Healthcare company Takeda (TSE: 4502) (NYSE: TAK) on Wednesday reported detailed results from its pivotal Phase 2/3 IgGNITE trial of investigational TAK-881 for primary immunodeficiency disease (PID), demonstrating comparable pharmacokinetics to HYQVIA in patients aged 16 and over. The findings were presented at the European Society for Immunodeficiencies 2026 meeting in Maastricht.

TAK-881 delivered equivalent immunoglobulin dosing in 50% less volume, reducing median infusion times by 56.2 minutes with one infusion site and 27.7 minutes with two sites compared with HYQVIA. The therapy is designed to support dosing every three to four weeks, potentially reducing treatment burden for patients requiring long-term immunoglobulin replacement.

In descriptive analyses, infection outcomes and safety and tolerability were comparable to HYQVIA, with no new safety signals identified. Takeda is continuing long-term safety evaluation through an extension study.

The company expects to submit regulatory applications for TAK-881 in the US, European Union and Japan during fiscal year 2026.