Overview
Atopic dermatitis (AD) is an inflammatory skin disorder that causes skin inflammation, skin barrier dysfunction, and chronic pruritus. It is estimated to affect up to 20% of adults and children worldwide, and is frequently associated with other atopic conditions such as asthma or allergic rhinitis. While AD is a heterogenous condition with a variety of apparent genetic and environmental causes, it is primarily driven by the pro-inflammatory cytokine interleukin-13 (IL-13). Tralokinumab is a fully human IgG4 monoclonal antibody targeted against IL-13. It neutralizes IL-13 activity by inhibiting its ability to bind with receptors, thus helping to alleviate AD symptoms. Tralokinumab was first approved for the treatment of atopic dermatitis by the EMA in June 2021, under the brand name Adtralza (Leo Pharma), and was subsequently approved in Canada in October 2021 and the US in December 2021.
Indication
Tralokinumab is indicated in Canada, the US, and the EU for the treatment of moderate-to-severe atopic dermatitis in patients who are candidates for systemic therapy and are inadequately controlled with topical interventions. In Canada and US, tralokinumab is only approved for adults. In Europe, it is approved for use in patients 12 years of age and older.
Associated Conditions
- Moderate to Severe Atopic Dermatitis
Research Report
Tralokinumab: A Comprehensive Monograph on a Targeted IL-13 Inhibitor for Atopic Dermatitis
Executive Summary
Tralokinumab is a first-in-class, fully human immunoglobulin G4 (IgG4) monoclonal antibody that represents a significant advancement in the targeted treatment of atopic dermatitis (AD).[1] Marketed under the brand names Adbry® and Adtralza®, it is indicated for the treatment of moderate-to-severe AD in adult and adolescent patients (aged 12 years and older) who are candidates for systemic therapy.[3] The therapeutic action of tralokinumab is predicated on its high-affinity, specific binding to the interleukin-13 (IL-13) cytokine, a key driver of the Type 2 inflammation that underpins AD pathogenesis. By neutralizing IL-13, tralokinumab prevents its interaction with the IL-13Rα1/IL-4Rα receptor complex, thereby inhibiting the downstream signaling cascade responsible for skin barrier dysfunction, inflammation, and pruritus.[2]
The clinical efficacy and safety of tralokinumab were robustly established in the comprehensive ECZTRA Phase 3 clinical trial program. In pivotal monotherapy trials (ECZTRA 1 and 2), tralokinumab demonstrated statistically significant and clinically meaningful improvements in skin clearance, as measured by the Investigator's Global Assessment (IGA) score, and in disease severity, assessed by a 75% or greater improvement in the Eczema Area and Severity Index (EASI-75), compared to placebo at 16 weeks.[7] Efficacy was also demonstrated when used in combination with topical corticosteroids (ECZTRA 3) and in the adolescent population (ECZTRA 6), with long-term data from the ECZTEND extension study confirming durable responses and a consistent safety profile over several years of treatment.[5]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/14 | Phase 4 | Active, not recruiting | Psoriasis Treatment Center of Central New Jersey | ||
2024/03/15 | Phase 2/3 | Recruiting | |||
2023/07/24 | Phase 3 | Completed | |||
2023/07/10 | N/A | Recruiting | |||
2022/05/24 | Phase 2 | Active, not recruiting | |||
2022/01/18 | Phase 3 | Completed | |||
2020/12/19 | Phase 1 | Completed | |||
2020/10/14 | Phase 3 | Completed | |||
2020/09/21 | Phase 2 | Completed | Prof. Dr. Stephan Weidinger | ||
2018/12/03 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| LEO Pharma Inc. | 50222-346 | SUBCUTANEOUS | 150 mg in 1 mL | 12/14/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/17/2021 | ||
Authorised | 6/17/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| 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. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ADTRALZA 150 mg SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1211554002 | SOLUCIÓN INYECTABLE | Diagnóstico Hospitalario | Commercialized | |
| ADTRALZA 300 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1211554004 | SOLUCIÓN INYECTABLE | 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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