Beerse, Belgium, September 21, 2026
Johnson & Johnson has reached a major European regulatory milestone with the European Commission’s approval of ICOTYDE™ (icotrokinra) for the treatment of adults and adolescents aged 12 years and older who weigh at least 40 kg and have moderate-to-severe plaque psoriasis and are candidates for systemic therapy. Icotrokinra is a targeted oral peptide designed to selectively block the interleukin-23 receptor (IL-23R), an important component of the inflammatory pathway involved in psoriasis. The approval makes ICOTYDE the first targeted oral peptide designed to directly block the IL-23 receptor, offering a once-daily oral treatment option for eligible patients. The European Commission decision follows evidence from the Phase 3 ICONIC clinical development programme, which evaluated icotrokinra across multiple patient populations and disease manifestations.
ICOTYDE Targets IL-23 Receptor With Oral Peptide
Icotrokinra, also known as JNJ-77242113 or JNJ-2113, is an oral peptide that binds to the IL-23 receptor and selectively inhibits IL-23 signaling. Johnson & Johnson developed the medicine as a targeted approach to immunodermatology, with the goal of addressing inflammation associated with moderate-to-severe plaque psoriasis through once-daily oral administration. Under the approved European dosing instructions, patients take one tablet each day with water upon waking, at least 30 minutes before eating. The company said the treatment provides an alternative for patients who require systemic therapy while offering an oral administration route.
The European approval was supported by data from four Phase 3 studies involving approximately 2,500 patients. According to Johnson & Johnson, icotrokinra met all primary efficacy endpoints across the Phase 3 programme and demonstrated a favourable safety profile. The ICONIC programme included studies involving patients with plaque psoriasis affecting high-impact areas, including the scalp and genital region, as well as head-to-head evaluations against an active comparator. In the head-to-head studies, approximately 70% of patients achieved clear or almost clear skin, measured by an Investigator Global Assessment score of 0 or 1, while 55% achieved a PASI 90 response at Week 16.
Phase 3 ICONIC Data Support European Approval
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The ICONIC clinical programme includes several randomized Phase 3 studies evaluating the efficacy and safety of icotrokinra against placebo and, in some trials, established active treatments. ICONIC-LEAD evaluated patients aged 12 years and older with moderate-to-severe plaque psoriasis, while ICONIC-TOTAL focused on disease involving high-impact areas such as the scalp, genital region, hands and feet. ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 evaluated icotrokinra against placebo and deucravacitinib, providing comparative clinical data for the targeted oral peptide.
Safety findings also contributed to the European regulatory decision. Johnson & Johnson reported that the rate of adverse reactions among icotrokinra-treated patients was within 1.1 percentage points of placebo rates through Week 16, with no new safety signals identified through Week 52 in the cited clinical programme. Because ICOTYDE is a newly authorized medicine, it is subject to additional monitoring under European regulations, allowing safety information to continue to be collected following approval.
Johnson & Johnson Expands Icotrokinra Development
The approval for plaque psoriasis represents an important regulatory milestone within Johnson & Johnson’s broader development programme for icotrokinra. Clinical studies are also investigating the IL-23 receptor-targeting peptide in active psoriatic arthritis, ulcerative colitis and Crohn’s disease. These programmes are evaluating whether selective oral IL-23 receptor inhibition could have applications across additional immune-mediated inflammatory diseases. Plaque psoriasis affects millions of people worldwide and can involve visible or sensitive areas of the body, potentially affecting quality of life. The European Commission authorization provides eligible patients with a new once-daily targeted oral treatment option for moderate-to-severe disease. With ICOTYDE now approved in Europe, Johnson & Johnson is moving the therapy from late-stage clinical development into the commercial treatment landscape while continuing research into additional indications. The company stated that it will work with stakeholders across Europe to support the introduction and patient access to icotrokinra.
Source: Johnson & Johnson press release
