Iscalimab is under clinical development by Novartis and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Iscalimab’s likelihood of approval (LoA) and phase transition for Sicca Syndrome (Sjogren) took place on 25 Nov 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Iscalimab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Iscalimab overview

Iscalimab is under development for the treatment of type 1 diabetes mellitus,  myasthenia gravis, primary Sjogren's syndrome, lupus nephritis and moderate to severe hidradenitis suppurativa. The drug candidate is administered through intravenous and subcutaneous routes. The drug candidate is an anti-CD40 monoclonal antibody. It was under development for the treatment of Grave's hyperthyroidism and rheumatoid arthritis. It was under development for the treatment of kidney transplant rejection and liver transplant rejection.

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, 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.

Quick View Iscalimab LOA Data

Report Segments
  • Innovator
Drug Name
  • Iscalimab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Dermatology
  • Hormonal Disorders
  • Immunology
  • Metabolic Disorders
Key Developers
  • Sponsor Company: Novartis
  • Originator: Chiron
Highest Development Stage
  • Phase II

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.