U.S. FDA Accepts New Drug Application Under Priority Review for Takeda’s Zasocitinib in Moderate-to-Severe Plaque Psoriasis

On September 14, 2026, the U.S. Food and Drug Administration (FDA) accepted a new drug application for Takeda’s Zasocitinib under priority review for the treatment of moderate-to-severe plaque psoriasis. The application was submitted by Takeda, a Japanese pharmaceutical company. The FDA’s priority review designation indicates the agency expects to make a decision on the application within six months. Zasocitinib is an oral medication that targets specific pathways involved in psoriasis. The drug has the potential to redefine oral treatment expectations for patients with moderate-to-severe plaque psoriasis, according to the sources. The FDA’s acceptance of the application marks a significant step toward potential approval and market availability. Both news outlets, la-prensa-273 and tt-news-agency, reported the same headline and details, with no divergence in the information provided.