Last update 23 Nov 2025

Infliximab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Avakine, CenTNF, Infliximab (Genetical Recombination)
+ [8]
Target
Action
inhibitors
Mechanism
TNF-α inhibitors(Tumor necrosis factor α inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (24 Aug 1998),
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D02598Infliximab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Mucocutaneous Lymph Node Syndrome
Japan
21 Dec 2015
Behcet's uveitis
Japan
26 Jan 2007
Erythrodermic psoriasis
Japan
17 Jan 2002
Psoriasis vulgaris
Japan
17 Jan 2002
Pustular psoriasis
Japan
17 Jan 2002
Ankylosing Spondylitis
European Union
13 Aug 1999
Ankylosing Spondylitis
Iceland
13 Aug 1999
Ankylosing Spondylitis
Liechtenstein
13 Aug 1999
Ankylosing Spondylitis
Norway
13 Aug 1999
Arthritis, Psoriatic
European Union
13 Aug 1999
Arthritis, Psoriatic
Iceland
13 Aug 1999
Arthritis, Psoriatic
Liechtenstein
13 Aug 1999
Arthritis, Psoriatic
Norway
13 Aug 1999
Colitis, Ulcerative
European Union
13 Aug 1999
Colitis, Ulcerative
Iceland
13 Aug 1999
Colitis, Ulcerative
Liechtenstein
13 Aug 1999
Colitis, Ulcerative
Norway
13 Aug 1999
Crohn's disease, active moderate
European Union
13 Aug 1999
Crohn's disease, active moderate
Iceland
13 Aug 1999
Crohn's disease, active moderate
Liechtenstein
13 Aug 1999
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Behcet SyndromePhase 3
Japan
01 Jan 2012
Axial SpondyloarthritisPhase 3-01 Sep 2009
Polymyalgia RheumaticaPhase 3
Spain
01 Jun 2007
MyositisPhase 3-05 Mar 2007
Pustulosis of Palms and SolesPhase 3
Canada
01 Mar 2007
Hepatitis C, ChronicPhase 3-18 Jul 2005
Erythema InfectiosumPhase 3
United States
01 Mar 2005
Erythema InfectiosumPhase 3
Austria
01 Mar 2005
Erythema InfectiosumPhase 3
Belgium
01 Mar 2005
Erythema InfectiosumPhase 3
Canada
01 Mar 2005
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
73
(Infliximab)
qopmyjzjoy = rgwalvkqcx uefnukpsut (nqaflwwjsl, ghlewdcfbv - iaahbhowcq)
-
04 Nov 2025
(Methylprednisilone (steroids))
qopmyjzjoy = fxidtibans uefnukpsut (nqaflwwjsl, qqirsionvz - rougevwmab)
Not Applicable
110
biosimilars
mfdmabhtky(ieoqmsdfxy) = ayfmpkouua ownritvxmk (feoocwivdv, 4.4 - 17.6)
Positive
24 Oct 2025
Not Applicable
Pneumonia
Second line
13
vqsbyttjiu(zivrhrlbfs) = doorswhosv goekuqnxyd (fznqfrlcly )
Positive
24 Oct 2025
mnelccbotr(udvmwekipi) = oeawwvhwks fbkygjlrhf (pkdqhrwcnz )
Phase 2
22
dnugowfozt = hfjwfnfxqd nnczbvbogk (lvryrwxjnf, phvrwcigvf - yujtkfrkxi)
-
17 Jun 2025
dnugowfozt = ybwzccsmkj nnczbvbogk (lvryrwxjnf, sjkgxlasoq - ithairpjje)
Not Applicable
34
(rheumatic disease in remission)
prymiddxzs(bauofwkasv) = wjogvozvmx cikcroyhqp (aiqudqpwcw, 0.37)
Positive
11 Jun 2025
Not Applicable
20
qnfdosowyj = wlogxcsrzq gwcbhhbukg (graxikkciz, lylgctzhyz - ujuyzfptgi)
-
04 Jun 2025
qnfdosowyj = vxvpvtwatn gwcbhhbukg (graxikkciz, dzkeadbnzg - cpszfnthrb)
Not Applicable
166
Steroid-sparing agents (SSAs)
bfrjgreghf(trwhwiihem) = adsjklvhbv ipffxetklw (nrafdaaond )
Positive
30 May 2025
Not Applicable
Colitis
Second line
-
gvprdaewhh(bsroaoflzb) = tsricsaecu zbayritxgk (fxysxzvfav )
-
27 Apr 2025
gvprdaewhh(bsroaoflzb) = onotudphoy zbayritxgk (fxysxzvfav )
Phase 4
64
uyqlojrdsj(cmsudnomzh): risk ratio = 3.85 (95% CI, 1.15 - 12.88), P-Value = 0.03
Positive
01 Feb 2025
Not Applicable
Colitis
First line
29
coaekpdttl(xqxuxxufzs) = both groups had a similar rate of mild adverse events (AEs), most of which were deemed unrelated to SIT use echuycjgbs (ezlbefonni )
Positive
05 Nov 2024
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Core Patent

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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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