FDA Grants Priority Review to Zasocitinib for Plaque Psoriasis

The US Food and Drug Administration (FDA) has accepted Takeda’s new drug application (NDA) for zasocitinib (TAK-279) for adults with moderate-to-severe plaque psoriasis and granted the application Priority Review, according to a company announcement.

Zasocitinib is an investigational, once-daily oral tyrosine kinase 2 (TYK2) inhibitor. The FDA has set a Prescription Drug User Fee Act target action date in the first quarter of 2027.

Phase 3 Zasocitinib Data in Plaque Psoriasis

The NDA was underpinned by data from the multicenter, randomized, double-blind, placebo- and active comparator-controlled Phase 3 LATITUDE PsO 3001 and LATITUDE PsO 3002 trials in adults with moderate-to-severe plaque psoriasis. The NDA also includes data from LATITUDE PsO 3003, an open-label study evaluating long-term safety, tolerability, and efficacy.

At week 16, 71% of zasocitinib-treated patients in LATITUDE PsO 3001 achieved a static Physician Global Assessment (sPGA) score of 0 or 1 compared with 11% receiving placebo and 32% receiving apremilast (P < 0.001). Corresponding rates in LATITUDE PsO 3002 were 69%, 13%, and 30%, respectively (P < 0.001).

PASI 75 responses at week 16 were 76% with zasocitinib versus 12% with placebo and 37% with apremilast in LATITUDE PsO 3001 and 71% versus 12% and 33%, respectively, in LATITUDE PsO 3002 (P < .001). Responses were also reported across scalp, nail, palm, and sole involvement.

Takeda reported that zasocitinib was generally well tolerated, with no new safety signals identified. The most common adverse events across the 2 pivotal studies included upper respiratory tract infection, acne, and nasopharyngitis.

The European Medicines Agency has also accepted Takeda’s marketing authorization application for zasocitinib. The drug remains investigational pending regulatory review.

Source

Takeda press release. September 14, 2026.