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.
Plaque psoriasis is a long-lasting autoimmune disease that causes patches of skin to become red, dry, itchy, and scaly. Icotyde is an oral peptide that blocks the IL-23 receptor, a key driver of the inflammatory process in the skin. By targeting this pathway at its source, the treatment could offer a convenient way to calm the overactive immune response and clear the skin lesions.
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