Drug intelligence / Profile preview

Gamimune-N

Development stage
Phase 3
Lead developer
Bayer
Modality
Recombinant Proteins and Enzymes, Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Gamimune-N is a sterile, non-pyrogenic solution of human immunoglobulin G (IgG) for intravenous administration (IVIG). Prepared from large pools of human plasma using a cold ethanol fractionation process, it contains a broad spectrum of antibodies against various infectious agents. It was notably the first liquid IVIG product stabilized at a low pH (approximately 4.25) to prevent IgG aggregation and maintain biological activity without the need for added sugars like maltose or sucrose, which are often associated with renal complications. Gamimune-N functions both as a replacement therapy for patients with primary immunodeficiencies—restoring protective antibody levels—and as an immunomodulatory agent in autoimmune disorders such as idiopathic thrombocytopenic purpura (ITP). Its immunomodulatory effects are primarily mediated through the blockade of Fc gamma receptors on macrophages, neutralization of autoantibodies, and interference with the complement cascade.

Brand names
Gamimune-NGamimune
Other names
Immune Globulin Intravenous (Human)IGIVIVIGHuman intravenous immunoglobulinGamimune-N 10%Gamimune-N 5%
02

Targets

FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)Id (Tumor-specific idiotype immunoglobulin)

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