Takeda Pharmaceutical (TAK) said Monday that a pivotal phase 2/3 clinical trial of TAK-881-3001 in primary immunodeficiency disease met its primary endpoint of pharmacokinetic comparability with Hyqvia.

TAK-881 showed comparable infection rates and immune protection to Takeda's Hyqvia, an established treatment, the company said.

The drug also met its secondary endpoints with safety, efficacy, and tolerability profiles comparable to Hyqvia, the company said.

TAK-881 is being evaluated for the potential to deliver the required immunoglobulin dose for PID patients in half the volume of Hyqvia, reducing infusion duration while keeping dosing flexible at every three or four weeks for PID patients, the company said.

Takeda said it expects regulatory filings for TAK-881 in the US, European Union and Japan in fiscal 2026.