J&J Submits NDA for Icotrokinra, a New Type of Therapy for Plaque Psoriasis

Johnson & Johnson has submitted a new drug application to the FDA for icotrokinra to treat adults and adolescents 12 years of age and older with moderate-to-severe plaque psoriasis. Icotrokinra is a first-in-class targeted oral peptide that selectively blocks interleukin (IL) 23 and its receptor, which plays a key role in the inflammatory response in plaque psoriasis.

Icotronkinra is not like other therapeutics available to treat psoriasis. Currently available therapies for psoriasis include biologics, such as J&J’s Stelara (ustekinumab), which are derived from living cells that are harvested or grown in a lab, and small molecule drugs such as Bristol Myers Squibb’s Sotyktu (deucravacitinib), which are chemically synthesized compounds.

Peptides can specifically target cell receptors with fewer off-target effects than small molecules but can be less stable than biologics. Insulin and hormones are examples of peptides that are used as therapeutics, as are the glucagon-like peptide 1 (GLP-1) therapies used to treat diabetes and obesity.

J&J’s application for icotronkinra included data from four pivotal phase 3 studies conducted as part of the ICONIC clinical development program. Across the program, icotrokinra met all primary and co-primary endpoints, demonstrating significant skin clearance and a favorable safety profile in a once-daily pill. J&J officials said in a news release that, across all studies, pooled safety data showed a similar proportion of patients experienced adverse events between icotrokinra (49.1%) and placebo (51.9%) groups, with no new safety signals identified to date.

“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,” Liza O’Dowd, M.D., vice president, Immunodermatology and Respiratory Disease Area Lead, Johnson & Johnson Innovative Medicine, said in the news release.

Plaque psoriasis is a chronic immune system-mediated disease that causes an overproduction of skin cells. The result of that overproduction is scaly plaques that can be itchy or painful. A study of the prevalence of psoriasis published in JAMA Dermatology in 2021 concluded that the condition affects 3% of the adult population in the United States, or approximately 7.5 million people.

Related: Icotrokinra for Psoriasis: A Small Peptide Poised To Take On the Bigger Biologics | AAD 2025

Results from the phase 3 ICONIC-LEAD study were presented in March at the 2025 American Academy of Dermatology (AAD) Annual Meeting. In the trial, patients with plaque psoriasis were randomly assigned to either icotrokinra daily or a placebo pill. The trial enrolled 456 patients into the icotrokinra group and 228 into the placebo group.

At week 16 of the trial, 65% of those assigned to the icotrokinra group had an Investigator’s Global Assessment (IGA) score of 0 or 1 compared with 8% of those in the placebo group. Similarly, 50% in the icotrokinra group had a Psoriasis Area and Severity Index (PASI) 90 response compared with 4% in the placebo group. Both IGA and PASI 90 are commonly used to measure the response to psoriasis drugs.

A subgroup analysis of ICONIC-LEAD, presented at the 2025 World Congress of Pediatric Dermatology (WCPD), demonstrated pediatric patients 12 years of age and older treated with icotrokinra achieved higher rates of clear or almost clear skin at week 16 compared with patients receiving placebo.

Long-term data from the ICONIC development program, including at least 52 weeks of treatment in the ICONIC-LEAD and ICONIC-TOTAL studies, and results from a randomized withdrawal analysis evaluating the durability of response are being prepared for presentation at a future medical meeting, according to J&J officials.

Johnson & Johnson has initiated the phase 3 ICONIC-ASCEND study, which will be a head-to-head comparison of icotrokinra with its biologic, Stelara, which is now facing biosimilar competition. The company has also launched a head-to-head comparison of icotrokinra and Sotyktu.