Drug Profile

Canakinumab - Novartis

Alternative Names: ACZ-885; Anti-IL-1 beta monoclonal antibody; Antibody A; Ilaris

Latest Information Update: 28 Apr 2025

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At a glance

Originator Novartis
Developer Charite - Universitatsmedizin Berlin; Columbia University; Novartis; Triemli hospital; University Hospital Tubingen; University Hospital Zurich
Class Anti-inflammatories; Antianaemics; Antigouts; Antihyperglycaemics; Antineoplastics; Antirheumatics; Cardiovascular therapies; Eye disorder therapies; Heart failure therapies; Immunotherapies; Monoclonal antibodies; Vascular disorder therapies
Mechanism of Action Interleukin 1 beta inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Familial Mediterranean fever; Pancreatic cancer; Juvenile rheumatoid arthritis; Inflammation; Cryopyrin-associated periodic syndromes; Peroxisomal disorders; Familial autosomal dominant periodic fever; Adult-onset Still's disease
New Molecular Entity Yes

Marketed Adult-onset Still's disease; Cryopyrin-associated periodic syndromes; Familial autosomal dominant periodic fever; Familial Mediterranean fever; Gouty arthritis; Juvenile rheumatoid arthritis; Peroxisomal disorders
Preregistration Cardiovascular disorders
Phase III Behcet's syndrome; COVID 2019 infections; COVID-19 pneumonia; Cytokine release syndrome; Non-small cell lung cancer
Phase II Abdominal aortic aneurysm; Alzheimer's disease; Atherosclerosis; Heart failure; Malignant melanoma; Mild cognitive impairment; Myelodysplastic syndromes; Osteoarthritis; Peripheral arterial occlusive disorders; Pulmonary sarcoidosis; Respiratory insufficiency; Schnitzler syndrome; Sickle cell anaemia
No development reported Chronic obstructive pulmonary disease; Pancreatic cancer; Renal cell carcinoma; Triple negative breast cancer
Discontinued Asthma; Diabetic retinopathy; Polymyalgia rheumatica; Rheumatoid arthritis; Type 1 diabetes mellitus; Type 2 diabetes mellitus

28 Apr 2025 No recent reports of development identified for phase-I development in Pancreatic-cancer(Combination therapy, Metastatic disease) in USA (SC, Injection)
16 Apr 2025 Novartis completes a phase-III clinical trials in Adult-onset Still's disease in Japan (SC) (NCT04717635)
07 Dec 2024 Pharmacodynamic and adverse events data from a phase II trial in Myelodysplastic neoplasms presented at the 66th American Society of Hematology Annual Meeting and Exposition (ASH-2024)

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