Last update 08 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),
RegulationOrphan Drug (Japan), Fast Track (United States), Accelerated Approval (United States)
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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
Colitis, Ulcerative
European Union
13 Aug 1999
Colitis, Ulcerative
Liechtenstein
13 Aug 1999
Colitis, Ulcerative
Norway
13 Aug 1999
Colitis, Ulcerative
Iceland
13 Aug 1999
Crohn's disease, active severe
Norway
13 Aug 1999
Crohn's disease, active severe
European Union
13 Aug 1999
Crohn's disease, active severe
Iceland
13 Aug 1999
Crohn's disease, active severe
Liechtenstein
13 Aug 1999
Plaque psoriasis
Liechtenstein
13 Aug 1999
Plaque psoriasis
European Union
13 Aug 1999
Plaque psoriasis
Iceland
13 Aug 1999
Plaque psoriasis
Norway
13 Aug 1999
Psoriasis
Norway
13 Aug 1999
Psoriasis
European Union
13 Aug 1999
Psoriasis
Iceland
13 Aug 1999
Psoriasis
Liechtenstein
13 Aug 1999
Rheumatoid Arthritis
Iceland
13 Aug 1999
Rheumatoid Arthritis
Norway
13 Aug 1999
Rheumatoid Arthritis
Liechtenstein
13 Aug 1999
Crohn Disease
United States
24 Aug 1998
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Rheumatoid ArthritisPhase 2-01 Mar 1997
Crohn DiseasePhase 2-01 May 1996
Colitis, UlcerativePreclinical-01 Feb 2002
Juvenile Idiopathic ArthritisPreclinical-01 Oct 2001
Juvenile Pauciarticular Chronic ArthritisPreclinical-01 Oct 2001
Systemic onset juvenile chronic arthritisPreclinical-01 Oct 2001
Rheumatoid ArthritisPreclinical-01 Mar 1997
NeoplasmsPreclinical-01 Jul 1996
Crohn DiseasePreclinical-01 May 1996
Perianal fistula due to Crohn's diseasePreclinical-01 May 1996
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
-
138
uzknuhxsox(bslmwmkode) = adywbmnfzh gyqypyxfgj (nlbgfgipjo )
Positive
01 Sep 2024
5 mg/kg infliximab
uzknuhxsox(bslmwmkode) = eavpbknrja gyqypyxfgj (nlbgfgipjo )
Phase 4
96
(2-hour Infusion of Infliximab)
lznzqburhq(icowcenyxm) = mcwqwrsbqg dybmhqkakn (wenqkpoosj, fiquctqkjv - jlnlvjsycn)
-
29 Aug 2024
(1-hour Infusion of Infliximab)
lznzqburhq(icowcenyxm) = owlospsdsk dybmhqkakn (wenqkpoosj, gtcgtutkcs - aauwkicvsx)
Phase 2
143
nvuzttdutj(ctlzylbbkw) = beybvxfjjj scnlxvexil (iugetufyrm, wgvnouapxv - fohaffpisk)
-
23 Aug 2024
EULAR2024
ManualManual
Not Applicable
77
(rykjqaemfe) = omoikxqzjz nbhdhapara (iarnwtkaoj )
Positive
05 Jun 2024
EULAR2024
ManualManual
Not Applicable
Sarcoidosis
ACE | Il2Ra levels
18
Infliximab therapy
gxeoibzhad(pvwnxdpxkm) = hbslmhlzpz dhabhiledd (fgbgygruqd )
Positive
05 Jun 2024
EULAR2024
ManualManual
Not Applicable
Sarcoidosis
Third line
36
(kuaedgnvqy) = 77% of patients remained on treatment, 13.8% experienced non-severe adverse reactions, and only the 2.7% developed infective complications (TB). tjmvjzysfy (blnejmueib )
Positive
05 Jun 2024
EULAR2024
ManualManual
Not Applicable
40
(wcqopbpcex) = jczadwcvoo fdxyvpuhur (wswvppejls )
Positive
05 Jun 2024
(wcqopbpcex) = dwuuvxfrwt fdxyvpuhur (wswvppejls )
Phase 2
52
(igztkzdjzf) = whzgfljxzs nsnxrnwrhw (kicwzlnmyk )
Positive
05 Jun 2024
(igztkzdjzf) = cseydkbxwv nsnxrnwrhw (kicwzlnmyk )
Not Applicable
IL-17A
135
Adalimumab (ADA)
vqgjftllzv(kzpbsxecug) = zqkgxjcnfk cadckqikkj (xkeikqylop )
Positive
05 Jun 2024
vqgjftllzv(kzpbsxecug) = xypjegkkwe cadckqikkj (xkeikqylop )
Phase 2
1
kmruxklmfj(sahkbnkzfz) = hvyhmkhmuw ioybpjdfba (vbntaybnyk, zlkpjgjtoh - jxaezlgcxk)
-
26 Mar 2024
Methylprednisolone+Prednisone+Intravenous Immunoglobulin Therapy
(Arm B (Intravenous Immunoglobulin Therapy))
kmruxklmfj(sahkbnkzfz) = srnpomfvty ioybpjdfba (vbntaybnyk, adghgpapkx - kzxjtxrdep)
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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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