TAK-881 — NDA/BLA submission
2026
Takeda expects to submit applications for TAK-881 to regulatory authorities in the United States, European Union and Japan in fiscal year 2026.Source filing
TAK biotech catalysts & pipeline
TAKEDA PHARMACEUTICAL CO LTD · Data as of 2026-10-25
Upcoming catalysts
zasocitinib — NDA/BLA submission
FY2026
We completed regulatory filings for oveporexton in the U.S., Japan and China, and for rusfertide in the U.S.; zasocitinib will be filed in FY2026.Source filing
zasocitinib — PDUFA
Q1 2027
The Prescription Drug User Fee Act (PDUFA) target action date is in the first quarter of calendar year 2027Source filing
zasocitinib — Regulatory decision
Q1 2027
Zasocitinib is currently under FDA Priority Review, with a decision anticipated in the first quarter of 2027.Source filing