Icotyde, co-developed by Johnson & Johnson and Protagonist Therapeutics, is backed by data from the Phase 3 ICONIC program, which, among other advantages, showed significant superiority over Bristol Myers Squibb’s Sotyktu.
The FDA has approved Johnson & Johnson’s IL-23 receptor blocker icotrokinra for moderate-to-severe plaque psoriasis. The drug, co-developed with Protagonist, will carry the brand name Icotyde.
Icotyde will be available for use in patients aged 12 years and older who weigh at least 40 kg and who are eligible for systemic therapy or phototherapy. Icotyde is the first FDA-approved daily peptide pill designed to target the IL-23 receptor that provides complete skin clearance in patients with plaque psoriasis, according to the pharma’s news release on Wednesday,
With the approval, Icotyde will compete with Bristol Myers Squibb’s oral TYK2 inhibitor Sotyktu, which enjoys more than a three-year lead after winning the FDA’s go-ahead in September 2022. Sotyktu has since become a strong growth driver for BMS, bringing in $291 million worldwide last year, a 19% jump over 2024.
Icotyde’s arrival could also help J&J better sustain the loss of exclusivity of its immunology blockbuster Stelara. Biosimilar threats to the product entered the market early last year, contributing to a 41% reduction in sales. The pharma has so far managed well, cutting back spending in infectious diseases and vaccines to divert resources into its immunology pipeline, supporting the development of newer drugs like the plaque psoriasis biologic Tremfya and the rheumatoid arthritis therapy Simponi.
Icotyde’s approval was backed by data from the Phase 3 ICONIC program, which spans four late-stage studies enrolling some 2,500 patients. A data drop from the Phase 3 ICONIC-LEAD study in March 2025 showed that 65% of patients on daily Icotyde achieved clear or almost clear skin at week 16, as compared with 8% of placebo comparators. Icotyde also bested placebo in terms of disease severity.
At the time, J&J also dropped simultaneous readouts from the ICONIC-ADVANCE 1 and 2 studies, demonstrating that Icotyde not only outperformed placebo in terms of clearing skin lesions but also bested BMS’ Sotyktu. Subsequent data published later that year in The Lancet showed that 70% of Icotyde-treated patients achieved clear or almost clear skin at 16 weeks, versus 9% is Sotyktu comparators.
J&J also filed data from the ICONIC-ASCEND study, which compared Icotyde to placebo and the pharma’s own Stelara. The trial is still ongoing, according to a federal clinical trials database.
J&J is also testing Icotyde in other indications, including psoriatic arthritis, ulcerative colitis and Crohn’s disease.
