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
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
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
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 4/25/2016 | ||
Authorised | 4/25/2016 |
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. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
TALTZ ixekizumab 80 mg/mL solution for injection prefilled syringe | 253892 | Medicine | A | 9/6/2016 | |
TALTZ ixekizumab 80 mg/mL solution for injection prefilled syringe | 414413 | Medicine | A | 8/15/2024 | |
TALTZ ixekizumab 80 mg/mL solution for injection prefilled pen | 253893 | Medicine | A | 9/6/2016 | |
TALTZ ixekizumab 80 mg/mL solution for injection prefilled pen | 414414 | Medicine | A | 8/15/2024 |
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. |
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