ICONIC-LEAD: Durable Psoriasis Clearance Through 52 Weeks with Icotrokinra

Key Takeaways

• FDA approval of icotrokinra introduces the first oral IL-23 receptor–targeted peptide, with ~70% IGA 0/1 and 55% PASI 90 at week 16, according to the manufacturer.
• Durable efficacy was observed through 52 weeks, including >80% clear/almost clear skin and ~60% complete clearance in adolescents.
• Investigator Dr. Jennifer Soung noted the “biologic-like efficacy in a pill,” with no routine lab monitoring and expanded access for adolescents.

The US Food and Drug Administration (FDA) recently granted approval for the oral interleukin (IL)-23 receptor antagonist icotrokinra (ICOTYDE™, Johnson & Johnson) for patients aged 12 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

According the manufacturer, approval positions icotrokinra as the first oral peptide therapy to selectively block the IL-23 receptor, extending an established biologic mechanism into a once-daily oral formulation. The approval was supported by data from the phase 3 ICONIC program, which included approximately 2,500 patients. Data from the study indicated approximately 70% of patients achieved Investigator’s Global Assessment (IGA) 0/1 and 55% achieved PASI 90 at week 16, with adverse event rates within 1.1% of placebo and no new safety signals through 52 weeks, according to the company.

Additional data presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting further underlined durability, including in adolescents. In the ICONIC-LEAD study, more than 80% of patients maintained clear or almost clear skin between Weeks 24 and 52, and approximately 60% achieved complete clearance (IGA 0/PASI 100) over that period. Among Week 24 responders, about 90% maintained response at Week 52.

In an interview, Jennifer Soung, MD, an investigator in the icotrokinra clinical development program and on the ICONIC-LEAD study, framed the approval as a convergence of efficacy, safety, and convenience.

“What stands out is that you now have efficacy in terms of skin clearance like we’ve never seen before for an oral drug,” she told Practical Dermatology. “You’re seeing efficacy close to what biologics are like, but in a pill.”

Dr. Soung also emphasized the clinical implications of the safety profile and monitoring requirements. 

“There’s no routine laboratory monitoring and not even TB testing,” she said. “Essentially you have efficacy and excellent safety based off a well-known mechanism, and now the simplicity of it in a pill.”

She added that the approval of the combination therapy represents "a meaningful milestone in psoriasis care," noting that "more patients who need systemic treatment may actually receive it."

The inclusion of adolescents in the initial approval makes the approval that much more important, Dr. Soung said, as it expands its reach to populations who need the care.

“This is the first time a systemic has been approved at the same time for adults and adolescents,” she noted. “For many kids who are afraid of shots, this lowers the barrier to care at a really important stage of life.”