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).
Background
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
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/01/03 | Phase 1 | Terminated | |||
2018/12/19 | Phase 3 | Terminated | |||
2018/12/19 | Phase 2 | Completed | |||
2018/11/02 | Phase 3 | Recruiting | |||
2018/08/28 | Phase 4 | Completed | P. Verschueren | ||
2018/08/17 | Phase 4 | Terminated | |||
2018/04/20 | Phase 4 | UNKNOWN | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2018/03/02 | Phase 3 | Active, not recruiting | |||
2018/01/30 | Phase 3 | Recruiting | |||
2018/01/18 | Phase 3 | UNKNOWN |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||