BARCELONA, Spain, July 16, 2026
Grifols announced that the first patients have been dosed in two Phase 3 clinical trials designed to expand the U.S. indications of its flagship immunoglobulin therapies, GAMUNEX®-C and XEMBIFY®. The SIGMA study will evaluate intravenous immunoglobulin (IVIG) GAMUNEX-C in patients with secondary immunodeficiency (SID) associated with hematologic cancers, while the XPERT study will assess whether subcutaneous immunoglobulin (SCIg) XEMBIFY is non-inferior to GAMUNEX-C for maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). Both studies are intended to support U.S. label expansion and provide patients with additional treatment options for immune-related disorders.
SIGMA Trial Targets Secondary Immunodeficiency in Blood Cancer Patients
The Phase 3 SIGMA trial (NCT07582432) is evaluating the pharmacokinetics, efficacy, and safety of GAMUNEX-C combined with standard medical treatment to prevent serious bacterial infections in patients with secondary immunodeficiency resulting from hematologic malignancies such as chronic lymphocytic leukemia (CLL), multiple myeloma (MM), and non-Hodgkin lymphoma (NHL). The open-label, multicenter study will enroll approximately 50 patients and aims to demonstrate that serious bacterial infection rates remain below one per patient-year. Successful results could expand GAMUNEX-C’s approved U.S. indications to include SID associated with blood cancers.
XPERT Study Evaluates XEMBIFY for CIDP Maintenance Therapy
The XPERT Phase 3 trial (NCT07540221) is designed to compare the pharmacokinetic profile, efficacy, and safety of XEMBIFY with GAMUNEX-C in approximately 40 patients with CIDP across multiple sites in the United States and Europe. The study seeks to establish non-inferiority between the two immunoglobulin therapies, potentially supporting regulatory discussions for expanding XEMBIFY’s U.S. label to include CIDP. If successful, the trial could provide patients with a more flexible subcutaneous treatment option for this chronic autoimmune neurological disorder.
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Grifols Strengthens Growing Immunoglobulin Franchise
The new studies complement Grifols’ ongoing EXCELL Phase 3 trial evaluating XEMBIFY in patients with hypogammaglobulinemia and recurrent infections associated with blood cancers. Together, these clinical programs reinforce the company’s strategy to broaden the clinical applications of its immunoglobulin portfolio while addressing growing global demand for plasma-derived therapies. Grifols expects the expanded indications to strengthen its leadership in immunology by offering both intravenous and subcutaneous treatment options across a wider range of immune system disorders.
Source: Grifols press release
