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 · 11 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansions (5)	US (FDA)	ILARIS	—	2013-05-09 – 2023-08-25	fda.gov ↗
Filed	US (FDA)	—	cardiovascular risk reduction	2018-01-24	“Für ACZ885 (Canakinumab) wurden bei der FDA und EMA ein Ergänzungsantrag (supplemental Biologics License Application) sowie ein Marktzulassungsantrag (Marketing Authorization...” novartis.com ↗ “ACZ885 (canakinumab) pour la réduction du risque cardiovasculaire: une demande supplémentaire de licence de produit biologique et d'autorisation de mise sur le marché a été...” novartis.com ↗ “ACZ885 (canakinumab) submitted supplemental Biologics License Application and Marketing Authorization Application for cardiovascular risk reduction to the FDA and EMA.” novartis.com ↗ “ACZ885 submitted to FDA and EMA for cardiovascular risk reduction” novartis.com ↗
Filed	EU (EMA)	—	cardiovascular risk reduction	2018-01-24	“Für ACZ885 (Canakinumab) wurden bei der FDA und EMA ein Ergänzungsantrag (supplemental Biologics License Application) sowie ein Marktzulassungsantrag (Marketing Authorization...” novartis.com ↗ “ACZ885 (canakinumab) pour la réduction du risque cardiovasculaire: une demande supplémentaire de licence de produit biologique et d'autorisation de mise sur le marché a été...” novartis.com ↗ “ACZ885 (canakinumab) submitted supplemental Biologics License Application and Marketing Authorization Application for cardiovascular risk reduction to the FDA and EMA.” novartis.com ↗ “ACZ885 submitted to FDA and EMA for cardiovascular risk reduction” novartis.com ↗
Filed	US (FDA)	Ilaris	—	2016-04-27	“Based on this study Novartis submitted three supplemental Biologic License Applications in the US to register Ilaris for use in these indications.” novartis.com ↗
Approved	EU (EMA)	Ilaris	—	2009-10-23	europa.eu ↗
Approved	US (FDA)	ILARIS	—	2009-06-17	fda.gov ↗
Rejected (CRL)	US (FDA)	—	cardiovascular risk reduction	—	“ACZ885 (canakinumab) a reçu, en octobre, une lettre de réponse complète («complete response letter») de la FDA concernant une demande supplémentaire d'homologation de produit...” novartis.com ↗ “Für ACZ885 (Canakinumab) erhielt Novartis im Oktober ein vollständiges Antwortschreiben (Complete Response Letter, CRL) der FDA bezüglich des ergänzenden Zulassungsantrags...” novartis.com ↗ “ACZ885 (canakinumab) received a complete response letter (CRL) from FDA in October regarding the supplemental Biologics License Application for cardiovascular risk reduction.” novartis.com ↗

