MedPath

Tralokinumab

Generic Name
Tralokinumab
Brand Names
Adbry, Adtralza
Drug Type
Biotech
CAS Number
1044515-88-9
Unique Ingredient Identifier
GK1LYB375A

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

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/01/14
Phase 4
Active, not recruiting
Psoriasis Treatment Center of Central New Jersey
2024/10/07
Phase 2/3
Recruiting
2023/07/24
Phase 3
Recruiting
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.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ADTRALZA
02521288
Solution - Subcutaneous
150 MG / ML
3/17/2022
ADTRALZA
02540193
Solution - Subcutaneous
300 MG / 2 ML
6/3/2024

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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