FDA approves ICOTYDE (icotrokinra), the first oral IL-23 receptor antagonist from Johnson & Johnson for moderate-to-severe plaque psoriasis in adults and adolescents eligible for systemic therapy.
Written By: Katherashala Dharan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration has approved ICOTYDE, an oral interleukin-23 (IL-23) receptor antagonist developed by Johnson & Johnson, for the treatment of adults and adolescents aged 12 years and older weighing at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
ICOTYDE is the first targeted oral peptide designed to selectively block the IL-23 receptor, a key pathway driving inflammatory responses in psoriasis. The therapy is taken as a once-daily pill, offering a systemic treatment option without injections.
Jennifer Taubert, Executive Vice President and Worldwide Chairman of Innovative Medicine at Johnson & Johnson, said the approval marks an important milestone in plaque psoriasis treatment and reflects the company’s commitment to delivering innovative therapies that help patients achieve meaningful disease control.
The approval is supported by data from the Phase 3 ICONIC clinical development program, which evaluated ICOTYDE across several randomized trials involving more than 2,500 patients with moderate-to-severe plaque psoriasis.
Head-to-head superiority versus Deucravacitinib was demonstrated in the Phase 3 ICONIC-ADVANCE 1 and 2 trials (NCT06143878; NCT06220604). Around 70% of patients achieved Investigator’s Global Assessment (IGA) 0/1, indicating clear or almost clear skin, and 55% achieved PASI 90 at Week 16. Adverse reaction rates were similar to placebo through Week 16, differing by about 1.1%, with no new safety signals observed through Week 52.
Linda Stein Gold, Director of Dermatology Clinical Research at Henry Ford Health, said ICOTYDE offers a unique option that combines strong skin clearance with a favorable safety profile in a once-daily oral therapy, which may make it easier for patients to incorporate systemic treatment into their daily routine.
John Reed, Executive Vice President of R&D for Innovative Medicine at Johnson & Johnson, described the approval as a pivotal step for people living with plaque psoriasis and said the therapy represents a new approach designed to change expectations for disease control.
The ICONIC Phase 3 program included multiple randomized trials assessing ICOTYDE in moderate-to-severe plaque psoriasis, including studies comparing the therapy with placebo and active treatments such as Ustekinumab. Additional trials are underway evaluating the therapy in other immune-mediated diseases including psoriatic arthritis, ulcerative colitis, and Crohn’s disease.
Leah M. Howard, President and CEO of the National Psoriasis Foundation, said the approval of a new systemic therapy expands the treatment conversation for patients and clinicians, allowing them to consider options that balance efficacy, safety, and how a treatment fits into everyday life.
Plaque psoriasis is a chronic immune-mediated condition characterized by inflamed, scaly plaques caused by rapid skin cell turnover. The disease affects more than 8 million people in the United States and over 125 million worldwide, with moderate-to-severe disease often requiring systemic therapy when topical treatments fail to provide adequate control.
For detailed safety information, including adverse reactions, warnings, and precautions, healthcare professionals should consult the official U.S. Prescribing Information:
https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ICOTYDE-pi.
References
FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide, 18 March 2026, FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide
A Study of JNJ-77242113 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis, ClinicalTrials.gov ID NCT06143878, https://clinicaltrials.gov/study/NCT06143878
A Study of JNJ-77242113 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2), ClinicalTrials.gov ID NCT06220604, https://clinicaltrials.gov/study/NCT06220604
Gold LS, 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, randomized, placebo-controlled and active-comparator-controlled trials. Lancet. 2025 Sep 27;406(10510):1363-1374. Epub 2025 Sep 18. PMID: 40976249, https://doi.org/10.1016/s0140-6736(25)01576-4
About the Writer
Katherashala Dharan Kumar, PharmD A dedicated Clinical Researcher with expertise in medical and scientific writing clinical trials, drug safety, and healthcare innovation. Actively contributes to research publications and clinical documentation focused on improving patient outcomes through evidence-based practices and ethical research standards. Believe that every complex data point has a human story waiting to be told. Focusing on providing actionable insights for clinical research.