab
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06921590 | May → Dec 2025 overdue | — | Alzamend Neuro, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03636204 | Sep 2018 → Dec 2019 | frontotemporal dementia | Alector Inc. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07540338 | Apr → Dec 2026 expected | bipolar I disorder | Alzamend Neuro, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06707753 | Sep 2023 → Aug 2025 overdue | wet macular degeneration | Beijing Anlong Biopharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05363293 | May 2022 → Apr 2023 | Alzheimer disease | Alzamend Neuro, Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06839339 | Feb 2025 → Sep 2026 overdue | wet macular degeneration | Beijing Anlong Biopharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05053035 | Sep 2021 → Oct 2022 | amyotrophic lateral sclerosis | Alector Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03987295 | Sep 2019 → Jun 2024 | frontotemporal dementia | Alector Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06111014 | Dec 2023 → Sep 2025 | neurodegenerative disease | Alector Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT04374136 | Jul 2020 → Sep 2025 | frontotemporal dementia | Alector Inc. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2026-04-07 | Alzamend Neuro, Inc. | Results Alzamend Neuro Reports Encouraging Pharmacodynamic Data from Phase II Clinical Trial of AL001 "Lithium in Brain" Study in a Trial Conducted at Massachusetts General Hospital alzamend.com ↗
Early data suggest AL001 may work like lithium carbonate by selectively impacting brain chemicals where needed, however, AL001 appears to be leaving other, healthy brain chemicals more undisturbed than lithium carbonate, a potentially meaningful tolerability advantage. |
| 2026-03-26 | Alzamend Neuro, Inc. | Results 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.com ↗
AL001 reached peak brain concentration in 6.7 hours vs. 8.4 hours for standard lithium carbonate |
| 2024-12-18 | Alzamend Neuro, Inc. | Results Alzamend Neuro to Present Non-Clinical Data Update at the Society of Toxicology 2025 Annual Meeting and ToxExpo alzamend.com ↗ |
| 2024-11-19 | Alzamend Neuro, Inc. | Results Alzamend Neuro Announces Full Data Set from its Nonclinical Study: Comparing Brain and Plasma Lithium Exposures between AL001 and Lithium Carbonate in Alzheimer’s Transgenic Mice alzamend.com ↗
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 (“ BD ”), major depressive disorder (“ MDD ”) and post-traumatic stress disorder (“ PTSD ”), today 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. |
| 2024-10-16 | Alzamend Neuro, Inc. | Results Alzamend Neuro Announces Full Data Set from Phase IIA Multiple Ascending Dose Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s alzamend.com ↗
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 (“ BD ”), major depressive disorder (“ MDD ”) and post-traumatic stress disorder (“ PTSD ”), today announced that it has received the final full data set from its multiple ascending dose clinical trial for AL001 treatment of dementia related to Alzheimer’s. |
| 2023-12-11 | Alzamend Neuro, Inc. | Regulatory Alzamend Neuro Receives FDA “Study May Proceed” Notification for a Phase IIA Clinical Trial of AL001, a Next‑Generation Lithium Therapeutic Drug Candidate, in Post-Traumatic Stress Disorder Patients alzamend.com ↗ |
| 2023-11-20 | Alzamend Neuro, Inc. | Regulatory Alzamend Neuro Receives FDA “Study May Proceed” Notification for a Phase IIA Clinical Trial of AL001, a Next‑Generation Lithium Therapeutic Drug Candidate, in Major Depressive Disorder Patients alzamend.com ↗ |
| 2023-11-13 | Alzamend Neuro, Inc. | Regulatory Alzamend Neuro Submits IND Application for a Phase IIA Clinical Trial in Post-Traumatic Stress Disorder Patients of Next‑Generation Lithium Therapeutic Drug Candidate AL001 alzamend.com ↗ |
| 2023-10-23 | Alzamend Neuro, Inc. | Regulatory Alzamend Neuro Submits IND Application for a Phase IIA Clinical Trial in Major Depressive Disorder Patients of its Next‑Generation Lithium Therapeutic Drug Candidate AL001 alzamend.com ↗ |
