The U.S. Food and Drug Administration (FDA) has approved the drug Icotyde (icotrokinra) from pharmaceutical companies Johnson & Johnson and Protagonist Therapeutics for the treatment of moderate to severe psoriasis in patients aged 12 years and older. Experts are calling the approval a “turning point” in psoriasis therapy. It is the first oral interleukin-23 (IL-23) receptor antagonist that can be taken once daily, distinguishing it from the injectable biologics that currently dominate the market.
In Phase III clinical trials involving 2,500 people, Icotyde demonstrated high efficacy. Approximately 70% of patients achieved complete or almost complete skin clearance, and more than half (55%) achieved 90% improvement on the PASI scale at week 16. In a head-to-head comparison, the drug showed superiority over the competing agent Sotyktu (deucravacitinib) from Bristol Myers Squibb, maintaining results for up to 52 weeks.
Linda Stein Gold, Director of Dermatology Research at Henry Ford Health, noted that the drug meets new recommendations from the International Psoriasis Council, which suggest an early transition to systemic therapy. Johnson & Johnson emphasized that Icotyde combines “biologic-level efficacy” with the convenience of oral administration, a feat previously considered unattainable.
Analysts predict a rapid market uptake for the drug and peak sales ranging from $5 billion to $7.5 billion. According to Fierce Pharma, Icotyde strengthens Johnson & Johnson’s immunology portfolio, which generated $15 billion for the company in 2025, driven by drugs like Stelara and Tremfya.
Johnson & Johnson and Protagonist, who have been collaborating in immunology since 2017, are already testing Icotyde for other conditions — psoriatic arthritis, ulcerative colitis, and Crohn’s disease. In parallel, the partners are comparing the drug to Stelara in the treatment of psoriasis.
For Protagonist Therapeutics, this approval is a pivotal event, coinciding with the anticipation of an FDA decision on rusfertide, a drug developed with Takeda for the treatment of polycythemia.
Plaque psoriasis is a chronic immune-mediated disease affecting millions of people worldwide. Icotrokinra is being developed by Johnson & Johnson in collaboration with Protagonist Therapeutics, Inc. and is also being tested for the treatment of psoriatic arthritis and ulcerative colitis.