The FDA has approved icotrokinra (Icotyde, Johnson & Johnson), the first interleukin-23 (IL-23) oral targeted therapy for the treatment of moderate-to-severe plaque psoriasis, the manufacturer announced today in a press release. 

Icotrokinra, the first oral peptide that blocks the IL-23 receptor, provides complete skin clearance and a favorable safety profile in a once-daily pill. The approved indication is for adults and children at least 12 years old who weigh at least 40 kg (88 lb) and are candidates for systemic therapy or phototherapy.

“The approval of a novel systemic therapy changes the conversation about treatment options for our community,” Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation, said in the company’s press release. 

“Dermatologists have long faced an unmet need for oral treatment options for patients with moderate-to-severe plaque psoriasis,” Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health in Detroit, told Medscape Medical News.

“Icotrokinra introduces a differentiated oral option, with clinical data suggesting efficacy approaching that of biologic therapies, along with a favorable safety and tolerability profile. The convenience of once-daily oral dosing and approval for patients aged 12 years and older expands options for shared decision making, particularly for patients seeking alternatives to injectable therapies.”

She noted that in clinical trials involving patients with moderate-to-severe plaque psoriasis, “improvements compared with placebo were observed as early as week 4.”

Approval Based on Multiple Randomized Trials 

Approval is based on results from the phase 3 ICONIC clinical development program, which evaluated icotrokinra across multiple randomized trials in people with moderate-to-severe psoriasis. The trials included approximately 2500 patients, including studies in high-impact sites such as scalp and genital psoriasis.

Icotrokinra met all primary efficacy endpoints and demonstrated a favorable safety profile in four phase 3 studies, according to the company. In the head-to-head superiority studies, approximately 70% of patients experienced clear or almost clear skin (Investigator’s Global Assessment 0/1, on a 5-point scale where 0 is clear) and 55% of patients achieved a Psoriasis Area and Severity Index 90 response at week 16. Rates of adverse reactions for patients treated with icotrokinra were within 1.1% of placebo through week 16, and no new safety signals were identified through week 52.

In November 2025, Medscape Medical News reported on 16-week results from one of the phase 3 trials, ICONIC-LEAD, which showed that icotrokinra provided a level of response in moderate-to-severe plaque psoriasis patients similar to that previously reported with injectable biologics. Results were published in The New England Journal of Medicine.

Advantages Compared With Biologics 

The lead author of the NEJM paper, Robert Bissonnette, MD, founder and chairman of Innovaderm Research, Montreal, Québec, Canada, told Medscape Medical News at the time, “In my opinion, the main advantages of icotrokinra as compared to biologics targeting IL-23 is the oral administration and short half-life. A short half-life is very important when a patient needs to stop treatment before an upcoming surgery, because of an infection, or because they want to become pregnant.”

Information on safety, included in the press release, notes that icotrokinra may cause serious side effects such as infections and that m edicines that interact with the immune system, such as icotrokinra, may lower the ability to fight infections and may increase risk of infections. Healthcare providers should watch closely for signs and symptoms of tuberculosis during and after treatment with icotrokinra, the manufacturer cautions. The most common side effects of icotrokinra include headache, nausea, cough, fungal infection, and fatigue.

Icotrokinra is also being studied in active psoriatic arthritis (biologic-experienced and biologic-naive patients), moderately-to-severely active ulcerative colitis, and moderately-to-severely active Crohn's disease, according to the company.

Prescribing information is available here.

Stein Gold is a paid consultant for Johnson & Johnson. She has not been compensated for any media work.

Marcia Frellick is an independent, Chicago-based healthcare journalist and a regular contributor to Medscape.