Canakinumab

Summary

Canakinumab (CHEMBL1201834) is an approved antibody (ATC L04AC08); indicated across 44 conditions including juvenile idiopathic arthritis and gout.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L04AC08
• Indications: 44 conditions
• Clinical trials: 98

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1201834
Name	Canakinumab
Type	Antibody
Max phase	4
ATC	L04AC08

Also known as: ACZ-885, ACZ885, Canakinumab, Ilaris, CANAKINUMAB

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

6 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
juvenile idiopathic arthritis	4	MONDO:0011429	EFO:0002609
gout	4	MONDO:0005393	EFO:0004274
immune system disorder	4	MONDO:0005046	EFO:0000540
cryopyrin-associated periodic syndrome	4	MONDO:0016168	MONDO:0008633
mevalonate kinase deficiency	4	MONDO:0017708	MONDO:0017708
familial Mediterranean fever	4	MONDO:0018088	MONDO:0018088

32 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
atherosclerosis	3	MONDO:0005311	EFO:0003914
non-small cell lung carcinoma	3	MONDO:0005233	EFO:0003060
adult-onset Still disease	3	MONDO:0019355	EFO:0007135
lung carcinoma	3	MONDO:0005138	EFO:0001071
pneumonia	3	MONDO:0005249	EFO:0003106
severe acute respiratory syndrome	3	MONDO:0005091	MONDO:0100096
hypoglycemia	3	MONDO:0004946	HP:0001943
lung neoplasm	3	MONDO:0021117	MONDO:0008903
exocrine pancreatic carcinoma	3	MONDO:0005192	EFO:0002618
pyoderma	2	MONDO:0002922	HP:0000999
rheumatoid arthritis	2	MONDO:0008383	EFO:0000685
abdominal aortic aneurysm	2	MONDO:0005350	EFO:0004214
peripheral arterial disease	2	MONDO:0005386	EFO:0004265
atrial fibrillation	2	MONDO:0004981	EFO:0000275
pulmonary sarcoidosis	2	MONDO:0001708	DOID:13406
dry eye syndrome	2	MONDO:0006733	EFO:1000906
Kawasaki disease	2	MONDO:0012727	EFO:0004246
melanoma	2	MONDO:0005105	EFO:0000756
polymyalgia rheumatica	2	MONDO:0019735	EFO:0008518
alcoholic hepatitis	2	MONDO:0001505	EFO:1001345
Behcet disease	2	MONDO:0007191	EFO:0003780
Schnitzler syndrome	2	MONDO:0018304	EFO:1001165
type 1 diabetes mellitus	2	MONDO:0005147	MONDO:0005147
type 2 diabetes mellitus	2	MONDO:0005148	MONDO:0005148
osteoarthritis	2	MONDO:0005178	MONDO:0005178
sickle cell disease	2	MONDO:0011382	MONDO:0011382
osteoarthritis, knee	2	MONDO:0005416	EFO:0004616
chronic obstructive pulmonary disease	1	MONDO:0005002	EFO:0000341
age-related macular degeneration	1	MONDO:0005150	EFO:0001365
breast neoplasm	1	MONDO:0021100	MONDO:0007254
myelodysplastic syndrome	1	MONDO:0018881	EFO:0000198
pancreatic ductal adenocarcinoma	1	MONDO:0005184	MONDO:0005184

5 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 98.

