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Etanercept Liquid
Etanercept Liquid is a TNF receptor antagonist 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 TNF receptor fusion protein that binds and neutralizes tumor necrosis factor (TNF), a key inflammatory cytokine. Used for Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis.
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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 | Etanercept Liquid |
|---|---|
| Sponsor | Amgen |
| Drug class | TNF receptor antagonist |
| Target | TNF-α 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 inflammation and immune activation 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
- Tuberculosis reactivation
Key clinical trials
- Safety and Efficacy Study of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis (PHASE3)
- Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept (PHASE3)
- Limitation of Ischemic Injury of a Kidney Stored in Machine Perfusion in Hypothermia - Evaluation of the Impact on Kidney Allograft Function (PHASE2)
- Safety and Pharmacokinetic Characteristics of HD203 Liquid in Healthy Male Volunteers (PHASE1)
- Compare Actions in Healthy Volunteer of 50 mg Etanercept Injection Using an Auto-injector Device and Manual Injection (PHASE1)
- Open-label Study Using 50 Mg Liquid Etanercept Subcutaneous Injection in the Thigh to Compare an Auto-injector Device and a Manual Injection in Healthy Subjects (PHASE1)
- Treatment for Subjects With Active Rheumatoid Arthritis (RA) (PHASE3)
- Enbrel Liquid Immunogenicity 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 Liquid CI brief — competitive landscape report
- Etanercept Liquid updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about Etanercept Liquid
What is Etanercept Liquid?
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What development phase is Etanercept Liquid in?
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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