TAK-881-3001, a pivotal Phase 2/3 clinical trial in patients with Primary Immunodeficiency Disease (PID), met its primary endpoint, which demonstrated pharmacokinetic (PK) comparability between the investigational TAK-881 [Immune Globulin Subcutaneous (Human), 20% Solution (SCIG 20%) with Recombinant Human Hyaluronidase] and HYQVIA [Immune Globulin Infusion (Human) 10% with Recombinant Human Hyaluronidase]. Additionally, secondary endpoints showed that TAK-881, a SCIG 20% facilitated with hyaluronidase, demonstrated safety, efficacy and tolerability profiles comparable to HYQVIA, an established SCIG 10% facilitated with hyaluronidase. These findings support the potential of TAK-881 to deliver the required immunoglobulin (IG) dose for PID patients in half the volume of HYQVIA, reducing infusion duration while maintaining flexible, up to once-monthly dosing for patients (every three or four weeks for PID).

The TAK-881-3001 clinical trial evaluated the PK, efficacy, safety, tolerability and immunogenicity of TAK-881 in adults and pediatric patients aged 2 years and older with PID previously treated with IG therapy and compared them with HYQVIA in patients aged 16 years and older. Initial topline data show TAK-881:

Achieved comparable PK: The study met its primary endpoint demonstrating equivalent immunoglobulin G (IgG) exposure between TAK-881 and HYQVIA as shown by a geometric mean ratio of 99.67% (90% CI: 95.10% to 104.46%) for the areas under the concentration-time profiles over one dosing interval at the steady state (AUC0-tau,ss).
Provided immune protection: TAK‑881 demonstrated comparable infection rates and immune protection to HYQVIA, with protective IgG levels consistently maintained throughout the study.
Demonstrated a comparable safety profile: The safety and tolerability profiles of TAK-881 shown were comparable to HYQVIA, with no new safety signals observed. The safety profile of TAK-881 will continue to be evaluated in the ongoing TAK-881-3002 extension study.
"These Phase 2/3 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," said Kristina Allikmets, MD, PhD, Senior Vice President and Head of Plasma Derived Therapies R&D at Takeda. "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."

For many patients with PID, IG replacement is the only treatment option to maintain immune protection against infections. While existing IG therapies are effective, many patients continue to experience treatment burden, including frequent or high-volume infusions.

"Patients needing lifelong IG therapy for PID experience a significant burden of care. Improving the administration process can diminish the burden of care by substantively impacting the treatment experience," said Richard L. Wasserman, MD, PhD, allergist/immunologist and principal investigator for TAK-881-3001. "These topline results from TAK-881-3001 are encouraging. They show that a highly concentrated, hyaluronidase-facilitated subcutaneous IG can provide immune protection with a more manageable infusion experience intended to enhance the day-to-day lives of patients living with PID."

Analyses from TAK-881-3001 are ongoing, and Takeda anticipates sharing additional results in an upcoming medical forum. Takeda expects to submit applications for TAK-881 to regulatory authorities in the United States, European Union and Japan in fiscal year 2026.