FDA Accepts Takeda's Zasocitinib NDA for Plaque Psoriasis

The U.S. Food and Drug Administration has accepted Takeda's New Drug Application under Priority Review for zasocitinib, positioning the oral therapy for a targeted decision date in the first quarter of calendar year 2027.

"Despite progress in psoriasis care, there remains a need for highly effective oral therapies that also address the diverse and often challenging manifestations of psoriasis, including involvement of high-impact sites like the scalp," said Andy Plump, M.D., Ph.D., president of R&D at Takeda.

Mechanism and Phase 3 Clinical Trial Data

Zasocitinib, also known as TAK-279, is an investigational, oral tyrosine kinase 2 inhibitor designed to be taken once daily. According to Takeda's announcement, the New Drug Application filing is backed by data from pivotal global Phase 3 trials, including LATITUDE PsO 3001 and LATITUDE PsO 3002, alongside the open-label safety study LATITUDE PsO 3003.

In these pivotal studies, approximately 70% of patients achieved clear or almost clear skin, measured as an investigator global assessment score of 0 or 1, at week 16. The priority review designation shortens the standard regulatory review clock, reflecting the agency's recognition of the drug's potential to offer improvements in safety or efficacy over existing options.

Regulatory Milestones and Financial Outlook

Alongside the U.S. submission, the European Medicines Agency also accepted Takeda's new marketing authorization application for zasocitinib, setting up parallel regulatory reviews across major pharmaceutical markets.

Takeda reported that the New Drug Application filing carries no significant impact on its full-year consolidated financial forecast for the fiscal year ending March 31, 2027.