Canakinumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2009
- First approval year
- 2009
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Canakinumab
- ilaris
- Ilaris
- acz 885
- ACZ-885
- acz885
- ACZ885
- ACZ885 (investigational)
- ACZ885 150 mg (Canakinumab)
- canakinumab
- Canakinumab
- canakinumab (company code: ACZ885D)
- CANAKINUMAB (ILARIS®)
- Canakinumab (investigational)
- CANAKINUMAB [EMA EPAR]
- canakinumab [INN]
- CANAKINUMAB [JAN]
- CANAKINUMAB [MART.]
- CANAKINUMAB [MI]
- CANAKINUMAB [PURPLE BOOK CDER]
- CANAKINUMAB [USAN]
- CANAKINUMAB [VANDF]
- Canakinumab [WHO-DD]
- Canakinumab 150 mg
- canakinumab ema epar
- Canakinumab Injection
- Canakinumab Injection 300mg
- Canakinumab Injection 600mg
And 16 more, listed on the interactive page.
- ATC classification codes
- L04AC08
Sources for recorded values
- CAS registry numbers
- 914613-48-2
- ChEMBL ID
- CHEMBL1201834
- RxNorm IDs (RxCUI)
- 853491
- FDA ingredient codes (UNII)
- 37CQ2C7X93
- Applicant
- NOVARTIS PHARMS
- Approval date
- 17 Jun 2009
- Application number
- BLA125319
- Status
- Authorised
- Status date
- 23 Oct 2009
- Authorisation date
- 23 Oct 2009
- Approved indications
- Periodic fever syndromes Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older: Cryopyrin-associated periodic syndromes Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including: Muckle-Wells syndrome (MWS), Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA), Severe forms of familial cold autoinflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash. Tumour necrosis factor receptor associated periodic syndrome (TRAPS) Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS). Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD). Familial Mediterranean fever (FMF) Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF). Ilaris should be given in combination with colchicine, if appropriate. Ilaris is also indicated for the treatment of: Still’s disease Ilaris is indicated for the treatment of active Still’s disease including adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate. Gouty arthritis Ilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.
- Product number
- EMEA/H/C/001109
- Authorisation holder
- Novartis Europharm Limited
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Arthritis, Gouty
- Arthritis, Juvenile Rheumatoid
- Cryopyrin-Associated Periodic Syndromes
European medicines record
- Patents
- 0
- Designations
- 5
- Earliest recorded loss of exclusivity
- 16 Jun 2027
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- canakinumab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- IL-1β
- Gene symbol
- IL-1β
- Median affinity
- 10.46
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Interleukin-1 beta inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-1 beta
- Protein identifier
- P01584
Open Targets mechanisms
- Mechanism
- Interleukin-1 beta inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-1 beta
- Condition
- Sarcoidosis, Pulmonary
- Highest recorded phase
- 2
- Condition identifier
- DOID:13406
- Subject identifier
- D017565
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Atrial Fibrillation
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000275
- Subject identifier
- D001281
- Condition
- Pulmonary Disease, Chronic Obstructive
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000341
- Subject identifier
- D029424
- Condition
- Immune System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Melanoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- Lung Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001071
- Subject identifier
- D008175
- Condition
- Macular Degeneration
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001365
- Subject identifier
- D008268
- Condition
- Arthritis, Juvenile
- Highest recorded phase
- 4
- Condition identifier
- EFO:0002609
- Subject identifier
- D001171
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Pneumonia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003106
- Subject identifier
- D011014
- Condition
- Behcet Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003780
- Subject identifier
- D001528
- Condition
- Atherosclerosis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003914
- Subject identifier
- D050197
- Condition
- Aortic Aneurysm, Abdominal
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004214
- Subject identifier
- D017544
- Condition
- Mucocutaneous Lymph Node Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004246
- Subject identifier
- D009080
- Condition
- Peripheral Arterial Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004265
- Subject identifier
- D058729
- Condition
- Gout
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004274
- Subject identifier
- D006073
- Condition
- Arthritis, Gouty
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004274
- Subject identifier
- D015210
- Condition
- Osteoarthritis, Knee
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004616
- Subject identifier
- D020370
- Condition
- Still's Disease, Adult-Onset
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007135
- Subject identifier
- D016706
- Condition
- Polymyalgia Rheumatica
- Highest recorded phase
- 2
- Condition identifier
- EFO:0008518
- Subject identifier
- D011111
- Condition
- Dry Eye Syndromes
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000906
- Subject identifier
- D015352
And 20 more, listed on the interactive page.
- Condition identifier
- DOID_13406
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000275
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000341
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000685
- Condition identifier
- EFO_0001071
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001365
- Highest recorded phase
- 1
- Condition identifier
- EFO_0002609
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003106
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003780
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003914
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004214
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004246
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004265
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004274
- Condition identifier
- EFO_0004616
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005531
- Highest recorded phase
- 2
- Condition identifier
- EFO_0006803
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007135
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009322
- Highest recorded phase
- 1
- Condition identifier
- EFO_1000906
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001165
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001345
- Highest recorded phase
- 2
And 76 more, listed on the interactive page.
