Drugs / Canakinumab
last change Jul 2026 re-read 2 minutes ago

Canakinumab

also known as ACZ885 · Ilaris · ACZ885D · AIN457

Monoclonal antibody targets IL1B via inhibition

Developed for
gout · non-small cell lung carcinoma · systemic-onset juvenile idiopathic arthritis · Muckle-Wells syndrome · rheumatoid arthritis · CINCA syndrome · familial cold autoinflammatory syndrome · myelodysplastic syndrome
+60 more · type 2 diabetes mellitus · Schnitzler syndrome · adult-onset Still disease · atherosclerosis · cytokine release syndrome · familial Mediterranean fever · hereditary periodic fever syndrome · lung carcinoma · triple-negative breast carcinoma · type 1 diabetes mellitus · vasculitis · abdominal aortic aneurysm · allergic contact dermatitis · Alzheimer disease · anemia · atherosclerotic cardiovascular disease · atrial fibrillation · autoinflammatory syndrome · Behcet disease · cardiovascular disorder · chronic idiopathic urticaria · chronic myelomonocytic leukemia · chronic obstructive pulmonary disease · clear cell renal carcinoma · clonal hematopoiesis of indeterminate potential · cognitive impairment with or without cerebellar ataxia · colorectal cancer · cryopyrin-associated periodic syndrome · dry eye syndrome · Duchenne muscular dystrophy · glucose intolerance · HIV infectious disease · inflammatory disease · juvenile idiopathic arthritis · Kawasaki disease · lung cancer · malignant pancreatic neoplasm · melanoma · mevalonate kinase deficiency · myelofibrosis · osteoarthritis · osteoarthritis, knee · pancreatic adenocarcinoma · pancreatic ductal adenocarcinoma · periodic fever syndrome · peripheral arterial disease · PFAPA syndrome · polymyalgia rheumatica · prediabetes syndrome · primary myelofibrosis · proliferative diabetic retinopathy · pulmonary sarcoidosis · pyoderma gangrenosum · sickle cell disease · TNF receptor 1-associated periodic fever syndrome · urticaria · wet macular degeneration · alcoholic hepatitis · COVID-19 · hypoglycemia
Investigated by
Novartis Pharmaceuticals · Novartis · Charite University, Berlin, Germany · M.D. Anderson Cancer Center · Massachusetts General Hospital · NYU Langone Health
+39 more · Pancreatic Cancer Action Network · Pediatric Rheumatology International Trials Organization · University of Zurich · AbbVie · Bristol-Myers Squibb · Broad Institute of MIT and Harvard · Children's National Research Institute · Columbia University · Eli Lilly and Company · Foundation to Eradicate Duchenne · H. Lee Moffitt Cancer Center and Research Institute · Illumination Health · International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Jeffrey Curtis · John Mascarenhas · Mario Negri Institute for Pharmacological Research · Memorial Sloan Kettering Cancer Center · National Cancer Institute (NCI) · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institutes of Health (NIH) · PD Dr. med. Stephan Michels · PRINTO / PRCSG · Peter Shields · Pfizer · Priscilla Hsue, MD · Rabin Medical Center · Radboud University Medical Center · Southwest Pediatric Nephrology Study Group · Uma Borate · Universitaire Ziekenhuizen KU Leuven · University Hospital, Basel, Switzerland · University Hospital, Zürich · University of Alabama at Birmingham · University of Leipzig · University of Nebraska · University of Pennsylvania · Wei-Che Ko · Yale University

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (5) US (FDA) ILARIS 2013-05-09 – 2023-08-25 fda.gov
Approved EU (EMA) Ilaris 2009-10-23 europa.eu
Approved US (FDA) ILARIS 2009-06-17 fda.gov

