Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis

Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor Filing based on unprecedented data package that met all primary endpoints across four Phase 3 studies , including head-to-head superiority comparisons versus deucravacitinib and evaluation of difficult to treat skin sites Submission underscores potential to shift the treatment paradigm for moderate-to-severe plaque psoriasis patients with the standout combination of complete skin clearance, a favorable safety profile, and simplicity of a once daily pill SPRING HOUSE, Pa. , July 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis (PsO).