The U.S. Food and Drug Administration (FDA) accepted Takeda’s New Drug Application (NDA) for zasocitinib (TAK-279). The agency granted Priority Review for the treatment of moderate-to-severe plaque psoriasis in adults. This designation shortens the review timeline for drugs that offer significant improvements in safety or effectiveness for serious conditions.
A Phase 3 clinical program involving nearly 3,000 patients supports the application. The once-daily oral TYK2 inhibitor demonstrated rapid, durable, and consistent skin clearance. The studies met all primary and ranked secondary endpoints. Data showed statistically significant improvements across multiple measures, including high-impact areas like the scalp and nails.
The FDA set a Prescription Drug User Fee Act (PDUFA) target action date for the first quarter of 2027. Zasocitinib could redefine oral treatment expectations within the competitive psoriasis market. This regulatory milestone marks a key advancement for Takeda’s drug pipeline.