Overview
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Indication
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Research Report
Latozinemab (AL001): A Comprehensive Clinical and Scientific Review of a Progranulin-Elevating Monoclonal Antibody for the Treatment of Frontotemporal Dementia
I. Executive Summary
Latozinemab, also known by its development codes AL001 and GSK4527223, is an investigational, first-in-class humanized monoclonal antibody representing a novel immuno-neurology approach to treating neurodegenerative disease. Developed by Alector, Inc. in a major global collaboration with GSK, Latozinemab is designed to address the underlying genetic cause of a specific, devastating form of early-onset dementia: Frontotemporal Dementia with a progranulin gene (GRN) mutation (FTD-GRN). This condition is characterized by a haploinsufficiency of the progranulin (PGRN) protein, a critical regulator of lysosomal health and immune activity in the brain. Instead of attempting direct protein replacement, Latozinemab employs a sophisticated mechanism, targeting and inhibiting the sortilin (SORT1) receptor. SORT1 is the primary receptor responsible for the endocytosis and subsequent lysosomal degradation of PGRN. By blocking this pathway, Latozinemab effectively increases the half-life and circulating levels of endogenous PGRN.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/10 | Phase 1 | Active, not recruiting | |||
2025/02/21 | Phase 2 | Not yet recruiting | Beijing Anlong Biopharmaceutical Co., Ltd. | ||
2024/11/27 | Phase 1 | Active, not recruiting | Beijing Anlong Biopharmaceutical Co., Ltd. | ||
2023/11/01 | Phase 3 | ENROLLING_BY_INVITATION | |||
2022/05/05 | Phase 1 | Completed | |||
2021/09/22 | Phase 2 | Terminated | |||
2020/05/05 | Phase 3 | Active, not recruiting | |||
2019/06/17 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
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