Overview
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Indication
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Associated Conditions
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Research Report
A Comprehensive Report on the Investigational Anti-TSLP Monoclonal Antibody: Bosakitug
Executive Summary
Bosakitug is an investigational, humanized monoclonal antibody representing a potentially significant advancement in the treatment of a broad spectrum of immuno-inflammatory diseases. As a high-affinity inhibitor of thymic stromal lymphopoietin (TSLP), Bosakitug targets a master regulator cytokine positioned at the apex of the Type 2 inflammatory cascade. This upstream mechanism of action provides a strong biological rationale for its development across multiple atopic, respiratory, and immunologic disorders. The compound is being co-developed under a geographically segmented global strategy by Aclaris Therapeutics (worldwide, excluding Greater China) and Chia Tai Tianqing Pharmaceutical Group (Greater China), having been originated by Biosion, Inc.
The most compelling evidence for Bosakitug's therapeutic potential comes from the Phase 2a ADAMANT proof-of-concept study in patients with moderate-to-severe atopic dermatitis. In this trial, Bosakitug demonstrated an exceptionally high degree of efficacy, with the vast majority of patients achieving clear or almost clear skin and profound improvements in eczema severity. These results, combined with a highly favorable safety and tolerability profile characterized by the absence of serious adverse events or anti-drug antibody formation, position Bosakitug as a formidable competitor to existing biologics, including the market leader dupilumab.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/10 | Phase 2 | Recruiting | |||
2023/07/06 | Phase 2 | Completed | |||
2021/11/10 | Phase 1 | Completed | |||
2021/06/11 | Phase 1 | UNKNOWN |
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. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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