Icotrokinra, sold under the brand name Icotyde, is a medication used for the treatment of plaque psoriasis. It is a cyclic peptide that functions as a selective interleukin 23 (IL-23) receptor antagonist. It is being developed by Johnson & Johnson as an oral treatment for autoimmune disorders, including plaque psoriasis and ulcerative colitis. Icotrokinra was approved for medical use in the United States in March 2026.
Medical uses Icotrokinra is indicated for the treatment of moderate-to-severe plaque psoriasis in people aged twelve years of age and older who weigh at least 40 kilograms (88 lb) who are candidates for systemic therapy or phototherapy.
Mechanism of action Icotrokinra is a targeted oral peptide that selectively binds to and blocks the interleukin 23 receptor (IL-23R), thereby inhibiting IL-23-mediated signaling. The drug demonstrates high affinity for the human IL-23 receptor with a dissociation constant (KD) of 7.1 pM and inhibits IL-23-induced STAT3 phosphorylation in peripheral blood mononuclear cells with an IC50 of 5.6 pM. The IL-23 pathway plays a central role in the inflammatory cascade underlying various autoimmune conditions, particularly those involving Th17 cells. Unlike injectable biologics that target IL-23 or its receptor, icotrokinra offers the convenience of oral administration while maintaining selective receptor binding.
Clinical trials
Plaque psoriasis The clinical development program for plaque psoriasis includes several Phase III studies:
ICONIC-LEAD The ICONIC-LEAD study is a Phase III, randomized, double-blind, placebo-controlled trial evaluating icotrokinra versus placebo in patients with moderate to severe plaque psoriasis. The study met its co-primary endpoints, with 74% of patients achieving clear or almost clear skin (IGA 0/1) at week 24.
ICONIC-ADVANCE 1 and 2 The ICONIC-ADVANCE 1 and 2 studies are head-to-head Phase III trials comparing icotrokinra to deucravacitinib (Sotyktu) in patients with moderate to severe plaque psoriasis. Both studies met their co-primary endpoints and demonstrated superiority of icotrokinra over deucravacitinib.
ICONIC-TOTAL The Phase 3 ICONIC-TOTAL study showed once daily icotrokinra met the primary endpoint of IGA of 0/1 at week 16 compared to placebo.
Ulcerative colitis
ANTHEM-UC The ANTHEM-UC study is a Phase IIb trial evaluating icotrokinra in adults with moderately to severely active ulcerative colitis. The study met its primary endpoint of clinical response, with patients treated with the highest dose of icotrokinra achieving a response rate of 63.5% at week 12 versus 27% for placebo.
Safety and tolerability Across clinical studies, icotrokinra has demonstrated a favorable safety profile. In Phase III trials for plaque psoriasis, the most common adverse events were upper respiratory tract infections and headache. Pooled safety data from multiple studies showed similar rates of adverse events between icotrokinra and comparator groups.
History Icotrokinra was jointly discovered by Johnson & Johnson (J&J) and Protagonist Therapeutics.
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