Icotrokinra, an Oral Il-23 Inhibitor, Receives FDA Approval for Psoriasis

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

The approval, announced by Johnson & Johnson on March 18, 2026, marks the first for an oral targeted peptide selectively blocking the IL-23 receptor and introduces a new mechanistic class to the psoriasis treatment landscape backed by data from multiple trials in the phase 3 ICONIC program.¹

“[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.”

ICONIC Phase 3 Program: From LEAD to ADVANCE

The approval is based on results from 4 phase 3 trials in the ICONIC program, enrolling approximately 2500 patients aged 12 and older. The program began with ICONIC-LEAD, a multicenter, randomized, double-blind, placebo-controlled study that first established the agent's efficacy and safety profile across adults and adolescents. Results indicated 65% of patients treated with icotrokinra achieved an IGA score of 0 or 1 at 16 weeks, compared to 8% of the placebo group (P <.001), and PASI 90 response rates were 50% for icotrokinra versus 4% for placebo (P <.001).²

Responses deepened with continued treatment: by week 24, 74% reached an IGA score of 0 or 1 and 65% achieved PASI 90, with 46% achieving complete skin clearance (IGA 0) and 40% reaching PASI 100.² In the adolescent subgroup, results were particularly strong, with 86.4% achieving IGA 0/1 and 88.6% achieving PASI 90 at week 24.²

A notable strength of the ICONIC program was its head-to-head design. ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 evaluated icotrokinra against both placebo and deucravacitinib in adults with moderate to severe plaque psoriasis.

Icotrokinra met both co-primary endpoints compared to placebo at week 16 and showed superiority to deucravacitinib for skin clearance at weeks 16 and 24, with adverse event rates numerically lower with icotrokinra relative to deucravacitinib through 24 weeks.³ Across the ICONIC-ADVANCE studies, approximately 70% of patients achieved IGA 0/1 and 55% achieved PASI 90 at week 16.¹

The program also specifically addressed high-impact disease sites through ICONIC-TOTAL, which evaluated patients with at least moderate severity affecting the scalp, genitalia, or hands and feet. At week 52, icotrokinra achieved clear or almost clear skin in 72% of patients with scalp psoriasis and 85% with genital psoriasis, with clearance rates in both sites substantially exceeding those seen with placebo at week 16.¹

Across the full program, rates of adverse reactions 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

What Comes Next

Johnson and Johnson has also initiated ICONIC-ASCEND, a head-to-head phase 3 trial comparing icotrokinra against ustekinumab, which would represent the first study designed to demonstrate superiority of an oral agent versus an injectable biologic in moderate to severe psoriasis, according to the company. Phase 3 studies in psoriatic arthritis, ulcerative colitis, and Crohn's disease are also underway, reflecting the broader relevance of IL-23 receptor blockade across immune-mediated conditions.¹

References

1. Johnson and 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. Accessed 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. Published August 08, 2025. Accessed March 18, 2026. https://www.hcplive.com/view/phase-3-findings-suggest-icotrokinra-effective-adults-adolescents-with-psoriasis

3. Campbell P. ICONIC-ADVANCE: icotrokinra bests deucravacitinib for plaque psoriasis. HCPLive. Published September 17, 2025. Accessed March 18, 2026. https://www.hcplive.com/view/iconic-advance-icotrokinra-bests-deucravacitinib-for-plaque-psoriasis