FDA Approves Icotrokinra (Icotyde): First Oral IL-23 Receptor Antagonist for Moderate-to-Severe Plaque Psoriasis

The US Food and Drug Administration (FDA) has approved icotrokinra (Icotyde) for the treatment of moderate-to-severe plaque psoriasis in adults and children aged 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy, Johnson & Johnson announced March 18, 2026.

According to the company, the approval marks the first for an oral targeted peptide that selectively blocks the IL-23 receptor, introducing a new mechanistic class to the systemic psoriasis treatment landscape. For primary care clinicians who manage psoriasis or coordinate care with dermatology, the once-daily oral formulation may offer a practical option for appropriate persons—particularly those who have not responded to or are not candidates for injectable biologics.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.”

The decision was supported by data from the phase 3 ICONIC program, which enrolled approximately 2500 participants aged 12 and older across 4 trials.¹

In the placebo-controlled ICONIC-LEAD trial, 65% of icotrokinra-treated participants 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. Responses deepened with continued treatment: by week 24, 74% reached IGA 0/1 and 65% achieved PASI 90.²

The ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 studies evaluated icotrokinra head-to-head against both placebo and deucravacitinib (Sotyktu). Icotrokinra demonstrated superiority to deucravacitinib for skin clearance at both weeks 16 and 24, with adverse event rates numerically lower in the icotrokinra group.³

ICONIC-TOTAL, which enrolled individuals with moderate or greater involvement of the scalp, genitalia, or hands and feet, showed that 72% of participants with scalp psoriasis and 85% with genital psoriasis achieved clear or almost clear skin at week 52.¹

Across the full program, rates of adverse reactions with icotrokinra were within 1.1 percentage points of placebo through week 16, and no new safety signals emerged through week 52.¹

“With the FDA approval of ICOTYDE, Johnson & Johnson is setting a new standard for the treatment of moderate-to-severe plaque psoriasis,” said Jennifer Taubert, executive vice president and worldwide chairman of Innovative Medicine at Johnson & Johnson. “We’re proud to bring this game-changing innovation to the market, marking a transformative shift in plaque psoriasis management that empowers participants and clinicians to reach their treatment goals.”

Johnson & Johnson has initiated ICONIC-ASCEND, a phase 3 head-to-head trial comparing icotrokinra against ustekinumab, which would be the first study designed to show superiority of an oral agent over an injectable biologic in this population. Phase 3 trials in psoriatic arthritis, ulcerative colitis, and Crohn's disease are also underway.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…
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