CAMBRIDGE, Mass. — Takeda said new Phase 3 data show its experimental oral drug zasocitinib delivered rapid and sustained skin clearance in patients with moderate-to-severe plaque psoriasis, highlighting its potential as a convenient alternative to injectable therapies.
The results, presented at the 2026 American Academy of Dermatology Annual Meeting, showed that about 70% of patients treated with the once-daily pill achieved clear or almost clear skin at 16 weeks, significantly outperforming placebo and the oral comparator apremilast.
In two late-stage studies, 71.4% and 69.2% of patients receiving zasocitinib reached a static Physician Global Assessment score of 0 or 1, compared with about 11% to 13% for placebo and roughly 30% for apremilast. The drug also demonstrated strong results on more stringent measures, including PASI 90 and complete skin clearance.
Patients receiving zasocitinib showed early improvement, with significantly higher response rates than placebo as soon as four weeks into treatment. The benefits were also durable, with more than 90% of patients who responded by week 40 maintaining their response at week 60.
“Our goal in psoriasis treatment is clear or almost clear skin, and previously this has been achieved primarily with injectable therapies,” said Melinda Gooderham, M.D., dermatologist at the SKiN Centre for Dermatology and principal investigator for the studies. “These efficacy and safety results show it’s possible for a once-daily pill to deliver rapid, lasting skin clearance, highlighting the potential of zasocitinib to become a leading oral treatment option for plaque psoriasis.”
Takeda said the drug, a selective TYK2 inhibitor, was generally well tolerated, with no new safety concerns identified. The most common side effects included upper respiratory tract infections, nasopharyngitis, and acne. Serious adverse events were relatively low and comparable to existing therapies.
“Our Phase 3 results demonstrate that highly selective TYK2 inhibition can offer many people with moderate-to-severe plaque psoriasis the potential for clear or nearly clear skin,” said Chinwe Ukomadu, M.D., Ph.D., senior vice president and head of Takeda’s gastrointestinal and inflammation therapeutic area unit. “The positive data also underscore zasocitinib’s potential to deliver rapid and durable results with a favorable safety profile consistent with Phase 2b studies. We are working as quickly as possible with regulators to advance a potential new therapeutic option for patients seeking a safe, effective and convenient oral treatment.”
Takeda said it plans to begin regulatory submissions for zasocitinib with the U.S. Food and Drug Administration and other agencies starting in fiscal year 2026.
