Overview
Lebrikizumab has been used in trials studying the treatment of Asthma, Allergic Asthma, Atopic Dermatitis, Idiopathic Pulmonary Fibrosis, and COPD, Chronic Obstructive Pulmonary Disease.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Lebrikizumab (Ebglyss): A Comprehensive Clinical and Pharmacological Monograph for the Treatment of Atopic Dermatitis
Molecular Profile and Pharmacological Basis
Lebrikizumab represents a significant advancement in the targeted biological therapy of atopic dermatitis (AD), a chronic inflammatory skin disease driven by Type 2 immune responses. Its development and clinical profile are rooted in a precise molecular design engineered to potently and selectively neutralize Interleukin-13 (IL-13), a central pathogenic cytokine in AD. A thorough understanding of its structure, mechanism of action, and pharmacokinetic properties is essential to contextualize its clinical efficacy and safety data.
Structure and Physicochemical Properties
Lebrikizumab is a humanized monoclonal antibody, a class of biopharmaceutical products engineered to exhibit high specificity for a single target.[1] It is classified as an immunoglobulin G4 (IgG4) with a kappa light chain.[2] The molecule is a glycoprotein produced via recombinant DNA technology in a mammalian cell expression system, specifically Chinese hamster ovary (CHO) cells.[5]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/05 | Phase 4 | Recruiting | |||
2025/04/10 | Phase 3 | Recruiting | |||
2025/04/02 | Phase 4 | Recruiting | Johann E Gudjonsson MD PhD | ||
2024/07/29 | Phase 3 | Recruiting | |||
2024/06/05 | Phase 3 | Completed | |||
2024/04/01 | Phase 3 | Recruiting | |||
2024/04/01 | Phase 3 | Recruiting | |||
2024/02/28 | Phase 3 | Active, not recruiting | |||
2024/02/06 | Phase 1 | Active, not recruiting | |||
2023/08/14 | Phase 3 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 11/16/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
EBGLYSS SOLUTION FOR INJECTION IN PRE-FILLED PEN 250MG/2ML | SIN17229P | INJECTION, SOLUTION | 250 mg/2 mL | 5/2/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
EBGLYSS SOLUTION FOR INJECTION IN PRE-FILLED PEN 250MG/2ML | N/A | N/A | N/A | 3/24/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
EBGLYSS lebrikizumab 250 mg/2 mL solution for injection autoinjector (pre-filled pen) | 406290 | Medicine | A | 5/29/2024 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
EBGLYSS 250 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1231765001 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico Hospitalario | Commercialized | |
EBGLYSS 250 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1231765007 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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