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항목
AntibodyCurated CoreFDAApproved
etanercept (Enbrel, TNFR-Fc)
Amgen / Pfizer·TNF (decoy receptor)
236 trials·t½ 30 h
Overview
Program
Enbrel (etanercept)
Overview
Company
Amgen / Pfizer
Overview
Modality
ANTIBODY
Overview
Target
TNF (decoy receptor)
Overview
Indication
RA, PsA, AS, plaque psoriasis, JIA
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Data Confidence · High
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
novel ADAM17 inhibitor drugs to block soluble TNF-α production in inflammatory diseases
Positioning
Known limitation
Anti-drug antibodies (lower vs mAb TNF inhibitors), non-TNF pathways.
MoA
Mechanism
Etanercept is a dimeric fusion protein of human p75 TNF receptor linked to IgG1 Fc; it binds TNF-α and lymphotoxin-α, preventing receptor activation and downstream NF-κB inflammatory signaling.
MoA
Biomarker
DAS28, PASI, CRP.
PK/PD
Half-life
30 h
PK/PD
Species
Rat, CRP, joint counts, skin scores
PK/PD
Animal (cat.)
Rat, In vitro
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Rat
Toxicology
Major finding
Injection-site reactions, infections, rare demyelination and lupus-like syndrome.
Toxicology
CRS
N/A
Clinical
Safety signal
Injection-site reactions, infections, rare demyelination and lupus-like syndrome.
Clinical
Selected reported efficacy
73.4%
Clinical
PASI75
PASI 75 response rate at Week 12.
Clinical
Result source
ClinicalTrials.gov NCT01891864
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT01891864
Preclinical
Animal (cat.)
Rat