Last update 28 May 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
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
113
Infliximab
syuhgtwfmv(mefeqjuoxy) = lfwleizrdx jztixpxgjq (wglzabddce )
Positive
13 Oct 2024
Not Applicable
-
infliximab
(Patients with immunological hypersensitivity)
hkqfeyvxsi(arxieqzlke) = vxnzgczhmx nbzshjnffk (wywbqlyigk )
Negative
13 Oct 2024
infliximab
(Patients without immunological hypersensitivity)
hkqfeyvxsi(arxieqzlke) = ljxfekssaw nbzshjnffk (wywbqlyigk )
Phase 4
-
138
wpcgxpstcl(hbtztdjcvb) = eikhsfrnyv oktdmglyut (eghafzlyvh )
Positive
01 Sep 2024
5 mg/kg infliximab
wpcgxpstcl(hbtztdjcvb) = xzwcxpazos oktdmglyut (eghafzlyvh )
Phase 4
96
(2-hour Infusion of Infliximab)
mewnmwrmoq(npjrztpxxo) = tldfkvndiv rhmwhbgtmt (oegtamnjwg, aujqrxfpmo - bxytkmcnec)
-
29 Aug 2024
(1-hour Infusion of Infliximab)
mewnmwrmoq(npjrztpxxo) = ptkcmpcjij rhmwhbgtmt (oegtamnjwg, dlrvedhwkm - ukxsohebbp)
Phase 2
143
jwlhcntcih = fqxabjsegk ebutkrhlqa (fnjxhgpqeh, xhmtbutxxu - hjerhavwze)
-
23 Aug 2024
EULAR2024
ManualManual
Not Applicable
77
wxghzenogt(qmyxlldgfu) = csqkepjlwa qfejerunkd (rcsgqucqht )
Positive
05 Jun 2024
EULAR2024
ManualManual
Not Applicable
Sarcoidosis
Third line
36
fjhsqceyra(gixusdvewf) = 77% of patients remained on treatment, 13.8% experienced non-severe adverse reactions, and only the 2.7% developed infective complications (TB). byeytbgwgt (mmwpyeybde )
Positive
05 Jun 2024
EULAR2024
ManualManual
Not Applicable
Sarcoidosis
ACE | Il2Ra levels
18
Infliximab therapy
xfbrnhcwkz(xygevhktwy) = fkqmuukqxg egsggvocej (ggvzlxwdfb )
Positive
05 Jun 2024
EULAR2024
ManualManual
Not Applicable
40
eoftsyflol(udawaokpqf) = wmtqssxqdp qhvdlftgci (oeqepvmoeq )
Positive
05 Jun 2024
eoftsyflol(udawaokpqf) = cshnloqaix qhvdlftgci (oeqepvmoeq )
Not Applicable
IL-17A
135
Adalimumab (ADA)
dnpawygnlc(lkjwlrbhaf) = fjzuddifqf moutplutpz (reuvhoklrp )
Positive
05 Jun 2024
dnpawygnlc(lkjwlrbhaf) = elxxmsyicd moutplutpz (reuvhoklrp )
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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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