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News
Zasocitinib, Takeda's once-daily oral TYK2 inhibitor, has received FDA Priority Review for moderate-to-severe plaque psoriasis, with a decision expected in Q1 2027. In two large phase 3 trials, it significantly outperformed both apremilast and placebo — and head-to-head data show it also bests deucravacitinib, the only currently approved TYK2 inhibitor for psoriasis.
The FDA has accepted Takeda's new drug application for zasocitinib — an oral, once-daily TYK2 inhibitor — under Priority Review for the treatment of moderate-to-severe plaque psoriasis in adults. A regulatory decision is expected in Q1 2027. The filing was backed by results from two large phase 3 trials (LATITUDE PsO 3001 and 3002) conducted across 21 countries, in which zasocitinib hit all primary and secondary endpoints.
Beyond beating placebo, zasocitinib significantly outperformed apremilast (Otezla) — a commonly used oral therapy — and also bested deucravacitinib (Sotyktu), the only currently approved TYK2 inhibitor for psoriasis, achieving complete skin clearance at more than 2.5 times the rate. It also showed strong results in notoriously hard-to-treat areas like the scalp, nails, and palms and soles. The drug was generally well tolerated, with no new safety signals identified.
By the Numbers:
35% achieved PASI 100 vs. deucravacitinib in the head-to-head LATITUDE Atlas trial
Why it matters: If approved, zasocitinib could become a compelling oral option for psoriasis patients who need more than what current therapies offer — particularly those with difficult-to-treat sites — without the cardiovascular and blood disorder risks associated with broader JAK inhibitors.