Trials 100 · started per year

today
US approved 2009
EU approved 2009
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT04028245 Aug 2019 → Mar 2025 clear cell renal carcinoma Columbia University Completed No outcome recorded
Phase 110 trials
Phase 1 NCT05984602 Jul 2023 → Sep 2025 overdue malignant pancreatic neoplasm NYU Langone Health Active not recruiting No outcome recorded
Phase 1 NCT04810611 Jun 2021 → Apr 2024 myelodysplastic syndrome Novartis Pharmaceuticals Terminated No outcome recorded
Phase 1 NCT04581343 Nov 2020 → Nov 2022 pancreatic ductal adenocarcinoma Pancreatic Cancer Action Network Completed No outcome recorded
Phase 1 NCT03742349 Jan 2019 → Feb 2023 triple-negative breast carcinoma Novartis Pharmaceuticals Terminated No outcome recorded
Phase 1 NCT03064854 May 2017 → Jul 2021 non-small cell lung carcinoma Novartis Pharmaceuticals Terminated No outcome recorded
Phase 1 NCT02900664 Aug 2016 → Mar 2021 colorectal cancer, non-small cell lung carcinoma, triple-negative breast carcinoma Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02775994 Aug 2016 → Jan 2020 PFAPA syndrome Rabin Medical Center Unknown No outcome recorded
Phase 1 NCT01589029 Apr 2012 → Nov 2014 proliferative diabetic retinopathy PD Dr. med. Stephan Michels Terminated No outcome recorded
Phase 1 NCT00421226 Dec 2006 → Oct 2007 Novartis Completed No outcome recorded
Phase 1 NCT00503022 Jul 2006 → ? wet macular degeneration Novartis Completed No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT04798339 Mar 2021 → May 2025 overdue myelodysplastic syndrome H. Lee Moffitt Cancer Center and Research Institute Active not recruiting No outcome recorded
Phase 1/2 NCT03936894 May 2019 → Apr 2024 Duchenne muscular dystrophy Children's National Research Institute Unknown No outcome recorded
Phase 1/2 NCT00505089 Aug 2007 → May 2009 rheumatoid arthritis Novartis Terminated No outcome recorded
Phase 1/2 NCT00581945 Jan 2007 → May 2010 chronic obstructive pulmonary disease Novartis Completed No outcome recorded
Phase 1/2 NCT00426218 Dec 2006 → Mar 2010 juvenile idiopathic arthritis Novartis Completed No outcome recorded
Phase 249 trials
Phase 2 NCT06691217 Mar 2026 → Jan 2029 expected atherosclerotic cardiovascular disease, vasculitis Massachusetts General Hospital Recruiting No outcome recorded
Phase 2 NCT07138898 Dec 2025 → Jan 2028 expected rheumatic disorder NYU Langone Health Recruiting No outcome recorded
Phase 2 NCT06038526 Mar 2024 → Feb 2026 lung carcinoma Peter Shields Completed No outcome recorded
Phase 2 NCT05641831 Feb 2023 → Dec 2028 expected clonal hematopoiesis of indeterminate potential Uma Borate Recruiting No outcome recorded
Phase 2 NCT05467800 Aug 2022 → Oct 2026 expected myelofibrosis, primary myelofibrosis John Mascarenhas Active not recruiting No outcome recorded
Phase 2 NCT05237713 Apr 2022 → Feb 2024 anemia, myelodysplastic syndrome University of Leipzig Terminated No outcome recorded
Phase 2 NCT04795466 Oct 2021 → Mar 2024 Alzheimer disease, cognitive impairment with or without cerebellar ataxia Novartis Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT04814368 Aug 2021 → Jun 2024 osteoarthritis, knee Novartis Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT04789681 Jul 2021 → Dec 2027 expected lung carcinoma M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT04905316 May 2021 → Jul 2026 non-small cell lung carcinoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT05535738 Nov 2022 → Jan 2027 expected allergic contact dermatitis Wei-Che Ko Active not recruiting No outcome recorded
Phase 2/3 NCT00900146 Apr 2009 → Nov 2010 type 2 diabetes mellitus Novartis Terminated No outcome recorded
Phase 331 trials
Phase 3 NCT05725343 Feb → Apr 2022 lung cancer Mario Negri Institute for Pharmacological Research Terminated No outcome recorded
Phase 3 NCT04717635 Mar 2021 → Apr 2025 adult-onset Still disease Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT04362813 Apr → Sep 2020 cytokine release syndrome Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT04229004 Jan 2020 → Feb 2025 pancreatic adenocarcinoma Pancreatic Cancer Action Network Completed No outcome recorded
Phase 3 NCT03626545 Jan 2019 → Jan 2021 non-small cell lung carcinoma Novartis Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT03631199 Dec 2018 → Aug 2021 non-small cell lung carcinoma Novartis Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT03447769 Mar 2018 → Mar 2022 non-small cell lung carcinoma Novartis Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT02911857 Oct 2016 → Jan 2017 periodic fever syndrome Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT02396212 May 2015 → Mar 2017 systemic-onset juvenile idiopathic arthritis Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT02296424 Nov 2014 → Oct 2016 systemic-onset juvenile idiopathic arthritis Novartis Pharmaceuticals Completed No outcome recorded
Phase 41 trial
Phase 4 NCT05080218 Nov 2021 → Apr 2024 psoriatic arthritis, spondyloarthropathy Jeffrey Curtis Completed No outcome recorded
Phase not stated1 trial
NCT04476706 cytokine release syndrome Novartis Pharmaceuticals No longer available No outcome recorded
Also used as a comparator or background therapy in 7 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT06481189 Comparator Sep 2022 → Mar 2023 AO GENERIUM Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00619905 Comparator Dec 2003 → Aug 2005 rheumatoid arthritis Novartis Completed No outcome recorded
Phase 22 trials
Phase 2 NCT04365153 Comparator Apr 2020 → Feb 2021 COVID-19 The Cleveland Clinic Completed No outcome recorded
Phase 2 NCT03775109 Comparator Feb 2019 → Mar 2023 alcoholic hepatitis Imperial College London Completed No outcome recorded
Phase 33 trials
Phase 3 NCT06497491 Comparator Dec 2023 → May 2025 adult-onset Still disease AO GENERIUM Completed No outcome recorded
Phase 3 NCT05401578 Comparator Apr 2023 → May 2026 overdue hypoglycemia University Hospital, Basel, Switzerland Recruiting No outcome recorded
Phase 3 NCT04510493 Comparator Oct 2020 → Aug 2021 COVID-19, type 2 diabetes mellitus University Hospital, Basel, Switzerland Completed No outcome recorded

