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FDA approves oral IL-23R peptide ICOTYDE for eligible patients with plaque psoriasis

Company / institutional announcement · Johnson & Johnson

Source published: 2026-03-18 · Event / reporting date: 2026-03-17

Site published: 2026-11-03 · Updated: 2026-11-03

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Findings and limitations Industry implications Related developments

What changed

FDA approved icotrokinra, marketed as ICOTYDE, on March 17; Johnson & Johnson announced the decision the following day. The once-daily oral IL-23 receptor antagonist is indicated for eligible adults and patients aged 12 or older weighing at least 40 kg with moderate-to-severe plaque psoriasis. The approval does not extend to ulcerative colitis or other investigational indications.

Why it may matter

Marks regulatory validation for a targeted oral peptide while requiring careful attention to indication, age, and weight restrictions.

The interpretation above is analysis, not a conclusion attributed to the original source.

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2026-11-07Johnson & Johnson (PR Newswire)

Icotrokinra meets Phase 3 joint-response endpoint in biologic-naive psoriatic arthritis

Johnson & Johnson reported that 58% of patients receiving icotrokinra 200 mg achieved ACR20 at Week 16 in ICONIC-PsA 1, versus 41% with placebo. The oral IL-23 receptor peptide also showed skin responses. The company reported no new safety signals through Week 24; active psoriatic arthritis remains an investigational indication.

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2026-11-06Johnson & Johnson

ICONIC-ASCEND reports icotrokinra noninferiority to ustekinumab in plaque psoriasis

Johnson & Johnson reported that ICONIC-ASCEND met its Week 16 co-primary endpoints: PASI 90 responses were 55.2% with icotrokinra versus 3.6% with placebo, and IGA 0/1 responses were 70.4% versus 9.5%. At Week 28, the oral peptide met noninferiority criteria versus ustekinumab across multiplicity-controlled key secondary skin-clearance endpoints.

Companies mentionedJohnson & Johnson ↗

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