Takeda has announced new data from the two pivotal phase-III studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO). Presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting, these data show that convenient once-daily oral zasocitinib demonstrated rapid and durable skin clearance with a safety profile consistent with phase-IIb studies.

“Our goal in psoriasis treatment is clear or almost clear skin, and previously, this has been achieved primarily with injectable therapies. 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,” said Melinda Gooderham, MSc, MD, FRCPC, dermatologist, SKiN Centre for Dermatology, Peterborough, Ontario, Canada, principal investigator for the Latitude PsO studies and presenting author.

In the phase-III randomised, multicentre, double-blind, placebo- and active comparator-controlled Latitude PsO 3001 and 3002 studies, more than half of patients treated with zasocitinib achieved clear or almost clear skin at week 16, a key measure of treatment success.

Zasocitinib also demonstrated statistically significant improvements in complete skin clearance, an increasingly important treatment goal for patients with plaque psoriasis.

In Latitude PsO 3002, rapidity of response was demonstrated as early as week 4 versus placebo (PASI 75: 16.8 percent for zasocitinib vs 4.3 percent for placebo, p<0.001). Among patients who achieved a PASI 75, PASI 90 or sPGA 0/1 response at week 40 and continued on zasocitinib throughout the study, over 90 percent maintained their response at week 60?.

Zasocitinib was generally well-tolerated. The safety and tolerability profile of zasocitinib in the phase-III studies remained consistent with prior studies.

“Our phase-III 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. The positive data also underscore zasocitinib’s potential to deliver rapid and durable results with a favourable safety profile consistent with phase-IIb 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,” said Chinwe Ukomadu, MD, PhD, Senior Vice President and Head, Gastrointestinal and Inflammation Therapeutic Area Unit, Takeda.

Takeda is on track to submit a New Drug Application (NDA) with the US Food and Drug Administration (FDA) and other regulatory authorities starting in fiscal year 2026.