Phase distribution

Phase	Trials
PHASE2	49
PHASE3	28
PHASE1	9
PHASE1/PHASE2	5
Not specified	3
PHASE2/PHASE3	2
PHASE4	1
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05080218	PHASE4	COMPLETED	COVID-19 VaccinE Response in Rheumatology Patients
NCT05401578	PHASE3	RECRUITING	Canakinumab for the Treatment of Postprandial Hypoglycemia
NCT05535738	PHASE2/PHASE3	ACTIVE_NOT_RECRUITING	Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
NCT00465985	PHASE3	COMPLETED	Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome
NCT00685373	PHASE3	COMPLETED	Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
NCT00770601	PHASE3	TERMINATED	Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease
NCT00886769	PHASE3	TERMINATED	Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)
NCT00889863	PHASE3	COMPLETED	Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
NCT00891046	PHASE3	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.
NCT00900146	PHASE2/PHASE3	TERMINATED	Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration in Metformin Monotherapy Treated Type 2 Diabetic Patients
NCT00991146	PHASE3	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
NCT01029652	PHASE3	COMPLETED	Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study
NCT01080131	PHASE3	COMPLETED	Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.
NCT01302860	PHASE3	COMPLETED	Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
NCT01327846	PHASE3	COMPLETED	Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)
NCT01362608	PHASE3	TERMINATED	Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective
NCT01470989	PHASE3	COMPLETED	β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
NCT01576367	PHASE3	COMPLETED	Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
NCT01593527	PHASE3	WITHDRAWN	Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease
NCT01676948	PHASE3	WITHDRAWN	An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
NCT02059291	PHASE3	COMPLETED	Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers
NCT02334748	PHASE3	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
NCT02396212	PHASE3	COMPLETED	Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
NCT02911857	PHASE3	COMPLETED	An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
NCT03447769	PHASE3	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
NCT03626545	PHASE3	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
NCT03631199	PHASE3	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
NCT04362813	PHASE3	COMPLETED	Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia
NCT04510493	PHASE3	COMPLETED	Canakinumab in Patients With COVID-19 and Type 2 Diabetes
NCT04717635	PHASE3	COMPLETED	Study of Efficacy and Safety of Canakinumab in Japanese Patients With AOSD
NCT05725343	PHASE3	TERMINATED	A Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer
NCT04239157	PHASE2	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
NCT04789681	PHASE2	RECRUITING	Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial
NCT04798339	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA
NCT04905316	PHASE2	ACTIVE_NOT_RECRUITING	A Study of Canakinumab With Chemotherapy, Radiation Therapy, and Durvalumab in People With Lung Cancer
NCT05467800	PHASE2	ACTIVE_NOT_RECRUITING	Study of Canakinumab in Patients With Myelofibrosis
NCT05641831	PHASE2	RECRUITING	Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study
NCT06038526	PHASE2	ACTIVE_NOT_RECRUITING	Evaluation of Canakinumab in High-Risk Former-Smokers
NCT06691217	PHASE2	RECRUITING	Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis
NCT07138898	PHASE2	NOT_YET_RECRUITING	Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
NCT00424346	PHASE2	COMPLETED	Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis
NCT00426218	PHASE1/PHASE2	COMPLETED	Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
NCT00487708	PHASE2	COMPLETED	Safety, Efficacy, Pharmacokinetics, Pharmacodynamics of ACZ885 in Patients With NALP3 Mutations and Clinical Symptoms
NCT00487825	PHASE2	COMPLETED	Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis
NCT00504595	PHASE2	COMPLETED	Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid Arthritis
NCT00505089	PHASE1/PHASE2	TERMINATED	Efficacy and Safety of Subcutaneous Versus Intravenous ACZ885 in Adult Patients With Established Rheumatoid Arthritis
NCT00554606	PHASE2	COMPLETED	Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis
NCT00581945	PHASE1/PHASE2	COMPLETED	Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00605475	PHASE2	COMPLETED	Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes
NCT00619905	PHASE1/PHASE2	COMPLETED	Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Rheumatoid Arthritis With Ongoing Treatment With Methotrexate