| 2023-10-02 | Alzamend Neuro, Inc. | Regulatory Alzamend Neuro Receives FDA “Study May Proceed” Notification for a Phase IIA Clinical Trial of AL001, a Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients alzamend.com ↗
We are grateful to receive this timely, favorable response from the FDA to initiate our first Phase IIA clinical study of AL001 for BD. |
| 2023-08-30 | Alzamend Neuro, Inc. | Regulatory Alzamend Neuro Submits IND Application for Phase IIA Clinical Trial of AL001, a Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients alzamend.com ↗
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 (“ BD ”), major depressive disorder (“ MDD ”) and post-traumatic stress disorder (“ PTSD ”), today announced that it has submitted an investigational new drug (“ IND ”) application to the U.S. Food and Drug Administration (“ FDA ”) for the initiation of study AL001-BD01, a Phase IIA clinical study of AL001 for BD. |
| 2023-06-22 | Alzamend Neuro, Inc. | Results Alzamend Neuro Announces Positive Phase IIA Clinical Trial Results for AL001 alzamend.com ↗ |
| 2022-07-18 | Alzamend Neuro, Inc. | Regulatory Alzamend Neuro Receives Positive Pre-IND Response from FDA for AL001 Treatment of Bipolar Disorder, Major Depressive Disorder and Post-Traumatic Stress Disorder alzamend.com ↗
The FDA’s response provides a path for Alzamend’s planned clinical development of AL001 for the treatment of bipolar disorder, MDD and PTSD. |
| 2022-05-17 | Alzamend Neuro, Inc. | Regulatory Alzamend Neuro Announces Pre-IND Submission for AL001 as a Treatment of Bipolar Disorder, Major Depressive Disorder and Post-Traumatic Stress Disorder alzamend.com ↗ |
| 2022-03-28 | Alzamend Neuro, Inc. | Results Alzamend Neuro Announces Full Data Set From Phase 1 First-in-Human Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s alzamend.com ↗
Data confirm the positive topline results announced in December 2021 demonstrating AL001 in plasma is bioequivalent to the marketed lithium carbonate product |
| 2021-12-17 | Alzamend Neuro, Inc. | Results Alzamend Neuro Announces Positive Topline Data from Phase 1 First-in-Human Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s alzamend.com ↗
Data shows that AL001 is bioequivalent to the marketed lithium carbonate product and the shapes of the lithium plasma concentration versus time curves are similar |
| 2021-07-28 | Alzamend Neuro, Inc. | Regulatory Alzamend Neuro Receives FDA “Study May Proceed” Letter for Phase 1 Clinical Study Under Its Investigational New Drug Application for AL001 for Dementia Related to Alzheimer’s Disease alzamend.com ↗
“We are grateful to receive this timely, favorable response from the FDA to initiate a Phase 1 trial with AL001,” said Stephan Jackman , the Chief Executive Officer of Alzamend. |
| 2021-07-12 | Alzamend Neuro, Inc. | Regulatory Alzamend Neuro, Inc. to Ring Nasdaq Opening Bell Today alzamend.com ↗
We have recently submitted our IND application for our therapeutic, AL001, utilizing funding from our initial public offering, and look forward to continuing to advance our proprietary pipeline. |
| 2021-07-01 | Alzamend Neuro, Inc. | Regulatory Alzamend Neuro Submits IND Application for AL001 for Dementia Related to Alzheimer’s Disease alzamend.com ↗
Alzamend Neuro ®, Inc. (Nasdaq: ALZN) (“ Alzamend ”), a preclinical stage biopharmaceutical company, today announced that it submitted an investigational new drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for the initiation of a Phase 1 clinical study of AL001 on June 30, 2021. |
All press releases naming this drug 42 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Latozinemab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06111014 ↗ |
| Known as | AL001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05363293 ↗ |
| Known as | Alzamend AL001 | “Alzamend AL001” NCT05363293 ↗ |
| Modality | Monoclonal antibody | — CHEMBL4650439 ↗ |
| Route | Intravenous | “intravenously administered AL001” NCT03636204 ↗ |