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Drug

Canakinumab

Approved · EMA
ClassInterleukin-1 beta inhibitorEmerging researchLate-stage development

Also known as Ilaris, Canakinumab (human)(recombinant)(murine).

2
Research papers
10
Active clinical trials
Interleukin-1 beta
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Clinical trial2026-07-09Results expected Q1 2028 · ClinicalTrials.gov

Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis

Clinical trial2026-06-18Results expected Q1 2029 · ClinicalTrials.gov

Single Arm Phase II Trial Using Canakinumab for the Prevention of Lung Cancer (Can-Prevent-Lung)

Clinical trial2026-06-12Results expected Q4 2027 · ClinicalTrials.gov

Canakinumab for the Treatment of Postprandial Hypoglycemia - CanpHy Study

Clinical trial2026-05-31Primary completion · ClinicalTrials.gov

Molecular Studies of Canakinumab in High-Risk Former-Smokers (CANIFS)

Clinical trial2026-05-26Completed · ClinicalTrials.gov

Approval: Ilaris (EMA)

Regulatory2009-10-23EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Canakinumab
Aliases & brands
IlarisCanakinumab (human)(recombinant)(murine)
RxNorm CUI
853491
ChEMBL ID
CHEMBL1201834
ATC codes
L04AC08
UNII
37CQ2C7X93
Primary mechanism
Interleukin-1 beta inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Interleukin-1 beta
IL1B · P01584
INHIBITORInterleukin-1 beta inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2009-10-23
Latest approval
2009-10-23
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2009-10-23Approval
Approval: Ilaris (EMA)
Indication: Periodic fever syndromes Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years andShow full indication

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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

76 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
76
registered trials across all phases
LATEST COMPLETION 2026
10
Active studies
6
Recruiting
26
Late-stage (III+)
43
Completed
23
Discontinued
PHASE DISTRIBUTIONn = 76
Early Phase 11Phase 16Phase 1 / 23Phase 240Phase 2 / 32Phase 323Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20112021
Major research themes1
Interleukin-6 Inhibitors1
Journals, researchers & institutions
Top journals
  • Annals of the rheumatic diseases1
  • Circulation research1
Leading researchers
  • Arulmani U1
  • Balfour A1
  • De Meulemeester M1
  • Krammer G1
  • Lin HY1
  • Mysler E1
  • Rane M1
  • Ridker PM1
Leading institutions
free-text, unnormalised
  • Center for Cardiovascular Disease Prevention1
  • University of Medicine and Dentistry of New Jersey1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 8 of the same disease areas as Canakinumab in the shared literature.

8 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.