MedPath

Ixekizumab

Generic Name
Ixekizumab
Brand Names
Taltz
Drug Type
Biotech
CAS Number
1143503-69-8
Unique Ingredient Identifier
BTY153760O

Overview

Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) against interleukin-17A (IL-17A) and prevents it from interacting with the IL-17A receptor. As IL-17A is a pro-inflammatory cytokine involved in inflammation and immune responses, blocking its effect is beneficial for use in inflammatory conditions. In particular, IL-17A has been found to be implicated in a variety of autoimmune diseases including Rheumatoid Arthritis and plaque psoriasis. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each, and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. It is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Indication

Ixekizumab is indicated for the treatment of patients aged six years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is also indicated in adult patients with active psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis with objective signs of inflammation.

Associated Conditions

  • Moderate to Severe Plaque Psoriasis
  • Active Ankylosing spondylitis
  • Active Non-radiographic Axial Spondyloarthritis
  • Active Psoriatic arthritis

Research Report

Published: Aug 3, 2025

Ixekizumab (Taltz®): A Comprehensive Monograph on its Pharmacology, Clinical Efficacy, and Safety Profile

Section 1: Introduction and Drug Profile

1.1. Overview and Therapeutic Classification

Ixekizumab is a high-affinity, humanized monoclonal antibody that represents a significant advancement in the targeted treatment of several chronic, immune-mediated inflammatory diseases.[1] Marketed under the brand name Taltz®, it is classified as a biologic therapy, specifically an interleukin inhibitor, that functions by selectively targeting and neutralizing the pro-inflammatory cytokine Interleukin-17A (IL-17A).[3] Its development and application are rooted in the growing understanding of the central role of the T helper 17 (Th17) cell pathway in the pathophysiology of conditions such as moderate-to-severe plaque psoriasis, active psoriatic arthritis, active ankylosing spondylitis, and active non-radiographic axial spondyloarthritis.[1]

The precise classification of Ixekizumab as an "Interleukin-17A Antagonist" is a critical distinction that reflects a strategic evolution in the design of biologic drugs. The IL-17 family of cytokines includes several members (IL-17A, B, C, D, E, and F), each with potentially distinct biological roles.[10] Early research identified the IL-17A isoform as the primary pathogenic driver in the targeted inflammatory conditions.[1] Consequently, Ixekizumab was engineered with high specificity to bind and neutralize only IL-17A, including its homodimeric (IL-17A/A) and heterodimeric (IL-17A/F) forms, without interacting with other family members.[10] This targeted approach contrasts with broader immunosuppressive agents, such as conventional disease-modifying antirheumatic drugs (DMARDs) or even first-generation biologics like tumor necrosis factor-alpha (TNF-α) inhibitors, which have a more widespread impact on the immune system. It also differs from other biologics that might target the IL-17 receptor, a

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/24
Not Applicable
Not yet recruiting
2025/04/25
Phase 3
Recruiting
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
2025/02/06
Not Applicable
Not yet recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
2025/01/22
N/A
Recruiting
2024/09/19
Phase 3
Active, not recruiting
2024/09/19
Phase 3
Active, not recruiting
2024/04/19
Phase 2
Not yet recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
2023/10/16
Phase 4
Recruiting
Massachusetts Eye Research and Surgery Institution
2023/05/12
Phase 4
Completed
2022/04/04
Phase 2
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Eli Lilly and Company
0002-8905
SUBCUTANEOUS
40 mg in 0.5 mL
2/2/2024
Eli Lilly and Company
0002-8900
SUBCUTANEOUS
20 mg in 0.25 mL
2/2/2024
Eli Lilly and Company
0002-7724
SUBCUTANEOUS
80 mg in 1 mL
2/2/2024
Eli Lilly and Company
0002-1445
SUBCUTANEOUS
80 mg in 1 mL
2/2/2024

EMA Drug Approvals

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
TALTZ SOLUTION FOR INJECTION IN PRE-FILLED PEN 80 mg/ml
SIN15501P
INJECTION, SOLUTION
80 mg/ml
6/6/2018

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.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
TALTZ
eli lilly canada inc
02455102
Solution - Subcutaneous
80 MG / ML
8/11/2016
TALTZ
eli lilly canada inc
02455110
Solution - Subcutaneous
80 MG / ML
8/11/2016

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
TALTZ 80 mg SOLUCION INYECTABLE EN PLUMA PRECARGADA
Eli Lilly And Co (Ireland) Limited
1151085001
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Diagnóstico Hospitalario
Commercialized
TALTZ 80 mg SOLUCION INYECTABLE EN JERINGA PRECARGADA
Eli Lilly And Co (Ireland) Limited
1151085004
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.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.