｜Edited by the Content Team of Protagonist Therapeutics2025July of the Year21Day，Johnson & JohnsonAndProtagonist TherapeuticsAnnouncement of Submission to FDA for Market Approval of IL-23R Oral Cyclic Peptide Inhibitor Icotrokinra for the Treatment of Plaque Psoriasis. This market application is based onData from four pivotal Phase III clinical trials, includingICONIC-LEAD、ICONIC-TOTAL、ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2.Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, for the treatment of adults and pediatric patients aged 12 years and older with moderate to severe plaque psoriasis (PsO). Icotrokinra is uniquely designed to block the IL-23 receptor — a key receptor in plaqueThe basis of psoriasis inflammatory response, while also having potential application value in other IL-23 mediated diseases.The submission includes data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEADa, ICONIC-TOTALb, and ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2c. In the development program targeting adults and pediatric patients aged 12 years and older with moderate to severe plaque psoriasis, icotrokinra treatment achieved all primary and co-primary endpoints, demonstrating significant skin clearance and a favorable safety profile with once-daily oral dosing. Results from the ICONIC-ADVANCE 1 and 2 studies showed that icotrokinra met the co-primary endpoints and was superior to deucravacitinib in treating moderate to severe plaque psoriasis. Across all studies, pooled safety data indicated that the incidence of adverse events was 49.1% in the icotrokinra group compared to the placebo group.(51.9%) of patients experienced adverse events (AE), with no new safety signals identified to date.Plaque Psoriasis (PsO) is a chronic immune-mediated disease that causes excessive proliferation of skin cells, forming inflamed, scaly plaques that may be accompanied by itching or pain. It is estimated that 8 million people in the United States and over 125 million people worldwide are affected by this condition. Nearly one-quarter of plaque psoriasis patients have moderate to severe disease. Plaques typically appear as raised patches covered with silvery-white dead skin cells or scales. In individuals with lighter skin tones...In patients, the plaque may appear red; in patients with darker skin tones, it may appear purple, gray, or dark brown.About Icotrokinra (JNJ-77242113, JNJ-2113)The investigational drug icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor 1 — a receptor fundamental to the inflammatory response in moderate to severe plaque psoriasis and ulcerative colitis, while also showing potential in other IL-23 mediated diseases. Icotrokinra binds to the IL-23 receptor with picomolar (single-digit) affinity and demonstrates potent, selective inhibition of IL-23 signaling in human T cells.AboutJohnson & Johnson
Johnson & Johnson was founded in 1886 and is one of the most comprehensive healthcare product enterprises with a wide range of business operations globally, covering medical technology and innovative pharmaceuticals. Its headquarters is located in New Brunswick, New Jersey, USA. In 2023, Johnson & Johnson successfully completed the spin-off of its consumer health business and announced a brand renewal, integrating its two major businesses—medical technology and innovative pharmaceuticals—under the Johnson & Johnson name, marking a new chapter for the century-old company.
