Takeda’s TAK-881 Meets Primary Endpoint in PID Trial

Takeda Pharmaceutical Company has announced positive results from its pivotal Phase II/III TAK-881-3001 trial, with its investigational therapy TAK-881 meeting the primary endpoint in patients with primary immunodeficiency disease (PID).

The study demonstrated pharmacokinetic comparability between TAK-881 and Hyqvia, an established standard of care. TAK-881, an immune globulin subcutaneous 20% solution combined with recombinant human hyaluronidase, showed similar efficacy, safety, and tolerability profiles.

Importantly, TAK-881 can deliver the required immunoglobulin dose in half the volume of Hyqvia, potentially reducing infusion time while maintaining flexible dosing every three to four weeks. The trial included both adults and children aged two years and above previously treated with immunoglobulin therapy.

No new safety concerns were identified, and infection rates remained comparable between treatments. Takeda plans to present additional data and pursue regulatory submissions in major markets, including the US, EU, and Japan, in 2026.

05-05-2026