European Commission Approves ICOTYDE (icotrokinra), First Targeted Oral IL-23 Receptor Peptide for Plaque Psoriasis
核心洞察
Johnson & Johnson received European Commission marketing authorisation for ICOTYDE (搜索) (icotrokinra), a once-daily oral IL-23 receptor (搜索) antagonist for moderate-to-severe plaque psoriasis (搜索) in patients aged 12 and older.
The approval covers adults and adolescents weighing at least 40 kg who are candidates for systemic therapy, making icotrokinra the first targeted oral peptide to block the IL-23 receptor (搜索).
Across four Phase 3 ICONIC trials in about 2,500 patients, icotrokinra met all primary endpoints, with roughly 70% achieving IGA 0/1 and 55% achieving PASI 90 at Week 16 in head-to-head studies.
Johnson & Johnson announced on 21 September 2026 that the European Commission has granted Marketing Authorisation for ICOTYDE (搜索) (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for adults and adolescents aged 12 years and older weighing at least 40 kg with moderate-to-severe plaque psoriasis (搜索) who are candidates for systemic therapy. Icotrokinra is the first targeted oral peptide designed to precisely block the IL-23 receptor (搜索), and the approval makes it the first such agent available as a once-daily oral option in this indication.
"For many people living with moderate-to-severe plaque psoriasis (搜索), the burden of disease remains substantial, but currently available systemic treatments do not consistently meet patients' treatment needs. There remains an ongoing unmet need for additional treatment options, regardless of route of administration," said Lluís Puig, Professor of Dermatology at Universitat Autònoma de Barcelona. "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 (搜索), it combines high levels of skin clearance, a favourable safety profile, and the convenience of once-daily oral administration."
Phase 3 ICONIC Programme Results
The European Commission decision is supported by four Phase 3 studies in the ICONIC clinical development programme, which enrolled approximately 2,500 patients and evaluated icotrokinra simultaneously in adults and adolescents aged 12 and older weighing at least 40 kg. According to Johnson & Johnson, icotrokinra met all primary efficacy endpoints and demonstrated a favourable safety profile across the programme.
The programme included patients with involvement of high-impact sites such as scalp and genital psoriasis, and two head-to-head studies against an active comparator. In those head-to-head studies, approximately 70% of patients treated with icotrokinra achieved clear or almost clear skin as measured by an Investigator's Global Assessment (IGA) score of 0 or 1, and 55% achieved a PASI 90 response at Week 16. The IGA is a five-point scale scored from 0 to 4, where 0 indicates clear skin and 4 indicates severe disease. PASI 90 corresponds to an improvement of at least 90% from baseline in the Psoriasis Area and Severity Index, which grades the surface area covered by plaques and their redness, thickness and scaliness.
Rates of adverse reactions among icotrokinra-treated patients were within 1.1% of placebo rates through Week 16, and no new safety signals were observed through Week 52. In line with EMA regulations for new medicines, icotrokinra is subject to additional monitoring.
Trial Design Across the ICONIC Studies
ICONIC-LEAD (NCT06095115) is a Phase 3 randomised controlled trial evaluating icotrokinra versus placebo in 684 participants (icotrokinra 456; placebo 228) aged 12 years or older with moderate-to-severe plaque psoriasis (搜索). Its co-primary endpoints were PASI 90 and an IGA score of 0/1 with at least a 2-grade improvement versus placebo at Week 16. The trial enrolled 66 adolescent patients.
ICONIC-TOTAL (NCT06095102) is a Phase 3 randomised controlled trial comparing icotrokinra with placebo in 311 participants (icotrokinra 208; placebo 103) with at least 1% body surface area involvement, at least mild disease (global IGA of 2 or higher) and at least moderate severity affecting high-impact sites such as the scalp, genital area, and/or hands and feet. The primary endpoint was the proportion of patients achieving an overall IGA score of 0 or 1 with at least a 2-grade improvement versus placebo at Week 16.
ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604) are Phase 3 randomised controlled trials evaluating icotrokinra against placebo and deucravacitinib in participants with moderate-to-severe plaque psoriasis (搜索), with PASI 90 and IGA 0/1 with at least a 2-grade improvement versus placebo at Week 16 as co-primary endpoints.
Dosing and Mechanism
Icotrokinra binds to the IL-23 receptor (搜索) with high affinity and demonstrated potent, selective inhibition of IL-23 signalling in human T cells, according to the company. The clinical significance of these findings is unknown. Patients take one pill once daily with water upon waking, at least 30 minutes before eating food.
"The approval of icotrokinra represents a defining milestone for eligible people living with moderate-to-severe plaque psoriasis (搜索)," said Mark Graham, Therapeutic Area Head, Immunology, J&J Innovative Medicine EMEA. "As the first targeted oral peptide to block the IL-23 receptor (搜索), icotrokinra represents a landmark scientific advance and has the potential to transform the treatment paradigm of plaque psoriasis for patients."
Unmet Need in Moderate-to-Severe Disease
An estimated 6.4 million people in Europe live with plaque psoriasis (搜索), a chronic immune-mediated disease in which overproduction of skin cells causes inflamed, scaly plaques that may be itchy or painful. More than 125 million people worldwide live with the disease, and nearly one-quarter of all cases are considered moderate-to-severe. Plaques most often appear on the scalp, knees, elbows and torso, and involvement of highly visible or sensitive areas such as the scalp, hands, feet and genitals can have an increased negative impact on quality of life.
According to Johnson & Johnson, most people living with moderate-to-severe plaque psoriasis (搜索) are eligible for, but are not receiving, systemic treatment. An oral therapy that selectively inhibits the IL-23 pathway by directly targeting the IL-23 receptor (搜索) could help address the unmet needs and preferences of patients. This aligns with International Psoriasis Council guidance to transition to systemic therapy if two cycles of topical medications applied for four weeks fail to bring meaningful improvement.
Development Beyond Psoriasis
Icotrokinra was jointly discovered and is being developed under a license and collaboration agreement between Protagonist Therapeutics and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond and to commercialise compounds derived from the research conducted under the agreement across a broad range of indications.
Additional studies are underway in other disease areas: ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) in active psoriatic arthritis (搜索), ICONIC-UC (NCT07196748) in moderately-to-severely active ulcerative colitis (搜索), and ICONIC-CD (NCT07196722) in moderately-to-severely active Crohn's disease (搜索). Johnson & Johnson said it is working with stakeholders across Europe to support the introduction of icotrokinra and help enable patient access.