Johnson & Johnson Submits Marketing Authorization Application to EMA for Icotrokinra, a First-in-Class Oral Peptide Therapy for Moderate-to-Severe Plaque Psoriasis
Johnson & Johnson
Medical Device R&D and Manufacturer
On September 11, 2025, Johnson & Johnson announced that it had submitted the first marketing application for Icotrokinra to the European Medicines Agency (EMA). This innovative targeted oral peptide is expected to offer a new treatment option for adult and adolescent patients aged 12 years and older with moderate to severe plaque psoriasis (Pso).
Icotrokinra is a first-in-class targeted oral peptide that can selectively block the IL-23 receptor. IL-23 plays a critical role in the inflammatory response of plaque psoriasis and also holds potential therapeutic value in other IL-23-mediated diseases. This innovative drug, in the form of a once-daily oral tablet, aims to deliver complete skin clearance and favorable safety, with the potential to revolutionize the treatment paradigm for plaque psoriasis.
This application is based on data from four key Phase III clinical studies, all of which are part of the ICONIC clinical development program, including ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2. These studies covered adult and adolescent patients aged 12 years and above with moderate to severe plaque psoriasis and met all primary and co-primary endpoints.
These data packages contain head-to-head superiority comparisons with deucravacitinib, confirming the outstanding performance of Icotrokinra in the treatment of moderate to severe plaque psoriasis. The study also evaluated difficult-to-treat skin areas (such as scalp and genital psoriasis) and found no new safety signals, further reinforcing its favorable safety profile.
Subgroup analysis of the ICONIC-LEAD study also showed that adolescent patients receiving once-daily Icotrokinra treatment achieved higher rates of skin clearance or near clearance at week 16, with no new safety signals identified. Additionally, long-term data (including treatment outcomes from ICONIC-LEAD and ICONIC-TOTAL for at least 52 weeks) as well as randomized withdrawal analysis data assessing durability of efficacy are being prepared and will be presented at future medical conferences.
Johnson & Johnson did not stop there and has launched the Phase III ICONIC-ASCEND study, the first head-to-head study aimed at demonstrating the superiority of the oral tablet Icotrokinra over the injectable biologic ustekinumab, marking an important step in psoriasis research. In addition to plaque psoriasis, Icotrokinra is also being actively explored for other IL-23-mediated diseases, including active psoriatic arthritis (ICONIC-PsA 1 and ICONIC-PsA 2 studies) and moderate to severe active ulcerative colitis (Phase IIb ANTHEM-UC study).
Johnson & Johnson and Protagonist Therapeutics reached a licensing and collaboration agreement in 2017,Jointly discover and develop the next generation of compounds, ultimately leading to Icotrokinra (JNJ-2113).According to the agreement, Johnson & Johnson retains global exclusive rights to develop Icotrokinra in Phase 2 clinical trials and beyond. In addition, Johnson & Johnson also has the right to commercialize compounds derived from research conducted under the agreement for a wide range of indications.
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