Tokyo, Japan – December 19, 2025 – Takeda Pharmaceutical Company Limited today announced successful results from two Phase III clinical trials evaluating zasocitinib, an investigational once-daily oral treatment for plaque psoriasis. The therapy was originally identified using artificial intelligence–driven drug discovery technology.
Across both late-stage studies, more than half of treated patients achieved clear or almost clear skin within 16 weeks, demonstrating strong efficacy and a favorable safety profile. Plaque psoriasis is a chronic immune-mediated condition characterized by red, scaly skin lesions and affects millions of patients worldwide.
Based on these results, Takeda plans to submit marketing applications to the U.S. Food and Drug Administration and other global regulatory authorities in 2026.
“Zasocitinib represents a potential new standard for oral psoriasis treatment,” said Andy Plump, President of Research & Development at Takeda. “The combination of efficacy, safety, and once-daily oral convenience is highly compelling and differentiates this therapy in a landscape dominated by injectable treatments.”
If approved, zasocitinib would enter a competitive market that includes established oral therapies and biologic injectables. Industry analysts have noted that the drug’s performance compares favorably with leading oral competitors and could support peak annual sales estimates of $3 billion to $6 billion.
Takeda acquired zasocitinib in 2022 through its strategic agreement with Nimbus Therapeutics, valued at up to $6 billion. The compound was discovered using advanced AI techniques, reflecting a broader shift in pharmaceutical research toward data-driven and computational approaches.
“Artificial intelligence is becoming foundational to how we innovate,” Plump added. “Takeda has ambitions to enable every stage of drug discovery and development with AI, accelerating the delivery of transformative medicines to patients.”
Takeda remains committed to advancing innovative therapies for immune-mediated diseases and improving outcomes for patients worldwide.
About Takeda
Takeda Pharmaceutical Company Limited is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, focused on delivering better health and a brighter future to patients through life-changing treatments.
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