FDA Approves Icotyde (icotrokinra) for Moderate-to-Severe Plaque Psoriasis in Patients 12 and Older

The U.S. Food and Drug Administration approved ICOTYDE™ (icotrokinra) on March 18, 2026, for the treatment of moderate-to-severe plaque psoriasis in patients 12 years and older weighing at least 40 kilograms, Johnson & Johnson announced from Spring House, Pennsylvania. The oral peptide, which targets the interleukin-23 receptor, demonstrated significant efficacy in four Phase 3 studies involving approximately 2,500 patients, meeting all primary endpoints, company officials said.

ICOTYDE™ (icotrokinra) is the first oral peptide approved by the U.S. Food and Drug Administration that targets the interleukin-23 receptor (IL-23R) for the treatment of moderate-to-severe plaque psoriasis, Johnson & Johnson officials said in a March 18, 2026, announcement from Spring House, Pennsylvania. The approval covers adults and pediatric patients aged 12 years and older who weigh at least 40 kilograms and are candidates for systemic therapy or phototherapy, company representatives confirmed.

Results from the Phase 3 trials showed that about 70% of patients achieved clear or almost clear skin, defined as an Investigator’s Global Assessment (IGA) score of 0 or 1, at Week 16 in the head-to-head superiority studies, officials reported.

The FDA’s decision was based on data from the ICONIC clinical development program, which comprised four Phase 3 studies enrolling approximately 2,500 patients, including both adults and adolescents, sources said. These randomized controlled trials assessed ICOTYDE’s efficacy and safety across high-impact sites such as scalp and genital psoriasis and included duplicate head-to-head superiority studies against an active comparator, according to Johnson & Johnson and Protagonist Therapeutics, the latter of which highlighted the drug’s novel mechanism of action.

Additionally, 55% of participants reached a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) by Week 16, demonstrating significant skin clearance compared to placebo and active comparator arms, according to clinical trial records.

One of the pivotal studies, ICONIC-ASCEND (NCT06934226), was a randomized controlled trial comparing ICOTYDE to placebo and ustekinumab, an established biologic therapy. The trial confirmed the oral peptide’s efficacy in moderate-to-severe plaque psoriasis patients, Johnson & Johnson representatives stated, adding that the program provided an unprecedented body of evidence for skin clearance in this patient population.

Safety data collected through Week 52 indicated that adverse reactions with ICOTYDE were within 1.1% of placebo, with no new safety signals identified during the extended follow-up period, company officials said. The most commonly reported adverse events included headache, nausea, cough, fungal infections, and fatigue. The treatment may increase the risk of infections, including tuberculosis, and patients should be monitored accordingly, according to prescribing information.

Jennifer Taubert, executive vice president and worldwide chairman of Innovative Medicine at Johnson & Johnson, said the FDA approval “sets a new standard for the treatment of moderate-to-severe plaque psoriasis.” John Reed, M.D., Ph.D., executive vice president of research and development at Johnson & Johnson, described the approval as “a pivotal moment for people with plaque psoriasis,” the company’s news release stated.

Protagonist Therapeutics emphasized the significance of ICOTYDE as the first IL-23R targeted oral peptide for complete skin clearance, noting that the approval “demonstrates the strength of our peptide technology platform,” according to statements from Dinesh V., a company representative. The drug’s development represents the culmination of more than 13 years of research into peptide therapeutics, Protagonist officials said.

ICOTYDE is administered as a once-daily oral pill, providing a convenient treatment option for patients eligible for systemic therapy or phototherapy, Johnson & Johnson reported. The simultaneous evaluation of adults and adolescents in the Phase 3 trials supports its expanded indication for younger patients weighing at least 40 kilograms.

The approval of ICOTYDE marks a shift in plaque psoriasis management by introducing a targeted oral therapy option, officials said. Johnson & Johnson and Protagonist Therapeutics continue to monitor post-approval safety and efficacy data as the drug becomes available to patients.