UK regulator approves Icotyde, an oral peptide pill for psoriasis

Britain’s medicines regulator has approved icotrokinra, a psoriasis drug from Johnson & Johnson that is a peptide taken by mouth rather than by injection. The Medicines and Healthcare products Regulatory Agency (MHRA) announced on Oct 23, 2026 that it had authorized icotrokinra hydrochloride, sold as Icotyde, for moderate to severe plaque psoriasis. The UK decision comes about seven months after the US Food and Drug Administration cleared the same drug for the same condition.

What the MHRA approved

According to the regulator, the license covers adults and adolescents aged 12 and older who weigh at least 40 kg and are candidates for systemic therapy, meaning treatment that works throughout the body rather than creams applied to the skin. The authorization was granted on Oct 23 to Janssen-Cilag Limited, the J&J unit that holds the UK license.

The MHRA said the drug works by binding to and blocking the IL-23 receptor. IL-23 is a signaling protein involved in the inflammation behind psoriasis and other immune-mediated diseases. In the agency’s words, “Icotrokinra hydrochloride is taken as a 200mg tablet once a day,” and patients are told to follow the Patient Information Leaflet. The full Summary of Product Characteristics is due on the MHRA Products website within seven days of approval.

Julian Beach, the MHRA’s executive director of operations, said the decision gives “another treatment option for patients living with moderate to severe plaque psoriasis.” He added that the drug’s safety will continue to be closely monitored, and asked patients and clinicians to report suspected side effects through the Yellow Card scheme.

The evidence behind it

The MHRA said its approval was supported by four Phase 3 trials involving 2,500 people with moderate to severe plaque psoriasis, among them 72 adolescents aged 12 to under 18. At week 16, all four studies showed the drug worked better than placebo in the groups studied, the agency said.

J&J has reported more detailed results. In its March press release on the US approval, the company said that in its two head-to-head trials against an active comparator, about 70% of patients had clear or almost clear skin and 55% reached a PASI 90 response, meaning at least a 90% reduction in a standard measure of disease severity, at week 16. EMJ repeated those company figures in its report on the UK decision. These are company-reported numbers; the MHRA’s announcement does not cite them.

US approval and what comes next

The FDA approved Icotyde on March 18, 2026, for moderate to severe plaque psoriasis in adults and in children 12 and older weighing at least 40 kg, J&J said at the time. It was the drug’s first approved use. J&J developed it with Protagonist Therapeutics under a license and collaboration agreement between the two companies.

Reuters, in a report carried by KSL.com, said J&J is also studying icotrokinra in ulcerative colitis, psoriatic arthritis and Crohn’s disease, and expects the drug to reach $5 billion in peak sales across multiple uses. Those other uses are not approved anywhere.

UK approval does not mean patients can get the drug on the National Health Service right away. EMJ reported that NHS availability depends on a technology appraisal by the National Institute for Health and Care Excellence (NICE), which is ongoing, and on later decisions about pricing and reimbursement. Pharmacy Business also reported the approval on Oct 24.

Why an oral peptide stands out

Peptides are short chains of amino acids. Most peptide medicines are injected because the stomach and intestines are full of enzymes that break peptides down, and very little of a swallowed peptide reaches the bloodstream, as a 2025 review in Pharmaceutics describes. J&J calls Icotyde the first and only targeted oral peptide designed to block the IL-23 receptor. EMJ noted that it works in a way similar to biologic psoriasis treatments, which are injected, but comes as a tablet.

What is not known

• When UK patients can get it. NICE has not yet issued guidance, and no NHS price has been announced.
• The full UK product information. The MHRA said the Summary of Product Characteristics and patient leaflet will be posted within seven days of approval; we had not seen them at publication.
• Whether the other uses will succeed. The trials in ulcerative colitis, psoriatic arthritis and Crohn’s disease have not led to an approval.

We will update this story when the MHRA publishes the product information or NICE issues guidance.