Press releases naming this drug 11 releases

DateIssuerRelease
2022-08-15 Novartis Pharmaceuticals Novartis provides update on Phase III CANOPY-A study evaluating canakinumab as adjuvant treatment in non-small cell lung cancer novartis.com
2021-10-25 Novartis Pharmaceuticals Novartis top-line results for CANOPY-1 Phase III study support further evaluation of canakinumab in lung cancer novartis.com
2021-03-09 Novartis Pharmaceuticals Novartis provides update on Phase III study evaluating canakinumab (ACZ885) as second or third-line treatment in combination with chemotherapy in non-small cell lung cancer novartis.com
2019-06-03 Novartis Pharmaceuticals Novartis Shows Growing Strength in Lung Cancer Innovation with New Capmatinib Investigational Data and Novel Canakinumab Clinical Trials novartis.com
2017-11-13 Novartis Pharmaceuticals Novartis canakinumab (ACZ885) reduced cardiovascular risk by 25% in subgroup of CANTOS Phase III trial participants novartis.com
2017-08-27 Novartis Pharmaceuticals Novartis Phase III CANTOS study demonstrates that targeting inflammation with ACZ885 reduces cardiovascular risk novartis.com
2017-08-27 Novartis Pharmaceuticals Novartis announces analysis published in The Lancet showing ACZ885 reduced lung cancer mortality by 77% in the CANTOS study with further studies planned novartis.com
2017-06-22 Novartis Pharmaceuticals Novartis Phase III study shows ACZ885 (canakinumab) reduces cardiovascular risk in people who survived a heart attack novartis.com
2016-12-16 Novartis Pharmaceuticals Novartis receives positive CHMP recommendation for Ilaris® to treat rare diseases in adults and children called Periodic Fever Syndromes novartis.com
2016-09-23 Novartis Pharmaceuticals Novartis receives three new FDA approvals for the expanded use of Ilaris treating rare Periodic Fever Syndrome conditions novartis.com
2016-04-27 Novartis Pharmaceuticals Novartis receives three FDA Breakthrough Therapy Designations for Ilaris to treat rare types of Periodic Fever Syndromes novartis.com

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 113 sources stand behind the page.

FieldValueCited text
Known as canakinumab Canakinumab, a fully human interleukin-1β monoclonal antibody, approved for the cryoporin-associated periodic syndrome, may offer a practical advantage because its half-life of...” PMID 22901459 Aug 2012
87

“An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)” NCT01676948

“Pharmacokinetics and pharmacodynamics of the anti-interleukin (IL)-1β monoclonal antibody, canakinumab, in gouty arthritis patients from three studies are reported.” PMID 24122883 Sep 2013

“Rapid and Sustained Long-Term Efficacy and Safety of Canakinumab in Patients With Cryopyrin-Associated Periodic Syndrome Ages Five Years and Younger.” PMID 31161734 Sep 2019

Canakinumab is a human anti-interleukin-1beta monoclonal antibody.” PMID 19494217 Jun 2009

