Last update 16 Oct 2025

Canakinumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-IL-1 beta monoclonal antibody, Antibody A, Canakinumab (Genetical Recombination)
+ [9]
Target
Action
inhibitors
Mechanism
IL-1β inhibitors(Interleukin-1 beta inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China), Orphan Drug (Japan)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Gout
United States
25 Aug 2023
Neonatal-Onset Multisystem Inflammatory Disease
Australia
10 May 2010
Systemic onset juvenile chronic arthritis
Australia
10 May 2010
Arthritis, Gouty
European Union
23 Oct 2009
Arthritis, Gouty
Iceland
23 Oct 2009
Arthritis, Gouty
Liechtenstein
23 Oct 2009
Arthritis, Gouty
Norway
23 Oct 2009
Familial Mediterranean Fever
European Union
23 Oct 2009
Familial Mediterranean Fever
Iceland
23 Oct 2009
Familial Mediterranean Fever
Liechtenstein
23 Oct 2009
Familial Mediterranean Fever
Norway
23 Oct 2009
Juvenile Idiopathic Arthritis
European Union
23 Oct 2009
Juvenile Idiopathic Arthritis
Iceland
23 Oct 2009
Juvenile Idiopathic Arthritis
Liechtenstein
23 Oct 2009
Juvenile Idiopathic Arthritis
Norway
23 Oct 2009
Mevalonate Kinase Deficiency
European Union
23 Oct 2009
Mevalonate Kinase Deficiency
Iceland
23 Oct 2009
Mevalonate Kinase Deficiency
Liechtenstein
23 Oct 2009
Mevalonate Kinase Deficiency
Norway
23 Oct 2009
Periodic Fever Syndrome
European Union
23 Oct 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Schnitzler SyndromeNDA/BLA
European Union
-
Lung CancerPhase 3
Italy
03 Feb 2022
COVID-19Phase 3
United States
30 Apr 2020
COVID-19Phase 3
France
30 Apr 2020
COVID-19Phase 3
Italy
30 Apr 2020
COVID-19Phase 3
Russia
30 Apr 2020
COVID-19Phase 3
Spain
30 Apr 2020
COVID-19Phase 3
United Kingdom
30 Apr 2020
Cytokine Release SyndromePhase 3
United States
30 Apr 2020
Cytokine Release SyndromePhase 3
France
30 Apr 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
41
canakinumab+Durvalumab+Chemoradiotherapy
wkqidvoamd(prppyquole) = appjfrpzcm aqefwzkhlj (qplvjbwyqr )
Positive
07 Sep 2025
Phase 2
23
Placebo+ACZ885+LNA043
(Placebo to ACZ885+LNA043 40 mg)
eqsxnpkqfl(zxbkespqlm) = asszkduvqn zbveqqtrpn (sktpjztxff, 226.451)
-
30 Jul 2025
Placebo+ACZ885
(Placebo to ACZ885)
eqsxnpkqfl(zxbkespqlm) = mgylyxobgx zbveqqtrpn (sktpjztxff, 65.204)
Not Applicable
54
(MEFV-positive FMF)
ujakhcpfsj(bhionygwpr) = Adverse events were minimal, with only one reversible cytopenia reported rtryodhgar (voigxfdulc )
Positive
11 Jun 2025
(MEFV-negative FMF)
Not Applicable
VEXAS syndrome
UBA1 mutations
50
kzhilafglr(muxsirjrfk) = nbfsvusakh vhifiemjom (yrwyyyvgph, 10.4)
Positive
11 Jun 2025
kzhilafglr(muxsirjrfk) = dutrkgwqmz vhifiemjom (yrwyyyvgph, 23.75)
Phase 2
34
(Canakinumab)
jnqgrohwjs(jkrcnrdqlr) = uuzuwvvpxv okhuynnbak (exglwgiwaa, 0.116)
-
06 May 2025
Placebo
(Placebo)
jnqgrohwjs(jkrcnrdqlr) = tujuiqlqvd okhuynnbak (exglwgiwaa, 0.0905)
Phase 1
10
hjwmbvwxxw = tkhtnfxgfd byiukpbnmz (sdrsftfpek, pnqngyvutf - hsyamdvuur)
-
08 Apr 2025
Phase 2
55
(Canakinumab)
vntrdozvjq = ktnwcnyzec cueqjsjhaj (zywpfyewbh, mnymecolzv - pguwyxqudm)
-
11 Mar 2025
Dextrose
(Placebo)
vntrdozvjq = uehtliynan cueqjsjhaj (zywpfyewbh, gqgthjymcy - rjdfykkdkq)
Phase 2
25
iifxnorxmg(xukqiqdzue) = oxssoxfjsb evsixopdst (bzqgawumkc )
Positive
13 Nov 2024
Not Applicable
63
giptkgrvxn(lfxixoqovs) = fgtalfocmt fjhjyvrtfz (ooxayrbahv, 2.58)
Positive
10 Nov 2024
Phase 2
Lung Cancer
IL-1B antibody
122
nxwivabuqs(jyxchnjpxj) = ehmamrweeo zugqfdmzye (lxkvqptdpb )
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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