FDA Approval

Icotyde (icotrokinra) Receives FDA Approval for Moderate-to-Severe Plaque Psoriasis

Anthony Calabro, MA

Key Highlights

  • Icotyde (icotrokinra) approved for moderate-to-severe plaque psoriasis in adults and adolescents ≥12 years weighing ≥40 kg
  • Approval supported by 4 phase 3 trials in approximately 2,500 patients from the ICONIC development program
  • Adverse event rates were within 1.1% of placebo through week 16, with no new safety signals through week 52

On March 18, 2026, the FDA approved Icotyde (icotrokinra), an oral peptide that targets the interleukin-23 (IL-23) receptor, for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 years and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy.

Icotrokinra is administered orally as a once-daily dose. The recommended regimen is 1 tablet taken in the morning on an empty stomach with water, at least 30 minutes prior to food intake

Approval was supported by data from 4 phase 3 studies within the ICONIC clinical development program, which included approximately 2,500 patients. These randomized trials evaluated icotrokinra in adults and adolescents, including patients with disease involving high-impact sites such as the scalp and genital areas, and included head-to-head studies versus an active comparator. In these studies, approximately 70% of patients treated with icotrokinra achieved Investigator’s Global Assessment (IGA) scores of 0 or 1, and 55% achieved a Psoriasis Area and Severity Index (PASI) 90 response at week 16.

The most common adverse events associated with icotrokinra included headache, nausea, cough, fungal infection, and fatigue. Treatment may increase the risk of infections, including tuberculosis, and patients should be monitored for signs and symptoms of infection. Adverse event rates were within 1.1% of placebo through week 16, and no new safety signals were identified through week 52.

Reference
Johnson & Johnson. FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide. Published March 18, 2026. Accessed March 19, 2026. https://www.jnj.com/media-center/press-releases/fda-approval-of-icotyde-icotrokinra-ushers-in-new-era-for-first-line-systemic-treatment-of-plaque-psoriasis-with-a-targeted-oral-peptide