Nipocalimab

DB16257ApprovedInvestigationalProtein Based Therapies

Nipocalimab is an intravenous aglycosylated human IgG1 anti-FcRn monoclonal antibody indicated for generalized myasthenia gravis and warm autoimmune hemolytic anemia, lowering circulating IgG and pathogenic autoantibodies by blocking FcRn-mediated IgG recycling. Nipocalimab-aahu is a neonatal Fc receptor (FcRn) blocker used to treat certain antibody-mediated autoimmune diseases.

Mechanism
Curator reviewed · 5 references
Primary indication
Nipocalimab is indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.Curator reviewed · 3 structured indications
Formula / weight
142000.0 Da (approximate)
First approval
Canada, 2025 · United States, 2025 · European Union, 2025
Also known as
immunoglobulin G1-lambda, anti-[Homo sapiens FCGRT (Fc fragment of IgG receptor and transporter, neonatal Fc receptor, FcRn, transmembrane alpha chain of the neonatal receptor)], Homo sapiens monoclonal antibody (gamma1 heavy chain Homo sapiens (1-445) · Immunoglobulin g1, anti-(human neonatal fc receptor) (human monoclonal m281 .gamma.-1 chain), disulfide with human monoclonal m281 .lambda.-chain, dimer
Code names
JNJ-80202135 · JNJ-86507083 · M-281
Brand names
  • Imaavy

Resolves to

Clinical / RWD

What you can answer from here — as of September 02, 2026

1Protein targetEach mapped to UniProt, with action and pharmacological action
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663Drug interactionsStructured to mechanism, not free text
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16Clinical trialsPhase, status and sponsor resolved per trial
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3Structured indicationsCondition, population, route and combination as fields, not prose
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1ContraindicationEach with its own population and attribute set
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6Marketed productsAcross 3 countries and 3 labellers
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10+ReferencesStructured and connected to the statements they support
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