FDA Approves Icotyde (icotrokinra) for the Treatment of Moderate-To-Severe Plaque Psoriasis in Adults and Pediatric Patients
On March 18, 2026, the US Food and Drug Administration (FDA) approved Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy. Icotrokinra is an oral, targeted interleukin-23 (IL-23) receptor antagonist and is the first oral peptide designed to selectively block the IL-23 pathway.
The approval is based on results from the phase 3 ICONIC clinical development program, which included multiple randomized, double-blind trials evaluating efficacy and safety in more than 2500 patients. Co-primary endpoints included achievement of Investigator’s Global Assessment (IGA) 0/1 and Psoriasis Area and Severity Index (PASI) 90 responses. In head-to-head superiority studies, approximately 70% of patients achieved clear or almost clear skin (IGA 0/1), and 55% achieved PASI 90 at week 16.
“Icotyde delivers something unique in psoriasis treatment—combining skin clearance with a favorable safety profile in a once-daily pill,” said Linda Stein Gold, MD. She noted that this oral option may align with evolving guidance to transition patients to systemic therapy when topical treatments fail to provide meaningful improvement.
The safety profile was favorable and comparable to placebo in early treatment. Rates of adverse events were within 1.1% of placebo through week 16, with no new safety signals identified through week 52. The most common adverse events included headache, fungal infections, nausea, fatigue, and cough. Warnings include risk of infections, including tuberculosis, and avoidance of live vaccines during treatment.
Icotrokinra targets IL-23 receptor signaling, a key driver of psoriatic inflammation. By binding selectively to the receptor, the therapy modulates downstream immune pathways involved in keratinocyte activation and cytokine signaling.
Reference
FDA approval of ICOTYDE (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide. News release. March 18, 2026. Accessed March 18, 2026. https://www.multivu.com/johnson-johnson/9378651-en-icotyde-icotrokinra-fda-approval-first-line-systemic-treatment-plaque-psoriasis
