Data updated: May 26, 2026
ILARIS (canakinumab)
Genetically Validated
Trial Activity: Declining 10 active trials
Immunology
Approved 2009-06-17
ILARIS is indicated for the treatment of 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; Still's Disease; Gout.
Source: FDA Label • Novartis
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.
Development Insights
Novartis Pharmaceuticals conducting 31 trials (52%)
73 indications explored (Broad Platform)
→ systemic juvenile idiopathic arthritis (7 trials)
→ non-small cell lung cancer (5 trials)
→ acute gout (5 trials)
6
Indications
--
Phase 3 Trials
4
Priority Reviews
16
Years on Market
Details
- Status
- Prescription
- First Approved
- 2009-06-17
- Patent Cliff
- 2027
- Revenue
- $514M (Q4-2025)
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
ILARIS Approval History
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
15 FDA actions from 2009 to 2024 · 5 indication expansions
Nov 2011 SUPPL
Label
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
Source: FDA Label
ILARIS Target & Pathway
ProTarget
ILARIS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
1
Same target(s) AND same indication — head-to-head.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 8 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ILARIS
3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
📋
Clinical Trial Registry
52 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05467800 | GCO 22-0543 MPN-RC 122 | Ph 2 | active not recruiting | Study of Canakinumab in Patients With Myelofibrosis |
| NCT04789681 | 2020-0674 NCI-2020-11724, 2020-0674 | Ph 2 | recruiting | Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial |
| NCT04239157 | 2019-0339 NCI-2019-08494, 2019-0339 | Ph 2 | recruiting | 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 |
| NCT04717635 results posted | CACZ885G1302 2021-003706-50 | Ph 3 | completed | Study of Efficacy and Safety of Canakinumab in Japanese Patients With AOSD |
| NCT05984602 | 22-01205 | Ph 1 | active not recruiting | 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 |
| NCT03631199 CANOPY-1 results posted | CACZ885U2301 2024-511490-29-00 | Ph 3 | terminated | Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects |
| NCT06038526 | OSU-22297 NCI-2023-05942 | Ph 2 | active not recruiting | Evaluation of Canakinumab in High-Risk Former-Smokers |
| NCT05641831 | OSU-22091 NCI-2022-09409 | Ph 2 | recruiting | Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study |
| NCT05535738 | STUDY00000321 | Ph 2, Ph 3 | active not recruiting | Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation |
| NCT04814368 results posted | CLNA043A12203 | Ph 2 | terminated | 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) |
| NCT04795466 results posted | CADPT06A12201 | Ph 2 | terminated | Study of the Efficacy and Safety of Various Anti-inflammatory Agents in Participants With Mild Cognitive Impairment or Mild Alzheimer's Disease |
| NCT04810611 | CMBG453E12101 2019-004623-21 | Ph 1 | terminated | Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT04905316 CHORUS | 21-004 | Ph 2 | active not recruiting | A Study of Canakinumab With Chemotherapy, Radiation Therapy, and Durvalumab in People With Lung Cancer |
| NCT03742349 | CADPT01A12101C 2018-002244-82 | Ph 1 | terminated | Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). |
| NCT05401578 CanpHy | 2021-02325; kt21Donath2 | Ph 3 | recruiting | Canakinumab for the Treatment of Postprandial Hypoglycemia |
| NCT03447769 Canopy-A results posted | CACZ885T2301 2017-004011-39 | Ph 3 | terminated | Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A |
| NCT03968419 CANOPY-N results posted | CACZ885V2201C 2018-004813-42 | Ph 2 | terminated | This Study Will Evaluate the Effect of Canakinumab or Pembrolizumab Given as Monotherapy or in Combination as Neo-adjuvant Treatment for Subjects With Early Stages NSCLC. |
| NCT03626545 CANOPY-2 results posted | CACZ885V2301 2018-002480-26 | Ph 3 | terminated | Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy |
| NCT02272946 results posted | Canakinumab | Ph 2 | completed | Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk |
| NCT05725343 CANAL | IRFMN-LUNG-8287 | Ph 3 | terminated | A Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer |
| NCT03064854 | CPDR001C2101 2016-002815-17 | Ph 1 | terminated | PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients |
