MHRA approves oral IL-23 drug Icotyde for plaque psoriasis

The UK medicines regulator approved icotrokinra hydrochloride, sold as Icotyde by Janssen-Cilag, a once-daily oral IL-23 receptor blocker for moderate to severe plaque psoriasis in adults and adolescents from age 12.

Why it matters: An oral drug on the IL-23 pathway, until now served mainly by injectables, reaches the UK market the same morning Gilead paid $1.275 billion upfront for a Phase 1 oral IL-23 program, underlining how contested the target has become.

Data as of MHRA approval announcement of October 23, 2026, read in full on GOV.UK (the regulator's own release). Authorisation granted to Janssen-Cilag Limited on October 23, 2026.

The Medicines and Healthcare products Regulatory Agency has approved icotrokinra hydrochloride, sold as Icotyde, for moderate to severe plaque psoriasis in adults and adolescents aged 12 and older who weigh at least 40 kg and are candidates for systemic therapy. The drug is a 200 mg tablet taken once a day and works by selectively blocking the IL-23 receptor, a driver of the chronic inflammation behind immune-mediated diseases such as psoriasis.

The approval rests on four Phase 3 trials covering 2,500 people, including 72 adolescents, in which the drug beat placebo at week 16 in all four studies, the regulator said. Authorisation was granted to Janssen-Cilag Limited on October 23, with the product information to be published on the MHRA Products website within seven days and safety monitoring continuing through the Yellow Card scheme.

MHRA approves oral IL-23 drug Icotyde for plaque psoriasis

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