CAMBRIDGE, Mass. — Takeda announced positive topline results from two pivotal Phase 3 studies evaluating zasocitinib, a once-daily oral tyrosine kinase 2 inhibitor, in adults with moderate-to-severe plaque psoriasis.
The randomized, multicenter, double-blind studies met all primary and ranked secondary endpoints, demonstrating superiority over placebo for static Physician Global Assessment 0/1 and Psoriasis Area and Severity Index 75 at week 16. Takeda said a significantly greater PASI 75 response was observed as early as week 4 and continued to increase through week 24.
The trials also met all 44 ranked secondary endpoints, including PASI 90, PASI 100, and sPGA 0 versus both placebo and the active comparator apremilast. More than half of patients treated with zasocitinib achieved clear or almost clear skin, defined as PASI 90, and on average about 30 percent achieved completely clear skin, or PASI 100, by week 16.
Zasocitinib was generally well tolerated, with a safety profile consistent with previous clinical studies. The most common adverse events reported through week 24 were upper respiratory tract infection, nasopharyngitis, and acne. Takeda said no new safety signals were identified.
“People living with psoriasis continue to seek safe, effective and fast-acting oral therapies. These landmark results support zasocitinib’s promise to become a leading oral treatment option that can deliver clear skin for patients with plaque psoriasis,” said Christophe Weber, president and chief executive officer at Takeda. “This marks the third positive Phase 3 readout from our overarching pipeline this year. Each of these programs – zasocitinib, oveporexton and rusfertide – has potential to transform patient lives, redefine medical practice and deliver significant revenue growth in the future.”
Takeda said the Phase 3 results validate earlier findings from Phase 2 studies and highlight the potential of selective TYK2 inhibition as a treatment approach for psoriasis.
“It is incredibly rewarding and exciting to see our Phase 2 results validated in Phase 3, with more than half of patients treated with zasocitinib achieving clear or almost clear skin (PASI 90) and about 30 percent achieving completely clear skin (PASI 100) at week 16, with response rates continuing to increase through week 24,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “These findings help demonstrate that highly selective inhibition of TYK2, a key mediator of IL-23 and other signaling pathways fundamental to psoriasis, may provide patients with significant reductions in their disease burden, including for many, the possibility of complete skin clearance.”
Takeda plans to present the data at upcoming medical congresses and intends to submit a New Drug Application to the U.S. Food and Drug Administration and other regulatory authorities beginning in fiscal year 2026.
Zasocitinib is also being evaluated in a head-to-head study against deucravacitinib in plaque psoriasis, Phase 3 studies in psoriatic arthritis, and Phase 2 studies in Crohn’s disease and ulcerative colitis, among other indications. Takeda said the Phase 3 results do not have a significant impact on its full-year consolidated forecast for the fiscal year ending March 31, 2026.
