J&J Seeks First FDA Approval for Icotrokinra to Treat Plaque Psoriasis

On Jul 22, 2025

Johnson & Johnson has officially submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for icotrokinra, an investigational first-in-class oral peptide designed to selectively block the IL-23 receptor. The drug targets moderate to severe plaque psoriasis (PsO) in adults and pediatric patients aged 12 and older.

Icotrokinra’s unique mechanism inhibits the IL-23 receptor, a key driver of the inflammatory response in plaque psoriasis and potentially other IL-23-mediated diseases. The NDA submission is supported by data from four pivotal Phase 3 studies under the ICONIC clinical program — ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 & 2.

Across these studies, icotrokinra met all primary and co-primary endpoints, demonstrating significant skin clearance and a favorable safety profile with once-daily oral dosing. Notably, results from ICONIC-ADVANCE 1 and 2 showed that icotrokinra not only met efficacy goals but also outperformed deucravacitinib, another oral psoriasis treatment. Safety data pooled across trials indicated similar adverse event rates between icotrokinra (49.1%) and placebo (51.9%), with no new safety concerns identified.

Dr. Liza O’Dowd, Vice President of Immunodermatology at Johnson & Johnson, highlighted the unmet needs in psoriasis treatment: “The rapid enrollment in our ICONIC trials reflects the demand for advanced therapies that better meet patient needs. We believe icotrokinra has the potential to transform plaque psoriasis care and set a new treatment standard.”

Key data submitted to the FDA include:

ICONIC-LEAD results demonstrating significant skin clearance at Week 16, including in pediatric patients, with no new safety issues.
ICONIC-TOTAL data showing efficacy in hard-to-treat areas such as scalp and genital psoriasis.
ICONIC-ADVANCE 1 & 2 confirming superiority over placebo and deucravacitinib at Weeks 16 and 24.
Long-term data from up to 52 weeks of treatment, with durability of response analyses forthcoming.

Johnson & Johnson has also launched the Phase 3 ICONIC-ASCEND trial, the first head-to-head study comparing an oral psoriasis pill (icotrokinra) against an injectable biologic (ustekinumab), marking a significant milestone in psoriasis treatment research.

The company plans to present comprehensive results from these studies at upcoming medical conferences as it seeks regulatory approval to bring this innovative oral therapy to patients with moderate to severe plaque psoriasis.