Johnson & Johnson Submits NDA for Icotrokinra in Adolescents, Adults with Psoriasis

Johnson & Johnson announced the submission of the first New Drug Application (NDA) to the US Food and Drug Administration (FDA) for icotrokinra, aiming for an indication as a treatment for adults and pediatric patients 12 years of age and older with moderate-to-severe plaque psoriasis.1

The July 21, 2025 announcement by Johnson & Johnson of this NDA submission highlights icotrokinra’s design as a first-in-class investigational targeted oral peptide. The drug selectively blocks the interleukin (IL)-23 receptor, a key driver of inflammation in psoriasis, as a means to address the inflammatory skin condition among the patient population indicated for the medication.

"The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment that meaningfully addresses their needs and preferences," Liza O'Dowd, MD, vice president and Immunodermatology and Respiratory Disease Area Lead at Johnson & Johnson Innovative Medicine, said in a statement.1

The company’s NDA submission was supported by data resulting from a set of four phase 3 analyses conducted as part of the ICONIC clinical program: ICONIC-LEADa, ICONIC-TOTALb, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2c. Icotrokinra was shown, across each of these trials, to have consistently met all primary and co-primary endpoints in individuals aged 12 years and older with psoriasis.

In their announcement, Johnson & Johnson highlight that the ICONIC-ADVANCE 1 and 2 trials demonstrated that icotrokinra not only met its co-primary endpoints but also outperformed deucravacitinib in treating moderate-to-severe psoriasis. They further noted the pooled safety data across the entire development program, all of which showed comparable adverse event (AE) rates between the icotrokinra and placebo cohorts and a lack of new safety concerns.

In the ICONIC-LEAD analysis, the results of which were presented as a late-breaking abstract at the 2025 American Academy of Dermatology (AAD) Annual Meeting, icotrokinra demonstrated statistically significant improvements in both of its co-primary endpoints. Specifically, an Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear skin) and a 90% reduction in Psoriasis Area and Severity Index (PASI 90) scores compared with placebo at the 16-week mark.

In a subgroup analysis of ICONIC-LEAD, presented during the 2025 World Congress of Pediatric Dermatology (WCPD), adolescents ≥12 years of age given a once-daily icotrokinra treatment regimen were found to have higher rates of IGA 0/1 at the 16-week mark versus placebo. Additionally, no new safety signals were identified by the investigators.

ICONIC-ADVANCE 1 and 2 studies were also used to confirm the medication’s efficacy, as icotrokinra met its co-primary endpoints of IGA 0/1 and PASI 90 at 16 Weeks compared to those in the placebo arm. The drug also attained all of its key secondary endpoints at the 16 and 24-week marks, with superiority to deucravacitinib being demonstrated by the investigators.

In ICONIC-TOTAL, the contents of which were presented at the 2025 Society for Investigative Dermatology (SID) Annual Meeting, the investigative team demonstrated icotrokinra’s potential efficacy in addressing challenging locations impacted by psoriasis. These included the scalp and genital areas of the body.

The announcement highlighted additional long-term results, covering at least 52 weeks of treatment in ICONIC-LEAD and ICONIC-TOTAL. It also pointed to the findings drawn from a randomized withdrawal analysis evaluating patients’ durability of response. These data were noted as being currently prepared for future medical presentations.

The ICONIC-ASCEND trial was also highlighted in the announcement as ongoing. The study is the first head-to-head phase 3 analysis comparing an oral therapy (icotrokinra) to ustekinumab, an injectable biologic. The investigators of ICONIC-ASCEND seek to establish the oral agent’s superiority in the psoriasis treatment landscape.2

"Given the breadth and depth of our studies, along with the robust clinical results reported to date, we are confident that icotrokinra has the potential to transform how physicians and patients think about plaque psoriasis care, establishing a new standard in the treatment of this immune-mediated disease,” O’Dowd said in her statement.1

References

1. Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis. Johnson & Johnson. July 21, 2025. https://www.prnewswire.com/news-releases/johnson--johnson-seeks-first-icotrokinra-us-fda-approval-aiming-to-revolutionize-treatment-paradigm-for-adults-and-adolescents-with-plaque-psoriasis-302509221.html?tc=eml_cleartime.

2. Clinicaltrials.gov. A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ASCEND). Identifier NCT0693422. Accessed July 21, 2025. https://clinicaltrials.gov/study/NCT06934226?term=iconic-ascend&rank=1.