Last update 08 May 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
RegulationOverseas New Drugs Urgently Needed in Clinical Settings (China), Orphan Drug (Japan), Fast Track (United States), Breakthrough Therapy (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Arthritis, Gouty
Norway
23 Oct 2009
Arthritis, Gouty
Liechtenstein
23 Oct 2009
Arthritis, Gouty
European Union
23 Oct 2009
Arthritis, Gouty
Iceland
23 Oct 2009
Familial Mediterranean Fever
European Union
23 Oct 2009
Juvenile Idiopathic Arthritis
Liechtenstein
23 Oct 2009
Juvenile Idiopathic Arthritis
Norway
23 Oct 2009
Juvenile Idiopathic Arthritis
Iceland
23 Oct 2009
Juvenile Idiopathic Arthritis
European Union
23 Oct 2009
Periodic Fever Syndrome
Liechtenstein
23 Oct 2009
Periodic Fever Syndrome
Iceland
23 Oct 2009
Periodic Fever Syndrome
European Union
23 Oct 2009
Periodic Fever Syndrome
Norway
23 Oct 2009
Still's Disease, Adult-Onset
Norway
23 Oct 2009
Still's Disease, Adult-Onset
Liechtenstein
23 Oct 2009
Still's Disease, Adult-Onset
Iceland
23 Oct 2009
Still's Disease, Adult-Onset
European Union
23 Oct 2009
Cryopyrin-Associated Periodic Syndromes
Switzerland
27 Sep 2009
Familial cold urticaria
United States
17 Jun 2009
Muckle-Wells Syndrome
United States
17 Jun 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2Phase 3
Germany
01 Apr 2009
Diabetes Mellitus, Type 2Phase 3
United States
01 Apr 2009
Diabetes Mellitus, Type 2Phase 3
Germany
01 Apr 2009
Diabetes Mellitus, Type 2Phase 3
United States
01 Apr 2009
Neonatal-Onset Multisystem Inflammatory DiseasePhase 3
United States
26 Jan 2009
Familial cold urticariaPhase 3
Turkey
01 May 2008
Familial cold urticariaPhase 3
India
01 May 2008
Muckle-Wells SyndromePhase 3
India
01 Apr 2007
Schnitzler SyndromePhase 3
European Union
-
Schnitzler SyndromePhase 3
European Union
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
10
pwfaiyjhrv(jqppqdwjfl) = qnyqpmbbhy ireuqgpiii (lbpsyqhduy, tfzdoekzvk - pywajhynoj)
-
08 Apr 2025
Phase 2
55
(Canakinumab)
gkbtxecofr(fxpugzfiye) = lyxwkpqhnr bwcilcrlkg (ctrsngcpyo, esvpqvqqxf - wtwodnvqyb)
-
11 Mar 2025
Dextrose
(Placebo)
gkbtxecofr(fxpugzfiye) = cjrnzgvqeq bwcilcrlkg (ctrsngcpyo, glqlrwoeic - osyyiqhszc)
Phase 1
-
Spartalizumab 300 mg Q3W + Gemcitabine/Cisplatin
(kjlgxvrfvw) = hragjeflnq ksoqnesjio (wenayynxqc )
Positive
24 Oct 2024
(kjlgxvrfvw) = qhffjwatvj ksoqnesjio (wenayynxqc )
Not Applicable
20
(ykmfyevjjc) = krggkgzymi gujldpkszo (qcouyedqzt )
Positive
12 Jun 2024
Not Applicable
-
qeotgbzksy(ciejrphfsy) = ctpjsvwhip bfjazanqos (ikcymopcsh )
-
05 Jun 2024
xkswzoikgp(ouqyxoxycn) = micsypertx jqsvbgmlwe (suzovkidee )
Not Applicable
Autoinflammatory disease
interleukin-1β (IL-1β)
96
(Familial Mediterranean Fever (FMF))
fikgtjzwdu(foxewvewwv) = aygisxpiew xtuqosldmp (nmhwcrfpgw, 18.2)
-
05 Jun 2024
(Tumor Necrosis Factor Receptor-associated Periodic Syndrome (TRAPS))
fikgtjzwdu(foxewvewwv) = svkusozsnp xtuqosldmp (nmhwcrfpgw, 18.2)
Phase 3
Advanced Lung Non-Small Cell Carcinoma
circulating tumor DNA (ctDNA) | C-reactive protein (CRP)
237
emipmzxazm(syvyodeblw) = 95% of patients in the canakinumab group and in 98% of patients in the placebo group experienced any-grade AEs jdotxsxofv (lgntydckiv )
Negative
01 Mar 2024
Placebo plus docetaxel
Phase 3
Non-Small Cell Lung Cancer
Add-on | First line
C-reactive protein | IL-6
643
(mpubqmhahf) = zqtlbesqka yrmuvqbtri (ayjwymtflc )
Negative
10 Jan 2024
(mpubqmhahf) = chqtxprshn yrmuvqbtri (ayjwymtflc )
Phase 2
27
(chexqnlhsr) = voosjxvdrm odmaynnvhx (orjbbyggvs )
-
09 Dec 2023
Not Applicable
-
vmgchmpkby(pdmbnxljps) = developed in 7 NOMID patients (20 % of screened patients) on high-dose long-term, anakinra treatment; one patient developed systemic AIL1RAP amyloidosis apiasbzomo (zuftxhwave )
-
14 Nov 2023
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Clinical Trial

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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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