J&J wins EC approval for icotrokinra in plaque psoriasis
Johnson & Johnson has received European Commission approval for ICOTYDE (icotrokinra), a once-daily oral peptide that blocks the interleukin-23 receptor, for adults and adolescents aged 12 and over with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. The decision, announced on 21 September 2026, marks the first regulatory authorisation in Europe for an IL-23 receptor antagonist delivered in oral pill form.
Icotrokinra was jointly discovered with Protagonist Therapeutics under a licence and collaboration agreement; J&J holds exclusive worldwide rights for Phase 2 development and beyond. The drug's peptide structure distinguishes it mechanistically from both the injectable biologics that currently dominate the moderate-to-severe psoriasis market and the small-molecule oral option deucravacitinib, which targets TYK2 rather than the IL-23 receptor directly.
Clinical evidence
The EC decision draws on data from the ICONIC Phase 3 programme, which enrolled approximately 2,500 patients across four randomised controlled trials. The programme covered adults and adolescents, including patients with involvement of high-impact sites such as the scalp and genitals, and included two head-to-head studies against deucravacitinib.
In those active-comparator trials, roughly 70% of icotrokinra-treated patients achieved clear or almost clear skin (IGA 0/1) and around 55% reached a PASI 90 response at week 16. The safety profile was notably clean: adverse-event rates among icotrokinra-treated patients were within 1.1 percentage points of placebo through week 16, and no new safety signals emerged through week 52.
Lluís Puig, Professor of Dermatology at the Universitat Autònoma de Barcelona and a paid J&J consultant, said: "The approval of icotrokinra marks an important evolution in plaque psoriasis treatment. As the first targeted oral peptide designed to precisely block the IL-23 receptor, it combines high levels of skin clearance, a favourable safety profile, and the convenience of once-daily oral administration."
Market context and competitive landscape
An estimated 6.4 million people in Europe live with plaque psoriasis, with roughly one quarter having moderate-to-severe disease. The systemic treatment market has historically been dominated by injectable biologics targeting IL-17 and IL-23, including J&J's own Tremfya (guselkumab) and competitors such as Skyrizi (risankizumab, AbbVie) and Cosentyx (secukinumab, Novartis). Oral systemic options have been limited largely to older, less targeted agents such as methotrexate and apremilast, plus the more recently approved deucravacitinib.
An oral therapy that delivers IL-23 pathway precision comparable to injectable biologics could appeal both to patients who prefer to avoid injections and to the substantial population that, according to J&J, is eligible for but not currently receiving systemic treatment. The company is positioning icotrokinra as a first-line systemic option for patients who have cycled through topical therapies without adequate response.
The commercial read-across is significant. The ICONIC programme is also evaluating icotrokinra in psoriatic arthritis, ulcerative colitis and Crohn's disease, suggesting J&J is building a broader immunology platform around the molecule. Positive data in those indications could substantially expand the addressable market, though none of those studies has yet reported results. The drug carries EMA additional-monitoring status, indicated by the inverted triangle symbol, as is standard for newly authorised medicines, meaning healthcare professionals are encouraged to report any suspected adverse reactions promptly.