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Research Report
Dazukibart (PF-06823859): A Comprehensive Report on an Investigational Anti-Interferon-Beta Therapy
1. Introduction to Dazukibart (PF-06823859)
1.1. Overview and Therapeutic Class
Dazukibart is an investigational biologic therapeutic agent, distinguished as a mouse-derived, humanized IgG1κ monoclonal antibody.[1] Its primary therapeutic classification is an anti-interferon beta (IFNβ) therapy, indicating its mechanism is centered on neutralizing the activity of this specific cytokine.[2] The development of Dazukibart is principally focused on addressing idiopathic inflammatory myopathies (IIM), with particular emphasis on dermatomyositis (DM) and polymyositis (PM).[2] Furthermore, its therapeutic potential has been explored in the context of lupus, encompassing both systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE).[3]
The significance of Dazukibart in the landscape of emerging therapies stems from its targeted approach. It is designed to intervene in diseases where IFNβ is understood to be a key pathogenic driver, contributing to the underlying inflammation and immune dysregulation characteristic of these conditions.[5] This targeted strategy differentiates it from broader immunosuppressive agents and aligns with the contemporary paradigm of precision medicine in autoimmune disorders. The development program reflects a strategic focus on IFNβ-mediated diseases, suggesting an intent to leverage a well-defined mechanism of action across multiple autoimmune conditions where IFNβ is a common pathological denominator. This approach, if successful, could offer an efficient pathway to addressing unmet needs in several related disorders.
1.2. Key Identifiers
The precise identification of an investigational drug is paramount for accurate scientific communication and regulatory tracking. Dazukibart is known by several identifiers:
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/11/21 | Phase 3 | Recruiting | |||
2023/06/09 | Phase 3 | Recruiting | |||
2023/05/30 | Phase 2 | Recruiting | |||
2021/09/08 | Phase 1 | 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. |
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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