Overview
Dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids. It is used to treat or manage a variety of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis (AS), and juvenile idiopathic poly-articular arthritis (JIA).
Indication
Etanercept is indicated for the treatment of moderately to severely active rheumatoid arthritis in adults and in chronic moderate to severe plaque psoriasis in patients 4 years of age and older. It is also used to manage signs and symptoms of polyarticular idiopathic arthritis and Juvenile Psoriatic Arthritis in those aged 2 years and older. Etanercept is also used to manage the symptoms of psoriatic arthritis and ankylosing spondylitis.
Associated Conditions
- Active Juvenile Psoriatic Arthritis
- Ankylosing Spondylitis (AS)
- Graft-versus-host Disease (GVHD)
- Polyarticular Juvenile Idiopathic Arthritis
- Psoriasis Vulgaris (Plaque Psoriasis)
- Psoriatic Arthritis
- Pyoderma Gangrenosum
- Rheumatoid Arthritis
- Severe Plaque psoriasis
- Stevens-Johnson Syndrome
- Chronic, severe Psoriatic Arthritis
- Moderate Plaque psoriasis
- Moderate, active Rheumatoid arthritis
- Severe, active Rheumatoid arthritis
Research Report
Etanercept (DB00005): A Comprehensive Monograph on a Pioneering TNF Inhibitor
Section 1: Molecular Profile and Bioengineering
Etanercept is a cornerstone biologic agent in the treatment of autoimmune diseases, representing a triumph of rational drug design and recombinant DNA technology. Its structure and production method are intricately linked to its therapeutic efficacy, stability, and clinical utility.
1.1. Structural Characterization: An Engineered Dimeric Fusion Protein
Etanercept is a large, complex biomolecule classified as a dimeric fusion protein.[1] It possesses an apparent molecular weight of approximately 150 kilodaltons (kDa) and is composed of two identical polypeptide chains, with each chain comprising 934 amino acids.[1] The defining characteristic of Etanercept is its engineered structure, which is not found in nature. It is created by fusing two distinct and functionally critical human protein domains using recombinant DNA techniques.[5]
The two key components of each polypeptide chain are:
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/27 | Phase 4 | Recruiting | |||
2024/09/19 | Phase 3 | Recruiting | mAbxience Research S.L. | ||
2024/04/30 | Phase 1 | Active, not recruiting | mAbxience Research S.L. | ||
2023/08/29 | N/A | Not yet recruiting | |||
2023/08/25 | Phase 2 | Recruiting | National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland | ||
2023/07/18 | Early Phase 1 | ENROLLING_BY_INVITATION | |||
2022/03/16 | Early Phase 1 | Completed | |||
2021/11/26 | Phase 4 | UNKNOWN | OptiSkin Medical | ||
2021/07/22 | Phase 1 | Completed | |||
2021/01/26 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-3531 | SUBCUTANEOUS | 50 mg in 1 mL | 4/13/2021 | |
| Immunex Corporation | 58406-010 | SUBCUTANEOUS | 25 mg in 0.5 mL | 12/6/2023 | |
| Immunex Corporation | 58406-435 | SUBCUTANEOUS | 50 mg in 1 mL | 12/6/2023 | |
| Immunex Corporation | 58406-456 | SUBCUTANEOUS | 50 mg in 1 mL | 12/6/2023 | |
| Immunex Corporation | 58406-032 | SUBCUTANEOUS | 50 mg in 1 mL | 12/6/2023 | |
| Immunex Corporation | 58406-055 | SUBCUTANEOUS | 25 mg in 0.5 mL | 12/6/2023 | |
| Immunex Corporation | 58406-446 | SUBCUTANEOUS | 50 mg in 1 mL | 12/6/2023 | |
| A-S Medication Solutions | 50090-4490 | SUBCUTANEOUS | 50 mg in 1 mL | 6/20/2019 | |
| Immunex Corporation | 58406-445 | SUBCUTANEOUS | 50 mg in 1 mL | 12/6/2023 | |
| Immunex Corporation | 58406-044 | SUBCUTANEOUS | 50 mg in 1 mL | 12/6/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/2/2000 | ||
Authorised | 6/23/2017 | ||
Authorised | 5/20/2020 | ||
Authorised | 1/13/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Enbrel Solution for Injection in a Pre-Filled Syringe 25mg | SIN13834P | INJECTION, SOLUTION | 50mg/mL | 7/16/2010 | |
| NEPEXTO SOLUTION FOR INJECTION IN PRE-FILLED PEN 50MG/ML | SIN16533P | INJECTION, SOLUTION | 50.0 mg/ml | 7/4/2022 | |
| NEPEXTO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 25 MG/0.5 ML | SIN16531P | INJECTION, SOLUTION | 25.0 mg/0.5ml | 7/4/2022 | |
| Enbrel Solution for Injection in a Pre-filled Syringe 50mg | SIN13835P | INJECTION, SOLUTION | 50mg/mL | 7/16/2010 | |
| NEPEXTO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50 MG/ML | SIN16532P | INJECTION, SOLUTION | 50.0 mg/ml | 7/4/2022 | |
| Enbrel Solution for Injection in a Pre-filled Pen 50mg | SIN14440P | INJECTION, SOLUTION | 50mg/ml | 11/15/2013 | |
| ENBREL FOR INJECTION 25 mg/vial | SIN11854P | INJECTION | 25 mg/vial | 3/23/2002 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Etanercept Solution for Injection | 国药准字SJ20170048 | 生物制品 | 注射剂 | 6/6/2024 | |
| Etanercept Solution for Injection | 国药准字SJ20170049 | 生物制品 | 注射剂 | 6/6/2024 | |
| Etanercept for Injection | 国药准字S20230069 | 生物制品 | 注射剂 | 12/19/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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