• Originator Novartis
• Developer Charite - Universitatsmedizin Berlin; 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

Highest Development Phases

• 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; Triple negative breast cancer
• Discontinued Asthma; Diabetic retinopathy; Polymyalgia rheumatica; Rheumatoid arthritis; Type 1 diabetes mellitus; Type 2 diabetes mellitus

Most Recent Events

• 26 Jan 2026 Novartis Pharmaceuticals terminates the phase III CANOPY-1 trial in Non-small cell lung cancer (Combination therapy, First-line therapy, In the elderly, In adults, Late-stage disease, Metastatic disease) in Vietnam, United Kingdom, Turkey, Thailand, Taiwan, Switzerland, Sweden, South Africa, Slovakia, Singapore, Russia, Romania, Portugal, Poland, Philippines, Peru, Norway, Mexico, Malaysia, Lebanon, Japan, Italy, India, Hungary, Hong Kong, Guatemala, Greece, France, Finland, England, Denmark, Czech Republic, Colombia, China, Chile, Canada, Brazil, Austria, Australia, Argentina (SC), due to results of primary analysis showed addition of canakinumab to combination treatment did not improve tumour response or overall survival; the decision to stop the trial was not due to safety concerns (NCT03631199)
• 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)