TAK-881

October 14, 2026: Takeda (TAK) reported detailed pivotal Phase 2/3 IgGNITE (TAK-881-3001) results for investigational TAK-881 in primary immunodeficiency disease (PID), with data in patients aged 16 years and older presented in two late-breaking posters at ESID 2026.

TAK-881 met the primary endpoint, showing pharmacokinetic comparability to HYQVIA. IgG trough concentrations were 11.7 vs. 11.9 g/L. The same bodyweight-adjusted IG dose was delivered in 50% less volume, with shorter median infusion times versus HYQVIA: 75.8 vs. 132 minutes with one infusion site and 58.3 vs. 86 minutes with two infusion sites, at a median maximum tolerated rate of 300 mL/hour/site.

Descriptive analyses showed comparable infection protection: annualized infection rates were 2.62 (95% CI 1.75–3.76) for TAK-881 vs. 2.73 (1.85–3.86) for HYQVIA; annualized serious bacterial infection rate was 0.0558 (0.0197–0.121). TAK-881 was well tolerated, with TEAEs in 56.1% (23/41) vs. 50.0% (19/38) on HYQVIA, no new safety signals, no TAK-881-related serious adverse events, and no TAK-881-related discontinuations. Long-term safety is being evaluated in the Phase 3 extension study TAK-881-3002. Takeda expects regulatory submissions in the U.S., EU, and Japan in fiscal 2026.