FDA approves icotrokinra, first oral targeted peptide for plaque psoriasis

The FDA has approved icotrokinra (Icotyde) for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy.

The announcement, made by Johnson & Johnson on March 18, 2026, marks the first approval of an oral targeted peptide that selectively blocks the interleukin (IL)–23 receptor.

“[Icotrokinra] delivers something unique in psoriasis treatment – combining skin clearance with a favorable safety profile in a once‑daily pill, making it an easy addition to a patient’s routine," said Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health. “With new guidance from the International Psoriasis Council that clarifies when to move beyond cycling on topical treatments to systemic therapy, an innovative option like [icotrokinra] is a potential game‑changer for many adult and adolescent patients.”

A New Mechanism in Psoriasis Management

Icotrokinra works by selectively blocking the IL-23 receptor, a key driver of the inflammatory cascade underlying plaque psoriasis. Unlike injectable biologics that target IL-23 itself or its downstream mediators, icotrokinra is a targeted oral peptide, a mechanistic and formulation distinction that sets it apart from every currently approved systemic option.

For adolescent patients, in particular, the once-daily oral dosing may support adherence in ways preferable to available injectable regimens, particularly in patients or families with needle aversion or logistical barriers to in-office or self-administered injections.

Phase 3 ICONIC Program

The approval was supported by data from 4 trials in the phase 3 ICONIC program, which enrolled approximately 2500 patients 12 years and older.

The pivotal ICONIC-LEAD trial was a multicenter, randomized, double-blind, placebo-controlled study established icotrokinra’s efficacy and safety in both adults and adolescents. Overall, 65% of treated patients achieved an Investigator's Global Assessment (IGA) score of 0 or 1 at 16 weeks, compared with 8% in the placebo group. PASI 90 response rates were 50% vs 4%, respectively. These responses continued to deepen with sustained treatment: by week 24, 74% reached IGA 0/1, 65% achieved PASI 90, and 46% achieved complete skin clearance (IGA 0).²

Of note, the adolescent subgroup outperformed the overall population. At week 24, 86.4% of adolescent patients achieved IGA 0/1 and 88.6% achieved PASI 90.²

Head-to-Head and High-Impact Disease Sites

The ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 trials brought additional context by comparing icotrokinra directly against deucravacitinib (Sotyktu), the oral tyrosine kinase 2 inhibitor approved for moderate to severe plaque psoriasis in adults.

Icotrokinra met both co–primary end points vs placebo at week 16 and demonstrated superiority over deucravacitinib for skin clearance at weeks 16 and 24, with adverse event rates that were numerically lower with icotrokinra through 24 weeks.³ Across both ICONIC-ADVANCE studies, approximately 70% of patients achieved IGA 0/1 and 55% achieved PASI 90 at week 16.¹

ICONIC-TOTAL addressed disease sites that are disproportionately impactful on quality of life, enrolling patients with at least moderate psoriasis severity affecting the scalp, genitalia, or hands and feet. At week 52, 72% of patients with scalp psoriasis and 85% with genital psoriasis achieved clear or almost clear skin, with clearance rates substantially exceeding placebo outcomes at week 16.¹

Safety Profile

Across the full ICONIC program, adverse reaction rates in icotrokinra-treated patients were within 1.1 percentage points of placebo through week 16, and no new safety signals were identified through week 52.¹ This placebo-comparable tolerability profile over nearly a year of follow-up is an important consideration for clinicians weighing long-term systemic therapy in adolescent patients, particularly given the chronic, relapsing nature of moderate to severe plaque psoriasis and the likelihood that many patients will require sustained treatment.

References

1. Johnson & Johnson. FDA approves ICOTYDE (icotrokinra), the first and only targeted oral peptide IL-23 receptor antagonist, for the treatment of moderate-to-severe plaque psoriasis. Press release. Published March 18, 2026. https://www.jnj.com/media-center/press-releases
2. Smith T. Phase 3 findings suggest icotrokinra effective in adults, adolescents with psoriasis. HCPLive. August 8, 2025. https://www.hcplive.com/view/phase-3-findings-suggest-icotrokinra-effective-adults-adolescents-with…
3. Campbell P. ICONIC-ADVANCE: icotrokinra bests deucravacitinib for plaque psoriasis. HCPLive. September 17, 2025. https://www.hcplive.com/view/iconic-advance-icotrokinra-bests-deucravacitinib-for-plaque-psoriasis