Takeda Announces Positive Topline Results from Pivotal Phase 2/3 Clinical Trial of TAK-881 in Primary Immunodeficiency Disease (PID)

OSAKA, Japan and CAMBRIDGE, Massachusetts, May 4, 2026 – Takeda (TSE:4502/NYSE:TAK) today announced that 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).

Investigational TAK-881 was comparable to established HYQVIA while also demonstrating reduced infusion volume and duration for PID patients

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.

About TAK-881-3001 and TAK-881-3002

TAK-881-3001 was a pivotal Phase 2/3 clinical trial evaluating the pharmacokinetics, efficacy, safety, tolerability and immunogenicity of TAK-881 in adults and pediatric patients aged 2 years and older with Primary Immunodeficiency Disease (PID) who were previously treated with immunoglobulin (IG). Study participants aged 16 and older were randomized to be treated with TAK-881 followed by HYQVIA or HYQVIA followed by TAK-881 with the same dose and dosing interval of IG for up to 51 weeks in the open label, randomized cross-over study part. Participants aged 2 to < 16 were treated with only TAK-881 for up to 27 weeks in the open label single-arm study part. Further information about the TAK-881-3001 clinical trial is available at ClinicalTrials.gov under study identifier NCT05755035.

TAK-881-3002 is a Phase 3 study evaluating the long-term safety and tolerability of TAK-881 in patients with PID and is the extension study of TAK-881-3001. Further information about the TAK-881-3002 clinical trial is available at ClinicalTrials.gov under study identifier NCT06076642.

About TAK-881

TAK-881 [Immune Globulin Subcutaneous (Human), 20% Solution (SCIG 20%) and Recombinant Human Hyaluronidase] is an investigational liquid medicine comprised of one vial of immunoglobulin (IG) 20% and one vial of Halozyme’s recombinant human hyaluronidase (rHuPH20). IG is collected from human plasma and maintains the body’s immune system. TAK-881 is infused under the skin into the fatty subcutaneous tissue where the hyaluronidase facilitates the dispersion and increases the absorption of immunoglobulin in the subcutaneous tissue, allowing larger volumes to be infused at a given infusion site. As a SCIG 20% facilitated with hyaluronidase, TAK-881 is being developed with the goal of reducing infusion volume and duration while providing effective immune protection for patients with PID.

About Primary Immunodeficiency Disease (PID)

Primary Immunodeficiency Disease (PID) is a group of more than 550 rare and chronic disorders, where a part of the body’s immune system is missing or does not function the way it should.1 These conditions result from genetic mutations, which are usually inherited.2 The symptoms of PID vary and can include frequent and/or persistent infections and unusual autoimmunity, often leading to prolonged periods of misdiagnosis despite consultations with multiple specialists.3 In the United States, PID affects about 1 in 1,200 people.4

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

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References

Immune Deficiency Foundation. Living With Primary Immunodeficiency. Accessed April 2026. Available at: https://primaryimmune.org/living-primary-immunodeficiency.

Center for Disease Control and Prevention. About Primary Immunodeficiency (PI). Accessed April 2026. Available at: https://www.cdc.gov/primary-immunodeficiency/about/index.html.

Immune Deficiency Foundation. Understanding Primary Immunodeficiency. Accessed April 2026. Available at: https://primaryimmune.org/understanding-primary-immunodeficiency.

Kobrynski L, Powell RW, Bowen S. J Clin Immunol. 2014;34(8):954-961

Source: Takeda

Source: HealthDay

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Posted : 2026-05-05 09:26

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