NCT00663169	PHASE2	COMPLETED	Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
NCT00798369	PHASE2	COMPLETED	Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients
NCT00819585	PHASE2	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)
NCT00927810	PHASE2	COMPLETED	Long Term Study of Canakinumab (ACZ885) in Patients With Gout
NCT00995930	PHASE2	COMPLETED	Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
NCT01068860	PHASE2	COMPLETED	To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies
NCT01088880	PHASE2	COMPLETED	Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever
NCT01148797	PHASE2	COMPLETED	Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)
NCT01160822	PHASE2	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
NCT01170936	PHASE2	COMPLETED	Ilaris® in Urticarial Vasculitis - Investigation of Treatment Responses
NCT01242813	PHASE2	COMPLETED	Efficacy and Safety Study of ACZ885 in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome (TRAPS).
NCT01245127	PHASE2	COMPLETED	Ilaris (Canakinumab) in the Schnitzler Syndrome
NCT01250171	PHASE2	COMPLETED	The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients
NCT01276522	PHASE2	COMPLETED	Efficacy and Safety of Canakinumab in Schnitzler Syndrome
NCT01302795	PHASE2	COMPLETED	Canakinumab for Pyoderma Gangrenosum
NCT01303380	PHASE2	COMPLETED	Canakinumab in Patients With Active Hyper-IgD Syndrome
NCT01322321	PHASE2	WITHDRAWN	ACZ885 in Type 1 Diabetes Mellitus
NCT01364389	PHASE2	TERMINATED	A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
NCT01390350	PHASE2	COMPLETED	Ilaris® Effects in Schnitzler Syndrome (ILESCH)
NCT01635127	PHASE2	UNKNOWN	Efficacy Study of Canakinumab to Treat Urticaria
NCT01731990	PHASE2	TERMINATED	Safety, Tolerability and Efficacy of ACZ885 on Leg Artery Structure in Patients With Peripheral Artery Disease
NCT01805960	PHASE2	TERMINATED	Canakinumab for the Prevention of Recurrences After Electrical Cardioversion: CONVERT-AF
NCT02007252	PHASE2	TERMINATED	ACZ885 for the Treatment of Abdominal Aortic Aneurysm
NCT02204293	PHASE2	TERMINATED	Canakinumab for Treatment of Adult-onset Still’s Disease
NCT02272946	PHASE2	COMPLETED	Effect of IL–1β Inhibition on Inflammation and Cardiovascular Risk
NCT02756650	PHASE2	COMPLETED	1 Year of Treatment With Canakinumab in Behçet’s Disease Patients With Neurologic or Vascular Involvement
NCT02888080	PHASE2	COMPLETED	Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Patients With Pulmonary Sarcoidosis
NCT02961218	PHASE2	COMPLETED	Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia
NCT02980263	PHASE2	WITHDRAWN	Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
NCT03484923	PHASE2	COMPLETED	Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma
NCT03775109	PHASE2	COMPLETED	IL-1 Signal Inhibition in Alcoholic Hepatitis
NCT03968419	PHASE2	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.
NCT04795466	PHASE2	TERMINATED	Study of the Efficacy and Safety of Various Anti-inflammatory Agents in Participants With Mild Cognitive Impairment or Mild Alzheimer’s Disease
NCT04814368	PHASE2	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)
NCT05237713	PHASE2	TERMINATED	Efficacy and Safety of Canakinumab for the Treatment of Anemia in LR-MDS Patients
NCT05984602	PHASE1	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
NCT00421226	PHASE1	COMPLETED	Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Healthy Japanese Male Volunteers
NCT00503022	PHASE1	COMPLETED	Safety and Tolerability of an Intravenous Infusion of ACZ885 in Patients With Wet Age-Related Macular Degeneration
NCT01589029	PHASE1	TERMINATED	A Pilot Study on the Effects of ILARIS® on Patients With Proliferative Diabetic Retinopathy (PDRP)
NCT02775994	PHASE1	UNKNOWN	Ilaris (Canakinumab) in Patient With Periodic Fever, Aphthous Stomatitis, Pharyngitis and Cervical Adenitis (PFAPA)
NCT02900664	PHASE1	COMPLETED	A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)
NCT03064854	PHASE1	TERMINATED	PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients
NCT03742349	PHASE1	TERMINATED	Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).
NCT04810611	PHASE1	TERMINATED	Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS
NCT04028245	EARLY_PHASE1	COMPLETED	A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma
NCT06838143	Not specified	RECRUITING	Ilaris NIS in Korea
NCT04348448	Not specified	TERMINATED	Observational Study, Use of Canakinumab Administered Subcutaneously in the Treatment COVID-19 Pneumonia
NCT04476706	Not specified	NO_LONGER_AVAILABLE	Canakinumab MAP in COVID-19 Pneumonia With CRS

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).