| NCT04362813 CAN-COVID results posted | CACZ885D2310 2020-001370-30 | Ph 3 | completed | Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia |
| NCT04510493 CanCovDia | 2020-02008; me20Donath2 | Ph 3 | completed | Canakinumab in Patients With COVID-19 and Type 2 Diabetes |
| NCT00927810 results posted | CACZ885H2251E1 | Ph 2 | completed | Long Term Study of Canakinumab (ACZ885) in Patients With Gout |
| NCT00770601 results posted | CACZ885D2201 09-AR-0006 | Ph 3 | terminated | Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease |
| NCT00991146 | CACZ885D2308 | Ph 3 | completed | Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase |
| NCT02204293 CONSIDER results posted | CACZ885GDE01T 2011-001027-20 | Ph 2 | terminated | Canakinumab for Treatment of Adult-onset Still's Disease |
| NCT02756650 Behcet results posted | CACZ885NTR01 | Ph 2 | completed | 1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement |
| NCT02334748 results posted | CACZ885GFR01 2014-002872-95 | Ph 3 | completed | A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies |
| NCT01327846 CANTOS results posted | CACZ885M2301 2010-022970-14 | Ph 3 | completed | Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events) |
| NCT02396212 results posted | CACZ885G1301 2018-002355-15 | Ph 3 | completed | Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA |
| NCT01245127 | S52762 | Ph 2 | completed | Ilaris (Canakinumab) in the Schnitzler Syndrome |
| NCT00891046 β-SPECIFIC 3 results posted | CACZ885G2301E1 EudraCT: 2008-008008-42 | Ph 3 | completed | An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever. |
| NCT00819585 results posted | CACZ885H2251 EudraCT : 2008-005876-28 | Ph 2 | completed | A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study) |
| NCT01390350 ILESCH | CACZ885DDE03T 2010-024156-28 | Ph 2 | completed | Ilaris® Effects in Schnitzler Syndrome (ILESCH) |
| NCT02059291 results posted | CACZ885N2301 | Ph 3 | completed | Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers |
| NCT00886769 β-SPECIFIC 1 results posted | CACZ885G2305 EudraCT: 2008-005476-27 | Ph 3 | terminated | Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA) |
| NCT02980263 | CACZ885D2208 | Ph 2 | withdrawn | Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease |
| NCT01805960 CONVERT-AF | CONVERT-AF Version5 22.01.2013 | Ph 2 | terminated | Canakinumab for the Prevention of Recurrences After Electrical Cardioversion: CONVERT-AF |
| NCT01148797 CONTROL FMF | CACZ885D2204 | Ph 2 | completed | Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF) |
| NCT01302795 | DER-USZ-AAN-008 | Ph 2 | completed | Canakinumab for Pyoderma Gangrenosum |
| NCT01303380 results posted | CACZ885D2402 2010-020904-31 | Ph 2 | completed | Canakinumab in Patients With Active Hyper-IgD Syndrome |
| NCT01676948 β-SPECIFIC 4Pa | CACZ885G2402 2012-003054-92 | Ph 3 | withdrawn | An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA) |
| NCT00663169 results posted | CACZ885A2212 | Ph 2 | completed | Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout |
| NCT01160822 results posted | CACZ885C2201 2009-015017-48 | Ph 2 | completed | To Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee |
| NCT00889863 β-SPECIFIC 2 results posted | CACZ885G2301 EudraCT: 2008-005479-82 | Ph 3 | completed | Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA) |
| NCT01170936 ILUVIT | ILUVIT1 2010-020063-21 | Ph 2 | completed | Ilaris® in Urticarial Vasculitis - Investigation of Treatment Responses |
| NCT01276522 | 2010-SS-Canakinumab | Ph 2 | completed | Efficacy and Safety of Canakinumab in Schnitzler Syndrome |
| NCT01088880 | CACZ885DTR01 | Ph 2 | completed | Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever |
Showing 50 of 52 trials
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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
Indications & Usage
FDA Label (PDF)ILARIS is indicated for the treatment of 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; Still's Disease; Gout.
Pro Intelligence Preview
Deep insights for ILARIS
Revenue Insights
- • Q4-2025: $514M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • Generic/biosimilar risk
Trial Analysis
- • 60 total trials
- • Stage: Declining
Competitive Landscape
- • 14 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment