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 chronic autoimmune disease that causes raised, inflamed patches of skin that become dry, itchy, and scaly, sometimes covering large areas of the body. Icotyde (icotrokinra) is an oral peptide that blocks the IL-23 receptor, a key immune signal that drives skin inflammation. By interrupting this pathway, the drug may reduce the overactive immune response responsible for psoriasis flare-ups and improve skin symptoms.
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