ILARIS
Ilaris (canakinumab) is an interleukin-1β blocker indicated for the treatment of several autoinflammatory conditions, including various Periodic Fever Syndromes and Still’s disease. It is approved for use in both adult and pediatric populations, with specific age requirements such as four years and older for Cryopyrin-Associated Periodic Syndromes and two years and older for Still’s disease. The medication is also indicated for managing gout flares in adults when conventional therapies, such as NSAIDs and colchicine, are contraindicated, not tolerated, or provide an inadequate response.
How ILARIS Works
Canakinumab is a human monoclonal antibody that targets and binds to human interleukin-1β (IL-1β). By binding to this specific cytokine, the drug neutralizes its activity and prevents it from interacting with IL-1 receptors. This blockade inhibits the inflammatory response driven by the overproduction of IL-1β, which is a central feature of Periodic Fever Syndromes, Still’s disease, and gout flares.
Details
- Status
- Prescription
- First Approved
- 2009-06-17
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
ILARIS Approval History
What ILARIS Treats
10 indicationsILARIS is approved for 10 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Periodic Fever Syndromes
- Cryopyrin-Associated Periodic Syndromes
- Familial Cold Autoinflammatory Syndrome
- Muckle-Wells Syndrome
- Tumor Necrosis Factor Receptor Associated Periodic Syndrome
- Hyperimmunoglobulin D Syndrome
- Mevalonate Kinase Deficiency
- Familial Mediterranean Fever
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ILARIS FDA Label Details
ProIndications & Usage
FDA Label (PDF)ILARIS is an interleukin-1β blocker indicated for the treatment of: • Periodic Fever Syndromes : - Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older, including: ◾ Familial Cold Auto-inflammatory Syndrome (FCAS) ◾ Muckle-Wells Syndrome (MWS) - Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients - Hyperimmunoglobulin D Syndrome (HIDS)/ Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients - Familial Mediterranean Fever (FMF) in adult and pediatric patients • Active Still’s Disease, includin...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.