- FDA approved ICOTYDE (icotrokinra) on March 18, 2026 for adults and pediatric patients ≥12 years old who weigh ≥40 kg with moderate‑to‑severe plaque psoriasis.
- ICOTYDE is a 200 mg once‑daily targeted oral peptide that antagonizes the IL‑23 receptor and is taken upon waking, 30 minutes before food.
- Approval relied on the ICONIC Phase 3 program (~2,500 patients across four pivotal trials) reporting ~70% IGA 0/1 and 55% PASI90 at Week 16 versus active comparator, with adverse reaction rates within 1.1% of placebo through Week 16 and no new safety signals through Week 52; the therapy was co‑discovered with Protagonist under a Johnson & Johnson license and collaboration.
Approval and indication
FDA approved ICOTYDE (icotrokinra) on March 18, 2026 for adults and pediatric patients ≥12 years old who weigh ≥40 kg with moderate‑to‑severe plaque psoriasis who are candidates for systemic therapy or phototherapy; it is described as a targeted oral peptide that blocks the IL‑23 receptor.
Clinical evidence
Approval was supported by the ICONIC Phase 3 program (four pivotal studies, ~2,500 patients) that evaluated adults and adolescents and included special‑site assessments and duplicate head‑to‑head trials versus active comparators; in head‑to‑head studies ≈70% achieved IGA 0/1 and 55% achieved PASI90 at Week 16.
Dosing and administration
Labelled dose is 200 mg once daily taken with water upon waking, at least 30 minutes before food; tablets can be dispersed in water and if a dose is missed it should be taken as soon as remembered.
Safety and precautions
Immunomodulation can increase infection risk; patients should be evaluated for active or latent TB before and monitored during treatment; avoid live vaccines during therapy; pregnancy and lactation data are limited and a pregnancy registry is available; most common adverse events include headache, nausea, cough, fungal infection and fatigue; adverse reaction rates were within 1.1% of placebo through Week 16 and no new safety signals were reported through Week 52.
Development and pipeline
ICOTYDE was co‑discovered with Protagonist under a licence agreement and is being studied in additional indications including psoriatic arthritis, moderately‑to‑severely active ulcerative colitis and Crohn’s disease.
