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1=Etanercept
1=Etanercept is a TNF receptor antagonist (TNF inhibitor) Small molecule drug developed by Amgen. It is currently in Phase 3 development 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.
Etanercept is a medication used to treat conditions such as rheumatoid arthritis, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, and nail psoriasis. It is compared to methotrexate and a placebo in clinical trials, and its efficacy and safety are evaluated in a randomized, double-blind study.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
Amgen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | 1=Etanercept |
|---|---|
| Sponsor | Amgen |
| Drug class | TNF receptor antagonist (TNF inhibitor) |
| Target | TNF-α (Tumor Necrosis Factor-alpha) and TNF-β |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Etanercept consists of the extracellular ligand-binding portion of the human TNF receptor II fused to the Fc region of human IgG1. It acts as a soluble TNF receptor that competitively inhibits TNF-α and TNF-β from binding to cell surface TNF receptors, thereby suppressing TNF-mediated inflammatory responses. This mechanism reduces the activation of immune cells and production of inflammatory mediators in autoimmune and inflammatory conditions.
Approved indications
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Juvenile idiopathic arthritis
- Plaque psoriasis
- Crohn's disease
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Serious infections
- Tuberculosis reactivation
- Demyelinating disease
Key clinical trials
- Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis (PHASE3)
- A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis (PHASE2, PHASE3)
- A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (PHASE3)
- RENAL: TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant (EARLY_PHASE1)
- Stand UP to Rheumatoid Arthritis (SUPRA) (NA)
- Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-Refractory Acute Graft Versus Host Disease (PHASE2)
- Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis (PHASE4)
- Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (PHASE4)
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:
- 1=Etanercept CI brief — competitive landscape report
- 1=Etanercept updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about 1=Etanercept
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What does 1=Etanercept target?
Related
- Drug class: All TNF receptor antagonist (TNF inhibitor) drugs
- Target: All drugs targeting TNF-α (Tumor Necrosis Factor-alpha) 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