Trials 100 · started per year

today

US approved 2009

EU approved 2009

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
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 Stop: Business
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 Stop: Business
Phase 1	NCT03064854	May 2017 → Jul 2021	non-small cell lung carcinoma	Novartis Pharmaceuticals	Terminated	No outcome recorded Stop: Enrollment
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 · 4 met primary · 8 missed
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 Stop: Enrollment
Phase 2	NCT04795466	Oct 2021 → Mar 2024	Alzheimer disease, cognitive impairment with or without cerebellar ataxia	Novartis Pharmaceuticals	Terminated	Missed primary
Phase 2	NCT04814368	Aug 2021 → Jun 2024	osteoarthritis, knee	Novartis Pharmaceuticals	Terminated	No outcome recorded Stop: Business
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	NCT04239157	Aug 2020 → Dec 2026 expected	chronic myelomonocytic leukemia, myelodysplastic syndrome	M.D. Anderson Cancer Center	Recruiting	Met primary
Phase 2	NCT03968419	Nov 2019 → Apr 2022	non-small cell lung carcinoma	Novartis Pharmaceuticals	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT03484923	Sep 2018 → Dec 2022	melanoma	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT02961218	Apr 2017 → Jun 2019	sickle cell disease	Novartis Pharmaceuticals	Completed	Missed primary
Phase 2	NCT02888080	Dec 2016 → Mar 2019	pulmonary sarcoidosis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT02980263	Nov 2016 → Nov 2017	Kawasaki disease	Novartis Pharmaceuticals	Withdrawn	No outcome recorded
Phase 2	NCT02756650	Jun 2016 → Jan 2019	Behcet disease	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT02272946	Sep 2015 → Feb 2021	HIV infectious disease, cardiovascular disorder	Priscilla Hsue, MD	Completed	No outcome recorded
Phase 2	NCT02007252	Dec 2013 → Oct 2015	abdominal aortic aneurysm	Novartis Pharmaceuticals	Terminated	Missed primary
Phase 2	NCT01805960	Jun 2013 → Dec 2016	atrial fibrillation	University Hospital, Basel, Switzerland	Terminated	No outcome recorded
Phase 2	NCT01731990	Oct 2012 → Aug 2016	peripheral arterial disease	Novartis Pharmaceuticals	Terminated	Missed primary
Phase 2	NCT02204293	Jun 2012 → May 2018	adult-onset Still disease	Charite University, Berlin, Germany	Terminated	Missed primary Stop: Enrollment
Phase 2	NCT01635127	Jun 2012 → Dec 2016	chronic idiopathic urticaria	University of Zurich	Unknown	Missed primary
Phase 2	NCT01390350	Jul 2011 → Dec 2017	Schnitzler syndrome	Charite University, Berlin, Germany	Completed	No outcome recorded
Phase 2	NCT01245127	May → Aug 2011	Schnitzler syndrome	Universitaire Ziekenhuizen KU Leuven	Completed	No outcome recorded
Phase 2	NCT01303380	Mar 2011 → Jul 2014	mevalonate kinase deficiency	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT01322321	Mar → Jun 2011	type 1 diabetes mellitus	Novartis Pharmaceuticals	Withdrawn	No outcome recorded
Phase 2	NCT01364389	Feb 2011 → Jan 2013	inflammatory disease, polymyalgia rheumatica	Novartis Pharmaceuticals	Terminated	No outcome recorded
Phase 2	NCT01302795	Feb 2011 → Aug 2014	pyoderma gangrenosum	University of Zurich	Completed	No outcome recorded
Phase 2	NCT01276522	Jan → May 2011	Schnitzler syndrome	Radboud University Medical Center	Completed	No outcome recorded
Phase 2	NCT01148797	Dec 2010 → Feb 2012	familial Mediterranean fever	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT01250171	Nov 2010 → Sep 2011	dry eye syndrome	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT00947427	Oct 2010 → Apr 2013	type 1 diabetes mellitus	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Completed	Missed primary
Phase 2	NCT01242813	Oct 2010 → Jun 2014	TNF receptor 1-associated periodic fever syndrome	Novartis Pharmaceuticals	Completed	Met primary
Phase 2	NCT01170936	Jul 2010 → Sep 2011	urticaria, vasculitis	Charite University, Berlin, Germany	Completed	No outcome recorded
Phase 2	NCT01160822	Apr 2010 → Jul 2011	osteoarthritis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT01088880	Apr 2010 → Aug 2011	familial Mediterranean fever	Novartis Pharmaceuticals	Completed	Met primary
Phase 2	NCT01068860	Feb → Aug 2010	glucose intolerance, type 2 diabetes mellitus	Novartis	Completed	No outcome recorded
Phase 2	NCT00995930	Dec 2009 → Feb 2014	atherosclerosis, prediabetes syndrome, type 2 diabetes mellitus	Novartis Pharmaceuticals	Completed	Missed primary
Phase 2	NCT00927810	Jun 2009 → Aug 2010	gout	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT00819585	Dec 2008 → Aug 2010	gout	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT00798369	Nov 2008 → Aug 2009	gout	Novartis	Completed	No outcome recorded
Phase 2	NCT00663169	Apr 2008 → Oct 2009	gout	Novartis	Completed	No outcome recorded
Phase 2	NCT00605475	Dec 2007 → Sep 2010	type 2 diabetes mellitus	Novartis	Completed	No outcome recorded
Phase 2	NCT00554606	Oct 2007 → Aug 2009	rheumatoid arthritis	Novartis	Completed	No outcome recorded
Phase 2	NCT00504595	May 2007 → Sep 2008	rheumatoid arthritis	Novartis	Completed	No outcome recorded
Phase 2	NCT00487825	Mar 2007 → Dec 2008	rheumatoid arthritis	Novartis	Completed	No outcome recorded
Phase 2	NCT00424346	Nov 2006 → Sep 2008	rheumatoid arthritis	Novartis	Completed	Met primary
Phase 2	NCT00487708	Jan 2005 → Jul 2008	autoinflammatory syndrome	Novartis Pharmaceuticals	Completed	No outcome recorded

