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Research Report
TB-006: A Galectin-3-Targeting Monoclonal Antibody for Neurodegenerative and Neuroinflammatory Disorders
I. Executive Summary
TB-006 is an investigational humanized monoclonal antibody developed by TrueBinding, Inc., designed to target Galectin-3 (Gal3).[1] This protein is increasingly recognized for its role in the pathogenesis of various neurological disorders, primarily through its involvement in neuroinflammation and the aggregation of pathological proteins. The primary clinical focus for TB-006 has been Alzheimer's Disease (AD), where early-phase clinical trials have suggested potential for cognitive improvement and disease modification.[4] Beyond AD, TrueBinding is actively expanding the development of TB-006 into other neurological conditions, including Parkinson's Disease (PD), Autism Spectrum Disorder (ASD), and Acute Ischemic Stroke (AIS), with preclinical interest in Amyotrophic Lateral Sclerosis (ALS) and Glioblastoma.[2] Currently, TB-006 is in various stages of Phase 2 clinical development for these indications and is available for AD patients through an Expanded Access Program (EAP) in the U.S. and a Named Patient Program (NPP) in Hong Kong.[7] The therapeutic strategy of targeting Galectin-3 aims to address common underlying pathological mechanisms, particularly neuroinflammation and protein misfolding, which are implicated across this spectrum of diverse neurological diseases. This approach, if validated through ongoing and future clinical trials, could establish TB-006 as a significant and versatile therapeutic agent for conditions with high unmet medical needs.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/14 | Phase 2 | Recruiting | |||
2024/07/15 | Phase 2 | Recruiting | |||
2023/07/25 | N/A | AVAILABLE | |||
2022/07/27 | Phase 2 | Terminated | |||
2021/12/14 | Phase 2 | Withdrawn | |||
2021/10/12 | Phase 1 | Completed | |||
2021/06/10 | Phase 1 | Completed | |||
2021/03/16 | Phase 1 | Withdrawn |
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
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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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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