Overview
Pentaglobin, also known as IgM-enriched immunoglobulin, falls under a group of polyclonal immunoglobulin preparations. It is comprised of immunoglobulin G (IgG) and immunoglobulin A (IgA) while also being enriched by immunoglobulin M (IgM).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Pentaglobin (IgM-Enriched Immunoglobulin): A Comprehensive Pharmacological and Clinical Review
Section I: Introduction and Drug Identification
Overview and Rationale
Pentaglobin is a polyclonal, human plasma-derived immunoglobulin preparation for intravenous administration, distinguished by its enrichment with Immunoglobulin M (IgM) and Immunoglobulin A (IgA).[1] Unlike standard intravenous immunoglobulin (IVIg) products, which are composed almost exclusively of Immunoglobulin G (IgG), Pentaglobin is specifically formulated to contain a balanced spectrum of the three major immunoglobulin classes.[3] This composition is intentionally designed to more closely approximate the physiological distribution of immunoglobulins found in the serum of healthy individuals, thereby providing a broader and more dynamic range of immunological activity.[3]
The fundamental therapeutic rationale for Pentaglobin is rooted in the unique biological properties of its enriched components, particularly IgM. As the first-line antibody in the primary immune response, IgM possesses exceptionally potent antibacterial and immunomodulatory capabilities that are crucial in the acute phase of an infection.[3] By harnessing these properties, Pentaglobin is positioned primarily as an adjunctive therapy for the treatment of severe bacterial infections, where it aims to supplement antibiotic therapy by rapidly neutralizing pathogens and their toxins while helping to rebalance a dysregulated host immune response.[1] The descriptive classifications "IgM-enriched immunoglobulins" and "IVIgGM" are therefore not merely synonyms but functional descriptors that highlight a fundamental therapeutic distinction from the broader, IgG-dominant IVIg category, signifying a targeted strategy for acute infection modulation rather than chronic antibody replacement.[1]
Historical Context
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2020/04/17 | Phase 2 | UNKNOWN | |||
2019/08/01 | Phase 3 | UNKNOWN | |||
2018/04/11 | Phase 2 | Active, not recruiting | Gruppo Italiano Trapianto di Midollo Osseo | ||
2016/01/13 | Phase 2 | Completed | Università Politecnica delle Marche | ||
2009/11/01 | Phase 4 | UNKNOWN | Zekai Tahir Burak Women's Health Research and Education Hospital |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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