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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
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 | |||
2021/10/15 | Phase 4 | Completed | Jeffrey Curtis |
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 |
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 |
|---|---|---|---|---|---|
| Ixekizumab Injection | 国药准字SJ20190034 | 生物制品 | 注射剂 | 9/10/2024 |
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 |
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