for moderate-to-severe plaque psoriasis (adults and adolescents ≥12 yrs, ≥40 kg)
FDA approved Icotyde (icotrokinra) on March 18, 2026 — ahead of the Jul 21 2026 PDUFA target. First and only targeted oral peptide IL-23 receptor antagonist; first-line systemic therapy for moderate-to-severe plaque psoriasis. Adolescent inclusion (≥12 yrs, ≥40 kg) distinguishes it from injectable comparators.
Psoriasis is a long-lasting, noncontagious autoimmune disease in which the immune system attacks the skin, causing red, itchy, scaly patches that can range from small spots to coverage of the whole body. Icotyde is a pill containing icotrokinra, a short protein that blocks the IL-23 receptor, a docking site that immune cells use to keep inflammation switched on. Shutting off that signal may calm the overactive immune response in the skin, potentially clearing plaques and reducing itching for adults and adolescents with moderate-to-severe disease.
The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Source: ClinicalTrials.gov