Takeda Pharmaceutical Company has announced positive topline results from two pivotal Phase 3 clinical trials evaluating zasocitinib (TAK-279), a next-generation oral therapy for adults with moderate-to-severe plaque psoriasis. The findings strengthen the company’s position in the competitive psoriasis treatment landscape and highlight the potential of a once-daily pill to deliver high levels of skin clearance for patients.
The randomized, multicenter, double-blind studies compared zasocitinib with placebo and the active comparator apremilast. Both trials met their co-primary endpoints at week 16, demonstrating clear superiority over placebo on the static Physician Global Assessment (sPGA) 0/1 and the Psoriasis Area and Severity Index (PASI) 75. Notably, patients treated with zasocitinib showed significant improvement as early as week 4, with response rates continuing to rise through week 24.
Beyond the primary measures, the studies achieved all 44 ranked secondary endpoints. These included higher thresholds of skin clearance such as PASI 90, PASI 100 and sPGA 0, compared not only with placebo but also with apremilast. The results suggest that zasocitinib may offer a convenient oral alternative capable of delivering outcomes traditionally associated with injectable biologic therapies.
Christophe Weber, president and chief executive officer of Takeda, said the results underscore the growing demand for effective and fast-acting oral treatments for psoriasis. He noted that these findings represent the company’s third positive Phase 3 readout this year, alongside other pipeline assets such as oveporexton and rusfertide. According to Weber, these programs have the potential to transform patient care while also supporting long-term growth for the company.
From a safety perspective, zasocitinib was generally well tolerated. The safety profile observed through week 24 was consistent with earlier studies, including Phase 2b trials. The most common adverse events were upper respiratory tract infection, nasopharyngitis and acne, and no new safety concerns were identified. Takeda’s research leadership highlighted that more than half of treated patients achieved clear or almost clear skin by week 16, with approximately 30 percent reaching complete skin clearance, and that outcomes continued to improve over time.
Andy Plump, Takeda’s president of research and development, emphasized the importance of selectively targeting tyrosine kinase 2 (TYK2), a key mediator in inflammatory pathways central to psoriasis. He said the Phase 3 results validate earlier data and demonstrate the potential for meaningful reductions in disease burden, including complete skin clearance for many patients.
Takeda plans to present the full data set at upcoming medical congresses and intends to begin regulatory submissions with the U.S. Food and Drug Administration and other authorities starting in fiscal year 2026. In parallel, zasocitinib is being studied in additional indications, including a head-to-head trial against deucravacitinib in plaque psoriasis, Phase 3 trials in psoriatic arthritis, and Phase 2 studies in Crohn’s disease and ulcerative colitis. The company said the results do not materially impact its consolidated financial forecast for the fiscal year ending March 31, 2026.