Takeda Zasocitinib Gets FDA Priority Review for Psoriasis

Osaka, Japan & Cambridge, Massachusetts, U.S., September 14, 2026

Phase 3 Data Support FDA Application

The NDA is supported principally by the global, randomized, double-blind, placebo- and active-comparator-controlled LATITUDE PsO 3001 and LATITUDE PsO 3002 Phase 3 trials. The studies evaluated zasocitinib in adults with moderate-to-severe plaque psoriasis and met their co-primary and ranked secondary endpoints. At Week 16, approximately 70% of patients receiving zasocitinib achieved clear or almost clear skin, measured by a static Physician Global Assessment (sPGA) score of 0/1. In the two studies, sPGA 0/1 responses were 71.4% and 69.2% with zasocitinib, compared with 10.7% and 12.6% with placebo and 32.1% and 29.7% with apremilast. The treatment also produced strong PASI 75 and PASI 90 responses, with improvements emerging rapidly and continuing through later assessments. The clinical program has also generated evidence across hard-to-treat and high-impact psoriasis sites, including the scalp, nails, palms and soles. Takeda reported that approximately 75% of patients with scalp psoriasis achieved clear or almost clear skin at Week 16, while approximately 70% of patients with palmoplantar disease achieved similar clearance. These findings are particularly relevant because psoriasis affecting the scalp, hands, feet and nails can be difficult to manage and may substantially affect patients’ quality of life. The Phase 3 program also demonstrated improvements in complete skin clearance, with PASI 100 responses reaching 33.4% and 25.2% in the two pivotal studies at Week 16.

Investigational TYK2 Inhibitor Advances Toward Review

Zasocitinib is being developed as a selective TYK2 inhibitor that targets inflammatory pathways involved in psoriasis while avoiding inhibition of JAK1, JAK2 and JAK3. In the Phase 3 studies, skin clearance was observed as early as Week 4, with responses increasing through Week 24 and continuing to demonstrate durability during longer follow-up. Takeda reported that the therapy was generally well tolerated, with a safety profile consistent with previous clinical studies and no new safety signals identified. Frequently reported adverse events included upper respiratory tract infection, nasopharyngitis and acne. The NDA also incorporates supportive information from LATITUDE PsO 3003, an open-label Phase 3 study evaluating longer-term safety, tolerability and efficacy. The FDA’s Priority Review designation does not represent approval of zasocitinib, and the therapy remains investigational in the United States. If approved, zasocitinib could provide an additional oral treatment option for adults with moderate-to-severe plaque psoriasis, potentially addressing demand for effective therapies that combine systemic disease control with the convenience of once-daily oral administration. Takeda has also reported that the European Medicines Agency (EMA) has accepted its marketing authorization application for zasocitinib, initiating a separate regulatory review. Beyond plaque psoriasis, the compound is being investigated in additional inflammatory diseases, including psoriatic arthritis, Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa.

Source: Takeda press release