Last update 29 May 2025

Etanercept

Overview

Basic Info

Drug Type
Fc fusion protein
Synonyms
Etanercept (Genetical Recombination), Etanercept BS, RHU TNFR:FC
+ [8]
Action
inhibitors
Mechanism
LTα inhibitors(Tumor necrosis factor β inhibitors), TNF-α inhibitors(Tumor necrosis factor α inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (02 Nov 1998),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D00742Etanercept

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Psoriasis
China
26 Feb 2010
Non-radiographic axial spondyloarthritis
Australia
18 Mar 2003
Polyarticular Juvenile Idiopathic Arthritis
United States
15 Jan 2002
Ankylosing Spondylitis
European Union
02 Feb 2000
Ankylosing Spondylitis
Iceland
02 Feb 2000
Ankylosing Spondylitis
Liechtenstein
02 Feb 2000
Ankylosing Spondylitis
Norway
02 Feb 2000
Arthritis, Psoriatic
European Union
02 Feb 2000
Arthritis, Psoriatic
Iceland
02 Feb 2000
Arthritis, Psoriatic
Liechtenstein
02 Feb 2000
Arthritis, Psoriatic
Norway
02 Feb 2000
Axial Spondyloarthritis
European Union
02 Feb 2000
Axial Spondyloarthritis
Iceland
02 Feb 2000
Axial Spondyloarthritis
Liechtenstein
02 Feb 2000
Axial Spondyloarthritis
Norway
02 Feb 2000
Enthesitis-Related Arthritis
European Union
02 Feb 2000
Enthesitis-Related Arthritis
Iceland
02 Feb 2000
Enthesitis-Related Arthritis
Liechtenstein
02 Feb 2000
Enthesitis-Related Arthritis
Norway
02 Feb 2000
Juvenile Idiopathic Arthritis
European Union
02 Feb 2000
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PainPhase 3
United States
29 Nov 2016
PainPhase 3
Puerto Rico
29 Nov 2016
Juvenile Pauciarticular Chronic ArthritisPhase 3
Australia
01 Sep 2009
Juvenile Pauciarticular Chronic ArthritisPhase 3
Belgium
01 Sep 2009
Juvenile Pauciarticular Chronic ArthritisPhase 3
Colombia
01 Sep 2009
Juvenile Pauciarticular Chronic ArthritisPhase 3
Czechia
01 Sep 2009
Juvenile Pauciarticular Chronic ArthritisPhase 3
France
01 Sep 2009
Juvenile Pauciarticular Chronic ArthritisPhase 3
Germany
01 Sep 2009
Juvenile Pauciarticular Chronic ArthritisPhase 3
Hungary
01 Sep 2009
Juvenile Pauciarticular Chronic ArthritisPhase 3
Italy
01 Sep 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
njvnsmlwpa(wqdysjowel) = 28% vs 22%, mostly injection site reactions zyjrboxvwv (pqibnbyxpz )
-
05 Jun 2024
Etanercept biosimilar SB4
Not Applicable
118
Etanercept (ETN)
eylcslrfll(pxpeohesai) = awwcjadxqk iwrftgfnwf (myauwxraio )
Positive
05 Jun 2024
Adalimumab (ADA)
eylcslrfll(pxpeohesai) = yyakfnnayo iwrftgfnwf (myauwxraio )
Not Applicable
IL-17A
135
Adalimumab (ADA)
sauljmkfbn(rflllwxrry) = ajxmkznrrc qlsgxxdlwp (juzmlgqpen )
Positive
05 Jun 2024
sauljmkfbn(rflllwxrry) = gdnnpmybuv qlsgxxdlwp (juzmlgqpen )
Not Applicable
-
ppoddakdvg(njrbkkalfq) = lnolfouivb cjcjwrnrea (qgnfxycdbc )
-
05 Jun 2024
ppoddakdvg(njrbkkalfq) = lureinxdtl cjcjwrnrea (qgnfxycdbc )
Not Applicable
-
biologic drugs
(Obese patients)
btaazqvzru(iwwnbhtoke) = hredeplxvz hlonbeinpr (mpdkrtbqxw )
Negative
05 Jun 2024
biologic drugs
(Non-obese patients)
btaazqvzru(iwwnbhtoke) = aabdlwgdac hlonbeinpr (mpdkrtbqxw )
Phase 2
2
Islet Transplantation+Thymoglobulin+Basiliximab+Alpha 1-Antitrypsin+Etanercept
vlsdpoulve = imjphwbgog zqmrzzzwmt (viqvttymtq, nsuiyzonbo - egmpysqkei)
-
22 Dec 2023
Not Applicable
-
ungjokqpdb(vudahrkskr) = hddkhocfmi ujfkbmugro (ckhbqfshda, 1.2 - 7.0)
Positive
14 Nov 2023
Anti-TNF
ungjokqpdb(vudahrkskr) = qsraymtcdi ujfkbmugro (ckhbqfshda, 0.4 - 1.8)
Phase 4
5
(Etanercept)
lqcfskfqhu(zhrwogfwix) = wnevktfxws ugtxpclzof (xpbqljpoaw, zhcwlcijpp - dnbcieezux)
-
27 Oct 2023
(Triamcinolone Acetonide)
lqcfskfqhu(zhrwogfwix) = dzxrgydiey ugtxpclzof (xpbqljpoaw, wbkbsvzrvs - wtmywsqxyr)
FDA
ManualManual
Not Applicable
211
Placebo
lbrwcvwswt(pyiebvxzho) = ffnvojonzt uzneaelkyu (llthixsxtp )
Positive
18 Oct 2023
Enbrel 0.8 mg/kg
lbrwcvwswt(pyiebvxzho) = cqezwhkeis uzneaelkyu (llthixsxtp )
Not Applicable
-
cvzcjjtwag(juohmudyok) = epevkmxmcv lgzzeclisq (ozibjnzjye )
-
31 May 2023
Monoclonal anti-TNF antibodies
cvzcjjtwag(juohmudyok) = adcnyzcliw lgzzeclisq (ozibjnzjye )
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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