Phase 2/32 trials · 1 missed
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	Missed primary
Phase 331 trials · 5 met primary · 5 missed
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	Missed primary
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	Missed primary
Phase 3	NCT03631199	Dec 2018 → Aug 2021	non-small cell lung carcinoma	Novartis Pharmaceuticals	Terminated	Missed primary
Phase 3	NCT03447769	Mar 2018 → Mar 2022	non-small cell lung carcinoma	Novartis Pharmaceuticals	Terminated	Missed primary
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 3	NCT02334748	Nov 2014 → Aug 2018	hereditary periodic fever syndrome, systemic-onset juvenile idiopathic arthritis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT02059291	Jun 2014 → Jul 2017	hereditary periodic fever syndrome	Novartis Pharmaceuticals	Completed	Met primary
Phase 3	NCT01676948	Jan 2013 → Jan 2015	systemic-onset juvenile idiopathic arthritis	Novartis Pharmaceuticals	Withdrawn	No outcome recorded
Phase 3	NCT01593527	Sep 2012	gout	Novartis Pharmaceuticals	Withdrawn	No outcome recorded
Phase 3	NCT01576367	Jan 2012 → Oct 2015	CINCA syndrome, Muckle-Wells syndrome, familial cold autoinflammatory syndrome	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT01470989	Nov 2011 → May 2013	gout	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT01431638	Aug 2011 → May 2013	gout	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT01362608	Jun 2011 → May 2015	gout	Novartis Pharmaceuticals	Terminated	Met primary
Phase 3	NCT01356602	May 2011 → Sep 2012	gout	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT01327846	Apr 2011 → Mar 2017	atherosclerosis	Novartis Pharmaceuticals	Completed	Met primary
Phase 3	NCT01302860	Nov 2010 → Nov 2014	CINCA syndrome, Muckle-Wells syndrome, familial cold autoinflammatory syndrome	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT01105507	Aug 2010 → May 2012	cryopyrin-associated periodic syndrome	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT01080131	Mar → Nov 2010	gout	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT01029652	Dec 2009 → Oct 2010	gout	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00991146	Oct 2009 → Feb 2012	CINCA syndrome, Muckle-Wells syndrome, familial cold autoinflammatory syndrome	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00891046	Sep 2009 → Dec 2014	systemic-onset juvenile idiopathic arthritis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00889863	Jul 2009 → Sep 2011	systemic-onset juvenile idiopathic arthritis	Novartis Pharmaceuticals	Completed	Met primary
Phase 3	NCT00886769	Jul 2009 → Dec 2010	systemic-onset juvenile idiopathic arthritis	Novartis Pharmaceuticals	Terminated	Met primary
Phase 3	NCT00770601	Jan 2009 → Feb 2011	CINCA syndrome	Novartis Pharmaceuticals	Terminated	Missed primary
Phase 3	NCT00685373	May 2008 → Apr 2010	Muckle-Wells syndrome, familial cold autoinflammatory syndrome	Novartis	Completed	No outcome recorded
Phase 3	NCT00465985	Apr 2007 → Oct 2008	Muckle-Wells syndrome	Novartis	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
Comparator or background therapy7 trials
Phase 1	NCT06481189 Comparator	Sep 2022 → Mar 2023	—	AO GENERIUM	Completed	No outcome recorded
Phase 1/2	NCT00619905 Comparator	Dec 2003 → Aug 2005	rheumatoid arthritis	Novartis	Completed	No outcome recorded
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 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

