Immune globulin 10% - Grifols
Alternative Names: Gammaked; Gamunex; Gamunex-C; Gamunex-IGIV; IGIV; Intravenous gammaglobulin; IVIG; IVIG 10% - Kedrion; Kedrion Immunoglobulin 10%; Kedrion IVIG 10%; KIg10; TAL-05-0002Latest Information Update: 07 Jan 2025
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- 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
Most Recent Events
- 30 Dec 2024 Kedrion plans a phase III trial for Chronic inflammatory demyelinating polyradiculoneuropathy (IV) in September 2025 (NCT06752356)
- 24 Oct 2024 Therapeutic, pharmacokinetic and adverse events data from a phase III trial in Primary Immunodeficiency presented at the (2024 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI-2024)
- 04 Jan 2024 Immune globulin is still in phase III trial in Immunodeficiency disorders (In adolescents, In children) in Hungary, Slovakia, Italy (IV)