Takeda Pharmaceutical Co. Ltd. (TAK) Thursday reported that its Phase 3 studies of once-daily oral Zasocitinib met all primary and ranked secondary endpoints in adults with moderate-to-severe plaque psoriasis.
Plaque psoriasis, the most common form of psoriasis, is a chronic immune-mediated disease characterized by red, scaly patches that cause itching and pain. Globally, about 64 million people live with psoriasis, with plaque psoriasis accounting for up to 90% of cases.
Zasocitinib or TAK-279 is a next-generation, highly selective oral tyrosine kinase 2 inhibitor designed to maintain 24-hour inhibition of IL-23 and other immune pathways fundamental to psoriasis.
According to Takeda, more than half of patients treated with Zasocitinib achieved clear or almost clear skin under Psoriasis Area and Severity Index or PASI 90, while about 30% reached complete clearance of PASI 100, by week 16. Superiority over placebo was demonstrated as early as week 4, with responses continuing to improve through week 24. The drug was generally well-tolerated, with a safety profile consistent with earlier trials.
The LATITUDE Phase 3 program comprised two global, randomized, double-blind, placebo- and active comparator-controlled studies enrolling over 1,800 participants across 21 countries.
•NCT06088043- enrolled 692 participants. Zasocitinib met co-primary enpoints of sPGA 0/1 and PASI 75 at week 16, with secondary endpoints including PASI 90 and PASI 100.
•NCT06108544- enrolled 1,108 participants. Results similarly showed superiority versus placebo and apremilast, with more than half of patients achieving PASI 90 and about 30% reaching PASI 100 by week 16. Responses continued to improve through week 24.
Across both studies, all co-primary or sPGA 0/1 and PASI 75, and all 44 ranked secondary endpoints were also met, including comparisons versus placebo and apremilast.
Takeda highlighted the drug's more than 1-million-fold greater selectivity for Tyrosine Kinase 2 over other Janus kinase enzymes, potentially minimizing off-target effects.
Takeda plans to present full results at upcoming medical congresses and submit a New Drug Application to the U.S. FDA and other regulators beginning in fiscal year 2026.
The company is also advancing Zasocitinib in Phase 3 studies for psoriatic arthritis and Phase 2 trials in Crohn's disease, ulcerative colitis and vitiligo.
Takeda emphasized that this marks its third positive Phase 3 readout in 2025, alongside Oveporexton and Rusfertide, underscoring the company's pipeline momentum and potential for significant revenue growth.
TAK has traded between $12.80 and $15.69 over the past year. The stock closed yesterday's trading at $14.47, down 0.41%, and rose in the pre-market trading at $14.64, up 1.17%.
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