MedPath

Lebrikizumab

Generic Name
Lebrikizumab
Brand Names
Ebglyss
Drug Type
Biotech
CAS Number
953400-68-5
Unique Ingredient Identifier
U9JLP7V031

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

Published: Aug 20, 2025

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]

Continue reading the full research report

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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
EBGLYSS
eli lilly canada inc
02549131
Solution - Subcutaneous
250 MG / 2 ML
11/26/2024
EBGLYSS
eli lilly canada inc
02549123
Solution - Subcutaneous
250 MG / 2 ML
9/19/2024

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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