FDA Approves Icotyde as Treatment for Plaque Psoriasis

The FDA approved icotrokinra (Icotyde) as a first-line systemic treatment of plaque psoriasis with a targeted oral peptide for adults and pediatric patients 12 years and older, weighing at least 40 kg, who are candidates for systemic or phototherapy. This represents the first and only therapy of its kind to precisely block the IL-23 receptor.¹

Developed by Johnson & Johnson, this once-daily pill is designed to address the needs of patients who have cycled through topical treatments without achieving adequate relief, offering a new standard for managing a disease that affects over 8 million Americans.

“Icotyde 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 news release. “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 Icotyde is a potential game changer for many adult and adolescent patients.”

For pharmacists, the clinical evidence supporting this approval is substantial, rooted in the ICONIC clinical development program that evaluated the drug across 5 phase 3 studies involving approximately 2500 patients. In head-to-head superiority trials, approximately 70% of patients achieved clear or almost clear skin as measured by an investigator global assessment (IGA) score of 0 or 1 at Week 16. Additionally, 55% of patients achieved a psoriasis area and severity index (PASI) 90 response, indicating at least a 90% improvement in skin clearance.^1,2

Further data from the ICONIC-LEAD (NCT06095115) study showed that nearly half of the participants reached completely clear skin by week 24, underscoring the potential for this oral peptide to compete with traditional injectable therapies.^2,3

The administration of icotrokinra involves specific counseling points that are critical for pharmacy practice. Patients are instructed to take one 200 mg pill once daily with water upon waking, on an empty stomach, and must wait at least 30 minutes before eating food. For patients who struggle with swallowing tablets, the medication can be dispersed in water, providing a flexible administration option that may bolster adherence. If a dose is missed, patients should take it as soon as they remember and return to their regular schedule the following day.¹

Safety considerations for this new systemic agent are largely consistent with other immunomodulators. Clinical trials indicated that adverse reaction rates for treated patients were within 1.1% of those in the placebo group through 16 weeks, with no new safety signals emerging through 52 weeks of continuous treatment.

However, because the drug interacts with the immune system, it may increase the risk of infections. Pharmacists should ensure that health care providers have screened patients for tuberculosis prior to starting treatment and should advise patients to avoid live vaccines during therapy. Common adverse effects observed during trials included headache, fungal infections, nausea, tiredness, and cough.

The introduction of icotrokinra aligns with evolving clinical guidelines from the International Psoriasis Council, which recommends a transition to systemic therapy if 2 4-week cycles of topical medications fail to bring meaningful improvement. Psoriasis is a chronic autoimmune condition characterized by the rapid overproduction of skin cells, which can lead to painful or itchy plaques on the scalp, torso, and sensitive high-impact sites such as the genitals or palms. By providing an oral alternative that offers the efficacy typically associated with biologics, icotrokinra represents a significant shift in the treatment paradigm.^1,2,4

“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 the news release.¹ “The approval of a novel systemic therapy changes the conversation about treatment options for our community.”

Johnson & Johnson has also initiated the ICONIC-ASCEND (NCT06934226) study, which is the first-ever head-to-head trial designed to demonstrate the superiority of this oral pill against the injectable biologic ustekinumab.

READ MORE: Autoimmune Diseases Resource Center

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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 and Johnson. March 18, 2026. Accessed March 18, 2026. https://www.multivu.com/johnson-johnson/9378651-en-icotyde-icotrokinra-fda-approval-first-line-systemic-treatment-plaque-psoriasis

2. Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis. News release. Johnson and Johnson. March 8, 2025. Accessed March 18, 2026. https://www.prnewswire.com/news-releases/icotrokinra-results-show-potential-to-set-a-new-standard-of-treatment-in-plaque-psoriasis-302396171.html

3. A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis (ICONIC-LEAD). ClinicalTrials.gov identification: NCT06095115. Updated March 16, 2026. Accessed March 18, 2026. https://clinicaltrials.gov/study/NCT06095115

4. Cleveland Clinic. Plaque psoriasis. April 25, 2022. Accessed March 18, 2026. https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis