FDA Approves Icotrokinra, First Oral IL-23 Inhibitor for Plaque Psoriasis

The FDA today approved icotrokinra (Icotyde; Johnson & Johnson) for the treatment of adults and pediatric patients aged 12 years and older with moderate to severe plaque psoriasis, Johnson & Johnson announced in a press release.¹

Icotrokinra, which was approved based on data from studies in the phase 3 ICONIC clinical development program, is the first and only targeted oral peptide that precisely blocks the interleukin-23 (IL-23) receptor to achieve skin clearance in patients with plaque psoriasis. Its approval marks a shift in the delivery of systemic therapy for this patient population.

"[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," Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health, said in a statement.¹ "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 ICONIC program trials evaluated icotrokinra in adults and adolescents, included high-impact sites such as scalp and genital plaque psoriasis, and included head-to-head trials vs an active comparator, according to the press release. The program includes 5 randomized, controlled, phase 3 trials: ICONIC-LEAD (NCT06095115), ICONIC-TOTAL (NCT06095102), ICONIC-ADVANCE 1 (NCT06143878), ICONIC-ADVANCE 2 (NCT06220604), and ICONIC-ASCEND (NCT06934226).^2-6

In the ongoing head-to-head ICONIC-ADVANCE 1 and 2 trials, icotrokinra showed superiority over both placebo and deucravacitinib, an oral TYK2 inhibitor.⁷ At week 16, approximately 70% of patients receiving icotrokinra achieved an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin. Additionally, 55% of patients achieved at least a 90% improvement in Psoriasis Area and Severity Index (PASI 90), a benchmark increasingly used to define high-level treatment response in psoriasis trials.

The ICONIC-LEAD trial further demonstrated robust efficacy vs placebo, as coprimary end points PASI 90 and IGA 0/1 had at least a 2-grade improvement. Longer-term data from this study suggest maintenance of response through 52 weeks, including in adolescent populations.⁸ In ICONIC-TOTAL, which specifically evaluated patients with psoriasis affecting high-impact areas such as the scalp, genitals, hands, and feet—regions often associated with disproportionate quality-of-life burden—icatrokinra showed meaningful skin clearance in these harder-to-treat sites.⁹

Safety findings were favorable and consistent across the development program. Through week 16, rates of adverse events were within 1.1% of placebo, and no new safety signals were identified through 1 year of follow-up.¹ The most commonly reported adverse events included headache, nausea, cough, fatigue, and fungal infections. Infections are also a consideration with immune-modulating therapies, and screening for tuberculosis is recommended prior to initiation.

“With the FDA approval of [icotrokinra], Johnson & Johnson is setting a new standard for the treatment of moderate-to-severe plaque psoriasis,” Jennifer Taubert, executive vice president and worldwide chairman of Innovative Medicine at Johnson & Johnson, said in a statement.¹ “We’re proud to bring this game-changing innovation to the market, marking a transformative shift in plaque psoriasis management that empowers patients and clinicians to reach their treatment goals.”

Further studies are ongoing to evaluate icotrokinra in other immune-mediated conditions, including psoriatic arthritis, ulcerative colitis, and Crohn disease, which may help clarify the broader role of IL-23 receptor blockade across inflammatory diseases.

“Finding the right treatment can take time, during which people with psoriatic disease should be considering multiple factors from efficacy to safety to how the treatment fits into their everyday life,” Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation, said in a statement.¹ “The approval of a novel systemic therapy changes the conversation about treatment options for our community.”

References

1. FDA approval of Icotyde (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide. News release. Johnson & Johnson. March 18, 2026. Accessed March 18, 2026. https://www.investor.jnj.com/investor-news/news-details/2026/FDA-approval-of-ICOTYDE-icotrokinra-ushers-in-new-era-for-first-line-systemic-treatment-of-plaque-psoriasis-with-a-targeted-oral-peptide/default.aspx

2. Study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). ClinicalTrials.gov. Updated March 16, 2026. Accessed March 18, 2026. https://classic.clinicaltrials.gov/ct2/show/NCT06095115

3. Study of JNJ-2113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of the hands and the soles of the feet) (ICONIC-TOTAL). ClinicalTrials.gov. Updated March 13, 2026. Accessed March 18, 2026. https://classic.clinicaltrials.gov/ct2/show/NCT06095102

4. Study of JNJ-77242113 for the treatment of participants with moderate-to-severe plaque psoriasis. ClinicalTrials.gov. Updated March 12, 2026. Accessed March 18, 2026. https://clinicaltrials.gov/study/NCT06143878

5. Study of JNJ-77242113 for the treatment of participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 2). ClinicalTrials.gov. Updated March 12, 2026. Accessed March 18, 2026. https://clinicaltrials.gov/study/NCT06220604

6. Study to assess efficacy and safety of JNJ-77242113 compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis (ICONIC-ASCEND). ClinicalTrials.gov. Updated March 13, 2026. Accessed March 18, 2026. https://clinicaltrials.gov/study/NCT06934226

7. Gold LS, Armstrong AW, Bissonnette R, et al. Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): two phase 3, randomised, placebo-controlled and active-comparator-controlled trials. Lancet. 2025;406(10510):1363-1374. doi:10.1016/S0140-6736(25)01576-4

8. Icotrokinra shows superiority to deucravacitinib in first reported head-to-head trials reinforcing promise of novel targeted oral peptide for treatment of plaque psoriasis. News release. Johnson & Johnson. September 17, 2025. Accessed March 18, 2026. https://www.jnj.com/media-center/press-releases/icotrokinra-shows-superiority-to-deucravacitinib-in-first-reported-head-to-head-trials-reinforcing-promise-of-novel-targeted-oral-peptide-for-treatment-of-plaque-psoriasis

9. Icotrokinra long-term results affirm promise of targeted oral peptide with high rates of durable skin clearance and favorable safety profile in difficult-to-treat scalp and genital psoriasis. News release. Johnson & Johnson. October 24, 2025. Accessed March 18, 2026. https://www.jnj.com/media-center/press-releases/icotrokinra-long-term-results-affirm-promise-of-targeted-oral-peptide-with-high-rates-of-durable-skin-clearance-and-favorable-safety-profile-in-difficult-to-treat-scalp-and-genital-psoriasis