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iscalimab   Click here for help

GtoPdb Ligand ID: 9802

Synonyms: CFZ-533 | CFZ533 | NVP-CFZ533 | OM11-62MF
Immunopharmacology Ligand
Compound class: Antibody
Comment: Iscalimab (CFZ533) is a Fc-silent anti-CD40 monoclonal antibody that is designed exhibit no agonist activity and is non-depleting (no ADCC activity for an improved safety profile, particularly in non-oncologic indications) [1,8]. It is claimed in Novartis' patent WO2012065950 [6] as mAb1 (based on peptide sequence alignments between the INN record for iscalimab and patented sequences retrieved from a BLAST search). Blocking CD40-mediated inflammatory responses is a well advanced mechanism being expoited for potential to treat autoimmune and inflammatory disorders and/or for preventing/reducing graft rejection following organ transplant.
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Ligand Activity Visualisation Charts

These are box plot that provide a unique visualisation, summarising all the activity data for a ligand taken from ChEMBL and GtoPdb across multiple targets and species. Click on a plot to see the median, interquartile range, low and high data points. A value of zero indicates that no data are available. A separate chart is created for each target, and where possible the algorithm tries to merge ChEMBL and GtoPdb targets by matching them on name and UniProt accession, for each available species. However, please note that inconsistency in naming of targets may lead to data for the same target being reported across multiple charts.

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View interactive charts of activity data across species
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Summary of Clinical Use Click here for help
iscalimab (CFZ533) was evaluated in clinical trials as a therapy for some autoimmune conditions and for preventing/reducing solid organ transplant rejection. Click here to link to ClinicalTrials.gov's full list of CFZ533 trials. Novartis discontinued development of iscalimab in 2025.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT02089087 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients Phase 1 Interventional Novartis 2
NCT02713256 A Study to Evaluate the Safety and Effect of CFZ533 on Patients With Graves' Disease Phase 2 Interventional Novartis 7
NCT02291029 Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome Phase 2 Interventional Novartis 4
NCT02565576 Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis Phase 2 Interventional Novartis 5
NCT03905525 Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome Phase 2 Interventional Novartis 3
NCT03663335 Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients Phase 2 Interventional Novartis The CIRRUS I study.