Ilaris(canakinumab)
Ilaris (canakinumab) is an antibody pharmaceutical. Canakinumab was first approved as Ilaris on 2009-06-17. It is used to treat cryopyrin-associated periodic syndromes, familial mediterranean fever, juvenile arthritis, and mevalonate kinase deficiency in the USA. It has been approved in Europe to treat arthritis, cryopyrin-associated periodic syndromes, and gouty arthritis. The pharmaceutical is active against interleukin-1 beta.
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Commercial
Therapeutic Areas
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FDA
EMA
Ilaris
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Canakinumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Ilaris | canakinumab | Novartis Pharmaceuticals Corporation | N-125319 RX | 2016-12-22 | 1 products |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ilaris | Biologic Licensing Application | 2023-08-25 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
canakinumab, Ilaris, Novartis Pharmaceuticals Corporation | |||
| 2027-06-16 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0638 | Injection, canakinumab, 1 mg |
Clinical
Clinical Trials
109 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 2 | 6 | — | 1 | — | 7 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | — | — | 1 | — | 1 |
| Spondylarthritis | D025241 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gouty arthritis | D015210 | — | — | — | 2 | 5 | — | 1 | 8 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | 1 | 1 | 7 | — | — | 8 |
| Cryopyrin-associated periodic syndromes | D056587 | — | M04.2 | — | — | 7 | — | 1 | 8 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 2 | 3 | — | — | 6 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 4 | 2 | — | — | 5 |
| Adult-onset still's disease | D016706 | EFO_0007135 | M06.1 | — | 1 | 1 | — | — | 2 |
| Cytokine release syndrome | D000080424 | — | D89.83 | — | — | 1 | — | 1 | 2 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | 1 | — | — | 2 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 1 | 1 | — | — | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | 1 | — | — | 1 |
Show 3 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | — | D46 | 2 | 3 | — | — | — | 4 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | — | — | 2 | 3 |
| Schnitzler syndrome | D019873 | EFO_1001165 | — | — | 3 | — | — | — | 3 |
| Mucocutaneous lymph node syndrome | D009080 | EFO_0004246 | M30.3 | — | 1 | — | — | 1 | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 2 | — | — | — | 2 |
| Melanoma | D008545 | — | — | — | 1 | — | — | — | 1 |
| Familial mediterranean fever | D010505 | — | M04.1 | — | 1 | — | — | — | 1 |
| Gout | D006073 | EFO_0004274 | M10 | — | 1 | — | — | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | 1 | — | — | — | 1 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 1 | — | — | — | 1 |
Show 29 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Triple negative breast neoplasms | D064726 | — | — | 2 | — | — | — | — | 2 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | — | — | — | — | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Fever | D005334 | HP_0001945 | R50.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 2 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | — | — | 1 | 1 |
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | — | 1 | 1 |
| Pulmonary arterial hypertension | D000081029 | — | — | — | — | — | — | 1 | 1 |
Show 14 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Canakinumab |
| INN | canakinumab |
| Description | Immunoglobulin G1, anti-[Homo sapiens interleukin 1, beta (IL1B)] human monoclonal ACZ885; gamma1 heavy chain (Homo sapiens VH-IGHG1*03) (221-214’)-disulfide with kappa light chain (Homo sapiens V-KAPPA-IGKC*01); (227-227’’:230-230’’)-bisdisulfide dimer |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >4G5Z:H|canakinumab antibody fragment heavy chain
QVQLVESGGGVVQPGRSLRLSCAASGFTFSVYGMNWVRQAPAKGLEWVAIIWYDGDNQYYADSVKGRFTISRDNSKNTLY
LQMNGLRAEDTAVYYCARDLRTGPFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWN
SGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVAP
>4G5Z:L|canakinumab antibody fragment light chain
EIVLTQSPDFQSVTPKEKVTITCRASQSIGSSLHWYQQKPDQSPKLLIKYASQSFSGVPSRFSGSGSGTDFTLTINSLEA
EDAAAYYCHQSSSLPFTFGPGTKVDIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ
ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRG |
Identifiers
| PDB | 4G5Z, 4G6J, 5BVJ, 5BVP |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201834 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06168 |
| UNII ID | 37CQ2C7X93 (ChemIDplus, GSRS) |
Target
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Variants
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Ilaris – Novartis
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Trends
PubMed Central
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Safety
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Adverse Events
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8,419 adverse events reported
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