Takeda Pharmaceutical Company Limited (NYSE: TAK) announced results from two Phase 3 studies of zasocitinib, an oral tyrosine kinase 2 inhibitor, for moderate-to-severe plaque psoriasis treatment.

In the Latitude PsO 3001 and 3002 studies, 71.4% and 69.2% of patients treated with zasocitinib achieved clear or almost clear skin at week 16, compared to 10.7% and 12.6% for placebo and 32.1% and 29.7% for apremilast. The studies enrolled 693 and 1,108 participants respectively across 21 countries.

Complete skin clearance was achieved by 39.9% and 33.7% of zasocitinib patients versus 0.7% and 1.4% for placebo and 8.0% and 6.5% for apremilast at week 16. Significant improvements versus placebo were observed as early as week 4 in one study.

Treatment-emergent adverse events through week 16 occurred in 62.1% of zasocitinib patients, 46.9% for placebo and 50.5% for apremilast. The most common adverse events for zasocitinib were upper respiratory tract infection (10.1%), nasopharyngitis (6.2%) and acne (6.5%). Serious adverse events occurred in 3.0% of zasocitinib patients.

Among patients achieving response at week 40 who continued zasocitinib treatment, over 90% maintained their response at week 60.

Takeda plans to submit a New Drug Application with the U.S. Food and Drug Administration and other regulatory authorities starting in fiscal year 2026. The company stated the results have no significant impact on its full-year consolidated forecast for the fiscal year ending March 31, 2026.

The data was presented at the American Academy of Dermatology Annual Meeting. Zasocitinib is an investigational compound that has not been approved by any regulatory authority.