Drug Profile

Immune globulin 10% - Grifols

Alternative Names: Gammaked; Gamunex; Gamunex-C; Gamunex-IGIV; IGIV; Intravenous gammaglobulin; IVIG; IVIG 10% -Grifols; TAL-05-0002

Latest Information Update: 07 Jan 2025

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At a glance

Originator Bayer HealthCare
Developer Bayer HealthCare; Beth Israel Deaconess Medical Center; Grifols; Kedrion; University of Texas Southwestern Medical Center
Class Anti-infectives; Anti-inflammatories; Antibacterials; Antidementias; Antifibrotics; Antivirals; Eye disorder therapies; Immunoglobulins; Immunoproteins; Polyethylene glycols; Serum globulins; Skin disorder therapies; Vascular disorder therapies
Mechanism of Action Amyloid beta-protein inhibitors; Immunostimulants

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Chronic inflammatory demyelinating polyradiculoneuropathy
New Molecular Entity No

Marketed Chronic inflammatory demyelinating polyradiculoneuropathy; Idiopathic thrombocytopenic purpura; Immunodeficiency disorders
Phase III Myasthenia gravis
Phase II COVID 2019 infections; Diabetic neuropathies
Phase I/II Tachycardia
Discontinued Multiple sclerosis

30 Dec 2024 Kedrion plans a phase III trial for Chronic inflammatory demyelinating polyradiculoneuropathy (IV) in September 2025 (NCT06752356)
13 Sep 2023 Grifols Biologicals in collaboration with Beth Israel Deaconess Medical Center terminate a phase II trial in Diabetic neuropathy in USA (IV, Injection) due to funding withdrawn in the midst of the COVID pandemic (NCT02915263)
25 Jul 2022 Grifols withdraws a phase II The MIGHT trial prior to enrolment for Immune-mediated necrotizing myopathy in US in July 2022 (NCT04450654)

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