The U.S. Food and Drug Administration has accepted Takeda Pharmaceutical Company Limited’s new drug application for zasocitinib (also known as TAK-279) for the treatment of moderate-to-severe plaque psoriasis, the company said on September 14, 2026.
The FDA has set a target action date for the application in the first quarter of 2027 under the Prescription Drug User Fee Act.
Zasocitinib is an investigational once-daily oral tyrosine kinase 2 inhibitor. Its efficacy was established across two pivotal Phase 3 trials — LATITUDE PsO 3001, which enrolled 693 participants across 21 countries, and LATITUDE PsO 3002, which enrolled 1,108 participants across 21 countries. A third trial, LATITUDE PsO 3003, was an open-label study evaluating long-term safety and efficacy.
At week 16, approximately 70% of patients overall achieved clear or almost clear skin, measured by static Physician Global Assessment. In LATITUDE PsO 3001, 71% of zasocitinib-treated patients met this endpoint compared with 11% on placebo and 32% on apremilast. In LATITUDE PsO 3002, 69% of treated patients achieved the measure versus 13% on placebo and 30% on apremilast. Zasocitinib also demonstrated efficacy in hard-to-treat areas including the scalp, nails, palms, and soles, with measurements taken at weeks 4, 16, 24, and 52.
In terms of adverse events, upper respiratory tract infection was reported in 10.1% of patients, acne in 6.5%, and nasopharyngitis in 6.2%. The company noted that no new safety signals were identified across the clinical program.
Takeda stated that the NDA filing has no significant impact on its full-year consolidated financial forecast for the fiscal year ending March 31, 2027. The company, headquartered in Osaka, Japan, with operations in Cambridge, Mass., filed the application with both the FDA and the European Medicines Agency.