Canakinumab 150 mg s.c.” NCT01593527

NCT04810611

NCT00554606

NCT00886769

NCT01160822

NCT01356602

NCT02911857

NCT05535738

NCT00891046

NCT02334748

NCT05237713

NCT03626545

NCT06038526

NCT04510493

NCT00927810

NCT00581945

NCT03936894

NCT00685373

NCT00487825

NCT00947427

NCT04229004

NCT00487708

NCT01731990

NCT04814368

NCT07138898

NCT01105507

NCT01589029

NCT01635127

NCT01080131

NCT05467800

NCT06691217

NCT03447769

NCT01068860

NCT01390350

NCT03064854

NCT04717635

NCT05984602

NCT03968419

NCT02775994

NCT02204293

NCT05725343

NCT02296424

NCT01148797

NCT03742349

NCT00889863

NCT01029652

NCT00770601

NCT00900146

NCT00605475

NCT00424346

NCT05401578

NCT04581343

NCT04028245

NCT01362608

NCT01276522

NCT01250171

NCT02980263

NCT05641831

NCT04239157

NCT04795466

NCT01170936

NCT01302795

NCT04476706

NCT04789681

NCT00663169

NCT02756650

NCT02396212

NCT01431638

NCT01303380

NCT00991146

NCT03631199

NCT04362813

NCT01088880

NCT01805960

NCT05080218

NCT00819585

NCT02059291

NCT04365153

NCT04905316

NCT04798339

NCT03775109

NCT01327846

NCT02272946

Known as ACZ885 “A Randomized, Controlled Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are...” NCT01080131
33

“Canakinumab (ACZ885) will be dosed at 200mg via subcutaneous injection every 3 weeks x 3 injections that will start with concurrent chemoradiation, followed by 200mg via...” NCT04905316

“This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal...” NCT00798369

“An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)” NCT01676948

“Canakinumab (ACZ885, a fully human IgG1 anti-IL-1β mAb) induces sustained remission in pediatric patients with cryopyrin-associated periodic syndrome (CAPS).” PMID 21356079 Feb 2011

“This study combines canakinumab (ACZ885), a high-affinity human anti-interleukin-1β (IL-1β) monoclonal antibody (mAb)” NCT04581343

“A 12 Weeks Randomized, Controlled Core Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares” NCT01029652

“Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks.” NCT01576367

“An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis” NCT00891046

“Participants received an initial dose of 1 mg/kg canakinumab (ACZ885) via intravenous infusion.” NCT00581945

“Patients will be treated on demand with canakinumab (ACZ885) in this extension study.” NCT00927810

“Canakinumab (ACZ885)” NCT01731990

“Canakinumab (ACZ885)” NCT01302860

“Canakinumab (ACZ885)” NCT02911857

“Canakinumab (ACZ885)” NCT00685373

“Canakinumab, ACZ885NCT01362608

NCT01470989

NCT02888080

NCT00504595

NCT01322321

NCT01364389

NCT00426218

NCT01242813

NCT03484923

NCT00503022

NCT02900664

NCT00619905

NCT00465985

NCT00505089

NCT00421226

NCT02961218

NCT02007252

NCT00995930

NCT01302860

Known as ACZ885D “canakinumab (company code: ACZ885D)” NCT01105507
Known as AIN457 “Canakinumab (AIN457)” NCT02911857
Known as Ilaris “This is a multi-center double-blind placebo-controlled study to assess the efficacy and safety of canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody that...” NCT01390350
8

“The pilot study evaluates the efficacy and safety of Canakinumab (ILARIS®) in subjects with proliferative diabetic retinopathy secondary to type 1 and 2 diabetes.” NCT01589029

“Canakinumab (Ilaris®, Novartis Switzerland) will be used in the recommended standard dose of 150 mg subcutaneously once.” NCT05401578

“Canakinumab (Ilaris, Novartis Pharma) is a fully human anti-interleukin-1-bèta monoclonal antibody.” NCT01245127

“Single Escalating Dose Pilot Trial of Canakinumab (ILARIS®) in Duchenne Muscular Dystrophy” NCT03936894

“single doses of canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody” NCT01170936

“CANAKINUMAB (ILARIS®)” NCT06691217

NCT06497491

NCT06481189

Action Inhibit “Canakinumab is a fully human anti-interleukin IL-1beta monoclonal antibody, being investigated for the treatment of rheumatoid arthritis (RA).” PMID 21736751 Jul 2011
Modality Monoclonal antibody “Canakinumab is a fully human anti-interleukin IL-1beta monoclonal antibody, being investigated for the treatment of rheumatoid arthritis (RA).” PMID 21736751 Jul 2011
Route Intravenous “administered via intravenous infusion” NCT00421226
Target IL1B “Canakinumab, a fully human anti-IL-1β antibody, produces sustained selective inhibition of IL-1β.” PMID 21356079 Feb 2011