News releases announcing trial results or a regulatory action · 11

Date	Issuer	Release
2022-10-25	The Medicines Company	Results Novartis maintient sa dynamique de croissance et confirme les prévisions de l’exercice 2022 pour le Groupe novartis.com ↗ L’essai CANOPY-A de phase III n’a pas satisfait à son critère principal de survie sans récidive quand il était administré en tant qu’adjuvant chez les patients atteints d’un CPNPC complétement réséqué aux stades II-IIIA et IIIB.
2022-08-15	Novartis Pharmaceuticals	Results Novartis provides update on Phase III CANOPY-A study evaluating canakinumab as adjuvant treatment in non-small cell lung cancer novartis.com ↗ Phase III CANOPY-A trial did not meet primary endpoint of disease-free survival in patients with stages II-IIIA and IIIB completely resected non-small cell lung cancer
2021-10-25	Novartis Pharmaceuticals	Results Novartis top-line results for CANOPY-1 Phase III study support further evaluation of canakinumab in lung cancer novartis.com ↗ CANOPY-1 Phase III study did not meet its primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC)
2021-03-09	Novartis Pharmaceuticals	Results 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 ↗ Novartis announced today the Phase III CANOPY-2 study evaluating canakinumab (ACZ885), an inhibitor of interleukin-1beta (IL-1β), in combination with the chemotherapy agent docetaxel, did not meet its primary endpoint of overall survival (OS) 1 .
2020-11-06	Novartis Pharmaceuticals	Results Novartis provides update on CAN-COVID trial in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome (CRS) novartis.com ↗ The trial did not meet its key secondary endpoint of reducing the COVID-19-related death rate during the 4-week period after treatment 1 .
2017-11-13	Novartis Pharmaceuticals	Results Novartis canakinumab (ACZ885) reduced cardiovascular risk by 25% in subgroup of CANTOS Phase III trial participants novartis.com ↗ Subgroup of patients had a 25% reduction in major adverse cardiovascular events when treated with canakinumab in a new analysis of Phase III CANTOS trial presented at the American Heart Association Scientific Sessions 2017[1]
2017-08-27	Novartis Pharmaceuticals	Results Novartis Phase III CANTOS study demonstrates that targeting inflammation with ACZ885 reduces cardiovascular risk novartis.com ↗ The study showed that ACZ885 led to a statistically significant 15% reduction in the risk of major adverse cardiovascular events (MACE), a composite of non-fatal heart attack, non-fatal stroke and cardiovascular death, compared to placebo (p-value 0.021).
2017-08-27	Novartis Pharmaceuticals	Results 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 ↗ An additional pre-planned analysis showed that ACZ885 reduced the rate of lung cancer incidence and mortality among study participants.
2016-12-16	Novartis Pharmaceuticals	Regulatory Novartis receives positive CHMP recommendation for Ilaris® to treat rare diseases in adults and children called Periodic Fever Syndromes novartis.com ↗ Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Ilaris ® (canakinumab) in Europe to treat three rare and distinct Periodic Fever Syndromes.
2016-09-23	Novartis Pharmaceuticals	Regulatory Novartis receives three new FDA approvals for the expanded use of Ilaris treating rare Periodic Fever Syndrome conditions novartis.com ↗ Novartis announced today that the US Food and Drug Administration (FDA) has granted three simultaneous approvals for the expanded use of Ilaris ® (canakinumab) to treat three rare and distinct types of Periodic Fever Syndromes.
2016-04-27	Novartis Pharmaceuticals	Regulatory Novartis receives three FDA Breakthrough Therapy Designations for Ilaris to treat rare types of Periodic Fever Syndromes novartis.com ↗ Novartis announced today that the US Food and Drug Administration (FDA) has granted three Breakthrough Therapy Designations for Ilaris ® (canakinumab) to treat three rare types of Periodic Fever Syndromes, also known as Hereditary Periodic Fevers[1].

All press releases naming this drug 13 releases

Date	Issuer	Release
2022-10-25	The Medicines Company	Novartis maintient sa dynamique de croissance et confirme les prévisions de l’exercice 2022 pour le Groupe novartis.com ↗
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 ↗
2020-11-06	Novartis Pharmaceuticals	Novartis provides update on CAN-COVID trial in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome (CRS) 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.

Field	Value	Cited 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 ↗ NCT01589029 ↗ NCT01431638 ↗ NCT05401578 ↗ NCT01080131 ↗ NCT00991146 ↗ Show 77 more sources
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 ↗ “An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis” NCT00891046 ↗ “Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks.” NCT01576367 ↗ “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 ↗ Show 23 more sources
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 ↗ NCT06481189 ↗ NCT06497491 ↗
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