- Event
- apparent death
- Reports
- 195
- Reporting signal score
- 982.242
- Event
- arthralgia
- Reports
- 138
- Reporting signal score
- 39.2022
- Event
- autoinflammatory disease
- Reports
- 10
- Reporting signal score
- 47.9497
- Event
- c-reactive protein abnormal
- Reports
- 48
- Reporting signal score
- 133.574
- Event
- c-reactive protein increased
- Reports
- 124
- Reporting signal score
- 223.24
- Event
- cellulitis
- Reports
- 57
- Reporting signal score
- 47.4175
- Event
- chronic infantile neurological cutaneous and articular syndrome
- Reports
- 7
- Reporting signal score
- 41.9231
- Event
- clubbing
- Reports
- 12
- Reporting signal score
- 46.5269
- Event
- condition aggravated
- Reports
- 150
- Reporting signal score
- 71.6444
- Event
- cryopyrin associated periodic syndrome
- Reports
- 29
- Reporting signal score
- 169.965
- Event
- deep vein thrombosis
- Reports
- 199
- Reporting signal score
- 322.709
- Event
- diverticulitis
- Reports
- 204
- Reporting signal score
- 554.405
- Event
- familial mediterranean fever
- Reports
- 21
- Reporting signal score
- 112.592
- Event
- haemophagocytic lymphohistiocytosis
- Reports
- 50
- Reporting signal score
- 147.234
- Event
- herpes zoster
- Reports
- 54
- Reporting signal score
- 39.6524
- Event
- histiocytosis haematophagic
- Reports
- 76
- Reporting signal score
- 266.247
- Event
- interstitial lung disease
- Reports
- 78
- Reporting signal score
- 87.213
- Event
- intestinal sepsis
- Reports
- 16
- Reporting signal score
- 85.852
- Event
- joint swelling
- Reports
- 228
- Reporting signal score
- 369.335
- Event
- juvenile idiopathic arthritis
- Reports
- 63
- Reporting signal score
- 240.427
- Event
- muckle-wells syndrome
- Reports
- 16
- Reporting signal score
- 97.9831
- Event
- pain
- Reports
- 330
- Reporting signal score
- 249.517
- Event
- photosensitivity reaction
- Reports
- 36
- Reporting signal score
- 52.7394
- Event
- pneumonia
- Reports
- 168
- Reporting signal score
- 87.2526
- Event
- pulmonary embolism
- Reports
- 201
- Reporting signal score
- 295.482
And 10 more, listed on the interactive page.
- NCT00424346
- NCT00487825
- NCT00504595
- NCT00505089
- NCT00554606
- NCT00619905
- NCT00426218
- NCT00503022
- NCT00581945
- NCT00605475
- NCT00900146
- NCT00663169
- NCT00798369
- NCT00819585
- NCT00927810
- NCT01029652
- NCT01080131
- NCT01356602
- NCT01362608
- NCT01431638
- NCT01470989
- NCT01593527
- NCT00770601
- NCT00947427
- NCT01322321
And 44 more, listed on the interactive page.
- Dose
- 150 mg
- Route
- Subcutaneous
- How often
- Every 8 weeks
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Sequence
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- QVQLVESGGGVVQPGRSLRLSCAASGFTFSVYGMNWVRQAPGKGLEWVAIIWYDGDNQYYADSVKGRFTISRDNSKNTLYLQMNGLRAEDTAVYYCARDLRTGPFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Sequence
- Type
- Protein
- Sequence
- QVQLVESGGGVVQPGRSLRLSCAASGFTFSVYGMNWVRQAPGKGLEWVAIIWYDGDNQYYADSVKGRFTISRDNSKNTLYLQMNGLRAEDTAVYYCARDLRTGPFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLEIVLTQSPDFQSVTPKEKVTITCRASQSIGSSLHWYQQKPDQSPKLLIKYASQSFSGVPSRFSGSGSGTDFTLTINSLEAEDAAAYYCHQSSSLPFTFGPGTKVDIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 0078-0734
Related records
Trials (279)
- "Debridement PhagE AnTibiotics for PJI"
- 1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement
- 8-Week Atopic Dermatitis (AD) Treatment Study
- A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
- A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines
- A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine
- A First-in-Human SAD and MAD Study in Healthy Participants to Evaluate Oral YR011 Tablet
- A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults
- A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer
- A Phase 1B Study of Canakinumab, Spartalizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer (PC) Patients
- A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclitaxel and Gemcitabine in the Neo-adjuvant Treatment of Patients With Pancreatic Cancer
- A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia
- A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine
- A Pilot Study on the Effects of ILARIS® on Patients With Proliferative Diabetic Retinopathy (PDRP)
- A Preliminary Exploratory Clinical Trial to Evaluate the Efficacy of NPDR-01 Eye Drops in the Treatment of Non-Proliferative Diabetic Retinopathy
- A Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer
- A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs).
- A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
- A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (OA)
- A Safety Study of 3 Different Bowel Cleansing Preparations
Approved for (8)
- CINCA syndrome
- Cryopyrin-associated periodic syndrome
- Familial Mediterranean fever
- Gout
- Immune system disorder
- Juvenile idiopathic arthritis
- Mevalonate kinase deficiency
- Muckle-Wells syndrome
In development for (39)
- Abdominal aortic aneurysm Phase 2
- Adult-onset Still disease Phase 3
- Age-related macular degeneration Phase 1
- Alcoholic hepatitis Phase 2
- Atherosclerosis Phase 3
- Atrial fibrillation Phase 2
- Behcet disease Phase 2
- Breast cancer Phase 1
- Chronic idiopathic urticaria Phase 2
- Chronic obstructive pulmonary disease Phase 1
- COVID-19 Phase 3
- Dry eye syndrome Phase 2
- Exocrine pancreatic carcinoma Phase 3
- Hypoglycemia Phase 3
- Kawasaki disease Phase 2
- Lung cancer Phase 3
- Lung carcinoma Phase 3
- Melanoma Phase 2
- Myelodysplastic syndrome Phase 1
- Non-small cell lung carcinoma Phase 3
Other linked conditions (1)
- Duchenne muscular dystrophy
Targets (1)
- IL1B Interleukin-1 beta inhibitor