Drug intelligence / Profile preview

nipocalimab

Development stage
Approved
Lead developer
Janssen Research & Development
Modality
Recombinant Proteins and Enzymes, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Nipocalimab is a fully human aglycosylated effectorless IgG1 monoclonal antibody that acts as a high-affinity antagonist of the neonatal Fc receptor (FcRn). By binding to FcRn, it blocks the recycling and prolongation of immunoglobulin G (IgG) antibodies in circulation. This leads to reduced levels of pathogenic IgG autoantibodies implicated in autoimmune diseases. Nipocalimab is approved for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients aged 12 years and older who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. It is also under investigation for several other autoimmune and alloimmune conditions including hemolytic disease of the fetus and newborn (HDFN), warm autoimmune hemolytic anemia (wAIHA), chronic inflammatory demyelinating polyneuropathy (CIDP), idiopathic inflammatory myopathy, Sjögren's disease, systemic lupus erythematosus, rheumatoid arthritis, and neonatal alloimmune thrombocytopenia[1][5][8][9].

Brand names
Imaavy
Other names
anti-FcRn monoclonal antibodyNipocalimab aahuNipocalimab-aahu
02

Targets

FCGRT (Neonatal crystallizable fragment receptor)

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