Icotrokinra: First Approval

Icotrokinra (ICOTYDE™) is a targeted oral peptide interleukin (IL)-23 receptor (IL-23R) antagonist being developed by Johnson & Johnson, and Protagonist Therapeutics, Inc., for the treatment of immune-mediated inflammatory diseases. In March 2026, the US FDA approved icotrokinra for the treatment of moderate-to-severe plaque psoriasis (PsO) in adults and paediatric patients ≥ 12 years of age and who weigh ≥ 40 kg who are candidates for systemic therapy or phototherapy. Icotrokinra is also under review for this indication in the EU and in Canada. This article summarizes the milestones in the development of icotrokinra leading to this first approval for moderate-to-severe plaque PsO.