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Drug intelligence / Profile preview
IgM-enriched polyclonal immunoglobulin
- Development stage
- Phase 3
- Lead developer
- Biotest
- Modality
- Antibody-Based Therapeutics
- Administration
- Intravenous
01
Overview
IgM-enriched polyclonal immunoglobulin (marketed under the brand name Pentaglobin) is a human plasma-derived intravenous immunoglobulin (IVIG) preparation enriched with IgM (~12%) and IgA (~12%) in addition to IgG (~76%). Developed and manufactured by Biotest (a subsidiary of Grifols), it is designed to provide a broader immunological profile than standard IVIG preparations, which contain at least 96% IgG. The IgM component provides superior neutralization of bacterial endotoxins (lipopolysaccharides) and enhanced complement activation, while the IgA and IgG components support pathogen opsonization and anti-inflammatory immunomodulation. It is primarily indicated as an adjunctive therapy for severe bacterial infections, sepsis, and septic shock, as well as for immunoglobulin replacement in immunocompromised patients. Currently, a Phase 3 trial sponsored by Azienda Ospedaliero-Universitaria di Modena is evaluating a personalized dosing strategy based on serum IgM titers versus standard flat dosing in adults with septic shock.
- Brand names
- Pentaglobin
- Other names
- IgM-enriched immunoglobulinIgM-enriched human normal immunoglobulinIVIgGMIgGAMIVIGMApentaglobulin
02
Targets
C3b (Complement Component 3b)FCAR (Fc alpha receptor I)FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)FCMR (Fc mu receptor)C3
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