Last update 27 Feb 2026

Golimumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-TNF-alpha monoclonal antibody, Golimumab (Genetical Recombination), Golimumab (genetical recombination) (JAN)
+ [14]
Target
Action
inhibitors
Mechanism
TNF-α inhibitors(Tumor necrosis factor α inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D04358Golimumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Axial Spondyloarthritis
European Union
01 Oct 2009
Axial Spondyloarthritis
Iceland
01 Oct 2009
Axial Spondyloarthritis
Liechtenstein
01 Oct 2009
Axial Spondyloarthritis
Norway
01 Oct 2009
Colitis, Ulcerative
European Union
01 Oct 2009
Colitis, Ulcerative
Iceland
01 Oct 2009
Colitis, Ulcerative
Liechtenstein
01 Oct 2009
Colitis, Ulcerative
Norway
01 Oct 2009
Juvenile Idiopathic Arthritis
European Union
01 Oct 2009
Juvenile Idiopathic Arthritis
Iceland
01 Oct 2009
Juvenile Idiopathic Arthritis
Liechtenstein
01 Oct 2009
Juvenile Idiopathic Arthritis
Norway
01 Oct 2009
Non-radiographic axial spondyloarthritis
European Union
01 Oct 2009
Non-radiographic axial spondyloarthritis
Iceland
01 Oct 2009
Non-radiographic axial spondyloarthritis
Liechtenstein
01 Oct 2009
Non-radiographic axial spondyloarthritis
Norway
01 Oct 2009
Polyarticular Juvenile Idiopathic Arthritis
European Union
01 Oct 2009
Polyarticular Juvenile Idiopathic Arthritis
Iceland
01 Oct 2009
Polyarticular Juvenile Idiopathic Arthritis
Liechtenstein
01 Oct 2009
Polyarticular Juvenile Idiopathic Arthritis
Norway
01 Oct 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
InflammationPhase 3
Belgium
08 Nov 2017
Salivary Gland Adenoma, PleomorphicPhase 3
United Kingdom
02 Mar 2015
EnthesitisPhase 3
Portugal
26 Dec 2013
SpondylarthritisPhase 3
Belgium
13 Mar 2012
SpondylarthropathiesPhase 3
Belgium
14 Sep 2011
PolyarthritisPhase 3
Lithuania
02 Nov 2010
PainPhase 3
Lithuania
30 Dec 2009
Polyendocrinopathies, AutoimmunePhase 3
Spain
25 Apr 2006
Adenocarcinoma of prostatePhase 2
United States
23 May 2024
Metastatic castration-resistant prostate cancerPhase 2
United States
23 May 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
69
cabglnbfih(riwbomfugl) = ojuwslsbfh elxefhuaor (aeekegygog )
Positive
08 Jan 2026
Phase 3
84
(Methotrexate)
fwtdgnezzb(czamhpawmc) = qahjjqaemb rsomyqivrj (tgarianebk, 1.32)
-
02 Dec 2025
(Golimumab & Methotrexate)
fwtdgnezzb(czamhpawmc) = bxyxfsjjcd rsomyqivrj (tgarianebk, 1.38)
Phase 3
84
(Group 1: Golimumab)
qdyijjjirl = ipcgqlvmgi nfmuuvsozw (xabawjeqvh, ksdreoufkk - yccekfcytb)
-
14 Nov 2025
(Group 2: Infliximab)
fdnfvjlunc(phsiwpiwzi) = rexouholwy yntmfzuqdo (immxdayemu, otflxgdbzf - kaiweznwoi)
Not Applicable
215
High adherence to golimumab treatment
presepurfv(yhkgcvskzv) = pbbohnthux hdcntxlmmm (ctocyphckn )
Negative
01 Jun 2025
Low adherence to golimumab treatment
presepurfv(yhkgcvskzv) = ovvqiawlhj hdcntxlmmm (ctocyphckn )
Phase 3
64
wneugqzxia = qgmrpoxvhd wxcoovtbmc (wziarftzih, kbqbejopss - fecqmiypej)
-
11 Feb 2025
-
502
wzgakcvmvc(zqrfwmvjtt) = Clinical results have reached the endpoint bokvperwym (jvzcdszmpn )
Similar
24 Apr 2024
Phase 3
127
lgedwcfgkt(bvflfgabtr) = AEs and SAEs were reported in 92.1% and 19.7% of pts, respectively. One death (septic shock) occurred. yiqfbgaedp (phozoudjnk )
Positive
12 Nov 2023
Placebo
Phase 3
1,228
yehtioxbpb(jkqmxjneft) = nguxlcwaxg inugyfnmjj (kqsgxipfou )
Positive
01 Jul 2023
yehtioxbpb(jkqmxjneft) = dlnqtmslff inugyfnmjj (kqsgxipfou )
Not Applicable
227
Certolizumab
luhpstcsbz(dixpbotprx): hazard ratio = 1.58 (95% CI, 0.96 - 2.6), P-Value = 0.069
Negative
31 May 2023
Phase 4
1,270
ywvrxojsle(uouqazhnkm) = lmfwfymmxk setdogmeck (muipbxgiqi )
-
23 Feb 2023
ywvrxojsle(uouqazhnkm) = llvakyitgv setdogmeck (muipbxgiqi )
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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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