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Etanercept (ENBREL®)
Etanercept (ENBREL®) is a TNF receptor antagonist Small molecule drug developed by Amgen. It is currently FDA-approved for Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis.
Etanercept is a TNF receptor fusion protein that binds and neutralizes tumor necrosis factor (TNF), a key inflammatory cytokine driving immune-mediated diseases.
Etanercept is a TNF receptor fusion protein that binds and neutralizes tumor necrosis factor (TNF), a key inflammatory cytokine driving immune-mediated diseases. Used for Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis.
At a glance
| Generic name | Etanercept (ENBREL®) |
|---|---|
| Sponsor | Amgen |
| Drug class | TNF receptor antagonist |
| Target | TNF-α and TNF-β |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Etanercept consists of the extracellular ligand-binding domain of the human TNF receptor II fused to the Fc portion of human IgG1. It acts as a soluble TNF receptor that competitively binds circulating TNF-α and TNF-β, preventing their interaction with cell-surface TNF receptors and thereby suppressing the inflammatory cascade. This TNF inhibition reduces immune cell activation and inflammatory cytokine production in autoimmune and inflammatory conditions.
Approved indications
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Polyarticular juvenile idiopathic arthritis
- Plaque psoriasis
- Crohn's disease
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Serious infections (including tuberculosis)
- Demyelinating disorders
- Congestive heart failure exacerbation
Key clinical trials
- Treatment Tapering in JIA With Inactive Disease (PHASE3)
- A Study to Learn About the Adherence and Clinical Outcomes in Colombian Patients With an E-Device for Etanercept Administration in Rheumatoid Arthritis
- Multicenter Randomized Double Blind Controlled-study to Assess the Potential of Methotrexate Versus Placebo to Improve and Maintain Response to Anti TNF- Alpha Agents in Adult Patients With Moderate to Severe Psoriasis (PHASE4)
- Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC (PHASE1)
- A Study Investigating the Safety, Absorption, and Elimination of MB04, a New Compound That May Potentially be Used in the Treatment of Autoimmune Disorders (PHASE1)
- Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD (NA)
- A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis (PHASE3)
- Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Etanercept (ENBREL®) CI brief — competitive landscape report
- Etanercept (ENBREL®) updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about Etanercept (ENBREL®)
What is Etanercept (ENBREL®)?
How does Etanercept (ENBREL®) work?
What is Etanercept (ENBREL®) used for?
Who makes Etanercept (ENBREL®)?
What drug class is Etanercept (ENBREL®) in?
What development phase is Etanercept (ENBREL®) in?
What are the side effects of Etanercept (ENBREL®)?
What does Etanercept (ENBREL®) target?
Related
- Drug class: All TNF receptor antagonist drugs
- Target: All drugs targeting TNF-α and TNF-β
- Manufacturer: Amgen — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Psoriatic arthritis
- Indication: Drugs for Ankylosing spondylitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing