IMAAVY

LaunchGene

nipocalimab

BLAINJECTIONINJECTABLEPriority Review
Approved
Apr 2025
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
19

Mechanism of Action

Nipocalimab-aahu is a human IgG1 monoclonal antibody that binds to neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG levels.

Clinical Trials (5)

NCT07438496Phase 3Recruiting

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Started Mar 2026
600 enrolled
Lupus Erythematosus, Systemic
NCT04883619Phase 2Withdrawn

A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

Started Jan 2026
0
Lupus Nephritis
NCT07217587Phase 3Recruiting

Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis

Started Jan 2026
115 enrolled
Myasthenia Gravis
NCT06533098Phase 3Recruiting

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Started Feb 2025
50 enrolled
Thrombocytopenia, Neonatal Alloimmune
NCT06741969Phase 3Active Not Recruiting

Nipocalimab in Moderate to Severe Sjogren's Disease

Started Dec 2024
655 enrolled
Sjogrens Syndrome