FDA Approves Icotrokinra, the First Targeted Oral Treatment for Moderate to Severe Plaque Psoriasis

The U.S. Food and Drug Administration (FDA) has approved icotrokinra (Icotyde), a first-of-its-kind oral treatment for moderate to severe plaque psoriasis in adults and adolescents 12 years and older, marking a significant shift in how this condition can be managed.

Developed by Johnson & Johnson, icotrokinra is the first and only targeted oral peptide that works by precisely blocking the IL-23 receptor, a key driver of the inflammation behind plaque psoriasis. Until now, targeted biologics for psoriasis have required injections. Icotrokinra offers that same precision in a pill.

“[Icotrokinra] 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," said Linda Stein Gold, M.D., director of Dermatology Clinical Research at Henry Ford Health. “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 [icotrokinra] is a potential game changer for many adult and adolescent patients.”

The approval is backed by the ICONIC clinical program, a comprehensive psoriasis trial spanning four Phase 3 studies and more than 2,500 patients, including both adults and adolescents. In head-to-head superiority trials against an active comparator, approximately 70% of patients achieved clear or almost clear skin at Week 16, and 55% reached a Psoriasis Area and Severity Index 90 response, meaning at least a 90% reduction in disease severity. The safety profile was also strong, with adverse reaction rates within 1.1% of placebo through Week 16 and no new safety signals identified through Week 52.

Psoriasis affects more than 8 million Americans, with moderate to severe disease significantly affecting quality of life, particularly when lesions appear on the scalp, face or genital areas. For patients who have cycled through topical treatments without meaningful relief, icotrokinra represents a new and more accessible option — no injections, no infusions, just a targeted oral therapy backed by a robust body of clinical evidence.

“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,” said Leah M. Howard, J.D., president and CEO of the National Psoriasis Foundation. “The approval of a novel systemic therapy changes the conversation about treatment options for our community.”