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
Trade Name
FDA
EMA
Ilaris (discontinued: 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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ilaris | Biologic Licensing Application | 2025-06-18 |
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
115 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 3 | 9 | 11 | 1 | 2 | 23 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 2 | 6 | — | 1 | — | 7 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | — | — | 1 | — | 1 |
| Spondylarthritis | D025241 | — | — | — | — | — | 1 | — | 1 |
| Spondylitis | D013166 | — | M46.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | 5 | 9 | — | 3 | 17 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | 1 | 1 | 7 | — | 1 | 9 |
| Cryopyrin-associated periodic syndromes | D056587 | — | M04.2 | — | — | 7 | — | 2 | 9 |
| Gouty arthritis | D015210 | — | — | — | 2 | 5 | — | 1 | 8 |
| Fever | D005334 | — | R50.9 | — | 3 | 3 | — | 1 | 7 |
| Familial mediterranean fever | D010505 | — | M04.1 | — | 2 | 3 | — | 1 | 6 |
| Hereditary autoinflammatory diseases | D056660 | — | — | — | 3 | 2 | — | 1 | 6 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 2 | 3 | — | — | 6 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 4 | 2 | — | — | 5 |
| Eosinophilia | D004802 | — | D72.1 | — | — | 5 | — | — | 5 |
Show 18 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 |
| Brucellosis | D002006 | EFO_0007185 | A23 | — | 2 | — | — | 1 | 3 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 2 | — | — | — | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | — | — | 1 | 2 |
| Preleukemia | D011289 | — | — | — | 2 | — | — | — | 2 |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | 2 | — | — | — | 2 |
| Schnitzler syndrome | D019873 | EFO_1001165 | — | — | 2 | — | — | — | 2 |
| Mevalonate kinase deficiency | D054078 | — | M04.1 | — | 1 | — | — | 1 | 2 |
| Melanoma | D008545 | — | — | — | 1 | — | — | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | 1 | — | — | — | 1 |
Show 38 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | — | — | — | — | 2 |
| Triple negative breast neoplasms | D064726 | — | — | 2 | — | — | — | — | 2 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | — | — | — | — | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
| Colorectal neoplasms | D015179 | — | — | 1 | — | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | 1 | — | — | — | — | 1 |
| Retinal diseases | D012164 | — | H35.9 | 1 | — | — | — | — | 1 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | 1 | — | — | — | — | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 1 | 1 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | — | — | 1 | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | — | — | — | 1 | 1 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | — | — | — | 1 | 1 |
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
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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11,694 adverse events reported
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