Takeda’s TAK-881-3001 pivotal Phase II/III clinical trial of TAK-881 in patients with primary immunodeficiency disease (PID) has met its primary endpoint.

The study demonstrated pharmacokinetic comparability between TAK-881, an Immune Globulin Subcutaneous (Human) 20% Solution with Recombinant Human Hyaluronidase, and Hyqvia.

According to Takeda, TAK-881’s efficacy, tolerability, and safety profiles were found to be comparable to Hyqvia.

The therapy’s ability to deliver the required immunoglobulin dose in half the volume of Hyqvia could reduce infusion duration while maintaining a flexible dosing schedule of every three or four weeks.

The trial assessed efficacy, immunogenicity, pharmacokinetics, safety and tolerability of TAK-881 in adults and children aged two years and older with PID who were previously treated with immunoglobulin therapy.

These results were compared to Hyqvia in patients aged 16 years and above. TAK-881 achieved a geometric mean ratio of 99.67% for immunoglobulin G (IgG) exposure during one dosing interval at steady state.

The data show that TAK-881 provided immune protection comparable to Hyqvia, maintaining protective IgG levels during the study, with similar infection rates.

Safety and tolerability profiles were also comparable, and no new safety signals were reported. The safety profile of TAK-881 will be further evaluated in the ongoing TAK-881-3002 extension study.

The company plans to continue analyses from TAK-881-3001 and share further findings at an upcoming medical forum. Regulatory submissions in the US, European Union, and Japan are anticipated for fiscal year 2026.

Takeda plasma-derived therapies research and development senior vice-president and head Kristina Allikmets said: “These Phase II/III results showed the pharmacokinetic profile of TAK-881 was comparable to Hyqvia, an established IG standard of care in patients with PID, while offering the potential advantages of fewer injection sites, a flexible treatment schedule and shorter infusion times.

“TAK-881-3001 reflects our broader R&D commitment to advancing next-generation IG therapies and bringing meaningful new treatment options to patients faster while expanding patient choice and upholding rigorous standards of efficacy and safety.”