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Also known as IV Gamunex 10%
Gamunex 10% · 1 trial · 2 indications
| Name | Type | Description |
|---|---|---|
| IV Gamunex 10% | DRUG | - |
Inclusion Criteria: * Adult (18 or older) with deficiency in one or more IgG subclasses with documented history of recurrent infections limited to upper or lower respiratory tract, urinary, and/or skin. Exclusion Criteria: * Patients with panhypogammaglobulinemia or selective IgA deficiency.
Gamunex 10% is an investigational therapy developed by Grifols, S.A. (ticker GRFS) for IgG deficiency, a condition in which the immune system does not produce enough immunoglobulin G. It has been studied in a Phase 2 clinical trial in adults with IgG subclass deficiency and recurrent infections.
Gamunex 10% is being studied for the treatment of IgG deficiency, including IgG subclass deficiency with recurrent infections. The research focuses on adults 18 years and older. It is an investigational product and is not established as an approved treatment based on the clinical development data available.
Gamunex 10% is developed by Grifols, S.A., a Spanish healthcare company that trades under the ticker GRFS. Grifols is the sponsor responsible for the clinical development of the product for IgG deficiency and related recurrent infections.
Gamunex 10% is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The completed study enrolled 10 participants and evaluated the product in adults with IgG subclass deficiency and recurrent infections.
Gamunex 10% has been evaluated in the Phase 2 trial NCT00417573, titled Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections. The trial enrolled 10 adults aged 18 years and older in the United States and is completed. It was an uncontrolled study without randomization or double blinding.
Yes, Gamunex 10% is also known as IV Gamunex 10%. Both names refer to the same Grifols, S.A. product studied for IgG deficiency. Readers searching for IV Gamunex 10% will find the same clinical development information, including the completed Phase 2 trial NCT00417573.