Drug intelligence / Profile preview

nipocalimab + certolizumab

Development stage
Unknown
Lead developer
Janssen Research & Development
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics
Administration
Intravenous, Subcutaneous
01

Overview

Nipocalimab + certolizumab is a combination of two monoclonal antibodies investigated as a therapy for moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response to prior advanced therapies. **Nipocalimab** is a fully human, effectorless IgG1 monoclonal antibody that targets and blocks neonatal Fc receptor (FcRn), decreasing the recycling of IgG and consequently lowering circulating IgG, including autoantibodies involved in autoimmune diseases. **Certolizumab** is a PEGylated Fc-free anti-TNF-alpha monoclonal antibody fragment that neutralizes both soluble and membrane-bound tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory cytokine implicated in RA pathogenesis. The combination therapy aims to reduce RA disease activity through complementary mechanisms: depletion of pathogenic IgG autoantibodies by nipocalimab and suppression of inflammation via TNF-alpha blockade by certolizumab. As of the most recent data, this combination is in Phase 2 evaluation for RA with no established marketing approval[1][3][7].

Brand names
Cimzia
Other names
certolizumab-Janssen Research & Development, LLC-rheumatoid arthritisnipocalimab + certolizumabM281 + CDP870
02

Targets

TNFA (Tumor necrosis factor alpha (soluble))FCGRT (Neonatal crystallizable fragment receptor)

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