GAMUNEX-C

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

2 competitors in CIDP

#DrugCompanyPhaseTrials

1

Xembify

Grifols Therapeutics LLC

Phase 3

12

GAMUNEX-C

Grifols Therapeutics LLC

Phase 3

1

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Immunodeficiency2 trials

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency

Completed·Grifols Therapeutics LLC·Phase 3·NCT04561115·33 enrolled

Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency

Completed·Grifols Therapeutics LLC·Phase 4·NCT01465958·12 enrolled

COVID-191 trial

Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)

Completed·Grifols Therapeutics LLC·Phase 2·NCT04480424·100 enrolled

Corneal Neovascularization1 trial

Subconjunctival IVIg (Gamunex-C) Injection for Corneal Neovascularization and Inflammatory Conditions

Withdrawn·UUniversity of Utah·Phase 1·NCT02042027

Myopathy1 trial

Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment (The MIGHT Trial)

Withdrawn·UUniversity of Washington·Phase 2·NCT04450654

CIDP1 trial

An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Recruiting·Grifols Therapeutics LLC·Phase 3·NCT07540221·40 enrolled

Details

Drug Info

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