Johnson & Johnson announced on Mar. 18 that the U.S. Food and Drug Administration has approved its IL-23 receptor blocker, icotrokinra, for the treatment of moderate-to-severe plaque psoriasis. The new drug, developed in partnership with Protagonist and marketed as Icotyde, is indicated for patients aged 12 years and older who weigh at least 40 kilograms and are eligible for systemic therapy or phototherapy.
Icotyde is notable as the first FDA-approved daily peptide pill designed to target the IL-23 receptor, offering complete skin clearance in patients with plaque psoriasis. This approval introduces a new oral option for patients and places Icotyde in direct competition with Bristol Myers Squibb’s Sotyktu, an oral TYK2 inhibitor that was approved by the FDA in September 2022. Sotyktu has since become a significant revenue driver for Bristol Myers Squibb, generating $291 million worldwide last year—a 19% increase over 2024.
The launch of Icotyde may help Johnson & Johnson address declining sales from its immunology drug Stelara, which has faced biosimilar competition since early last year resulting in a 41% reduction in sales. In response, the company has shifted resources from infectious diseases and vaccines to support its immunology pipeline, including drugs like Tremfya for plaque psoriasis and Simponi for rheumatoid arthritis.
Icotyde’s approval is supported by data from the Phase 3 ICONIC program involving approximately 2,500 patients across four late-stage studies. Results from the ICONIC-LEAD study released in March 2025 showed that 65% of patients taking daily Icotyde achieved clear or almost clear skin at week 16 compared to just 8% of those on placebo. Additional studies demonstrated that Icotyde outperformed both placebo and Sotyktu in clearing skin lesions. Data published later that year in The Lancet reported that 70% of Icotyde-treated patients achieved clear or almost clear skin at week 16 versus only 9% among Sotyktu comparators.
Further research includes ongoing trials such as ICONIC-ASCEND, which compares Icotyde to both placebo and Stelara according to a federal clinical trials database. Johnson & Johnson is also investigating additional uses for Icotyde in conditions such as psoriatic arthritis, ulcerative colitis, and Crohn’s disease.
