Canakinumab is under clinical development by Novartis and currently in Phase II for Myelodysplastic Syndrome. According to GlobalData, Phase II drugs for Myelodysplastic Syndrome have a 30% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Canakinumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Canakinumab overview

Canakinumab (Ilaris / Lasprona / Vyncro) is a fully human monoclonal antibody. It is formulated as powder for solution and solution for subcutaneous route of administration. Ilaris is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older including Familial Cold Autoinflammatory Syndrome (FCAS), tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), Familial Mediterranean Fever (FMF), Muckle-Wells Syndrome (MWS), pancreatic cancer and symptomatic anemia. Ilaris is also approved for systemic onset juvenile idiopathic arthritis in patients aged 2 years and older. Ilaris is also indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks, and for the treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD). Canakinumab is indicated for emergency use in the treatment of COVID-19.

Canakinumab (Ilaris) is under development for the treatment of myelodysplastic syndromes, mild cognitive impairment due to Alzheimer's disease, adult onset still's disease (AOSD), renal cell carcinoma, metastatic non-squamous (adjuvant and first line therapy), metastatic triple negative breast cancer, pulmonary sarcoidosis, metastatic melanoma, alcoholic hepatitis and pain associated with sickle cell anemia patients. It was under development for the treatment of arterial structure, function in intermittent claudication patients, gouty arthritis (in the US), abdominal aortic aneurysms, choroidal neovascularization, rheumatoid arthritis, type 1 diabetes, type 2 diabetes, chronic obstructive pulmonary disease (COPD), feratoconjunctivitis sicca (dry eye), secondary prevention of cardiovascular events, Kawasaki disease, urticaria vasculitis, polymyalgia rheumatica, non-small cell lung cancer (second line and third line therapy) and knee osteoarthritis. It is also administered through intraarticular route. It was also under development for the treatment of COVID-19-induced pneumonia, cytokine release syndrome and squamous non-small cell lung cancer (first line therapy), Behcet disease.

Novartis overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

For a complete picture of Canakinumab’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.