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UK approves first daily pill blocking the IL-23 psoriasis signal

The MHRA has approved Icotyde for moderate to severe plaque psoriasis from age 12, after trials in which it beat placebo and an existing oral psoriasis pill.

An arm covered with red, scaly plaque psoriasis
Photo: MediaJet · CC BY-SA 3.0
Contents
  1. What the MHRA approved
  2. How icotrokinra works
  3. The ICONIC trial programme
  4. Results against placebo
  5. Results against another pill
  6. Safety
  7. Who it is for
  8. UK and EU access
  9. What happens next

The MHRA approved Icotyde (icotrokinra) on 23 October 2026 for moderate to severe plaque psoriasis in adults and in adolescents aged 12 and over who weigh at least 40 kg. It is a 200 mg tablet taken once a day.

Icotrokinra is the first oral peptide designed to block the IL-23 receptor. Until now, the medicines that target the IL-23 pathway in psoriasis, such as guselkumab, risankizumab and tildrakizumab, have all been injections. A daily pill that reaches similar targets gives people another choice, especially those who would prefer to avoid injections.

The US FDA approved Icotyde in March 2026. NICE is appraising it for the NHS in England but has not yet published guidance.

What the MHRA approved

According to the MHRA:

Item Detail
Medicine Icotrokinra hydrochloride (Icotyde), from Janssen, part of Johnson & Johnson
Use Moderate to severe plaque psoriasis in adults and adolescents aged 12 and over weighing at least 40 kg who are candidates for systemic therapy
Dose One 200 mg tablet once a day
Evidence Four phase 3 trials involving 2,500 people, including 72 adolescents

The MHRA says all four studies showed icotrokinra worked better than placebo at week 16.

Julian Beach, the MHRA's Executive Director, Operations, said: "Today's authorisation provides another treatment option for patients living with moderate to severe plaque psoriasis."

How icotrokinra works

IL-23 is a signalling protein that drives part of the immune response behind psoriasis plaques. Injected antibodies such as guselkumab block IL-23 itself. Icotrokinra takes a different route: it binds the IL-23 receptor on immune cells, so the signal cannot get through.

It is a peptide, a short chain of amino acids, engineered to survive the gut and be absorbed when swallowed. Johnson & Johnson discovered it with Protagonist Therapeutics.

The ICONIC trial programme

The phase 3 programme, called ICONIC, included:

Trial Design
ICONIC-LEAD Icotrokinra against placebo in adults and adolescents with moderate to severe plaque psoriasis
ICONIC-TOTAL Icotrokinra against placebo in people with psoriasis in hard-to-treat areas such as the scalp, genitals, hands and feet
ICONIC-ADVANCE 1 and 2 Icotrokinra against placebo and against deucravacitinib, an existing oral psoriasis pill

Psoriasis trials use two main scores. The Investigator's Global Assessment (IGA) rates the skin from 0 (clear) to 4 (severe); IGA 0/1 means clear or almost clear. PASI 90 means at least a 90% improvement in the Psoriasis Area and Severity Index, which combines how much skin is affected with how red, thick and scaly the plaques are.

Results against placebo

In ICONIC-LEAD, Johnson & Johnson reported that at week 16:

  • 64.7% on icotrokinra reached IGA 0/1, against 8.3% on placebo
  • 49.6% reached PASI 90, against 4.4% on placebo

By week 24, 74.1% on icotrokinra reached IGA 0/1 and 64.9% reached PASI 90. Treatment-emergent adverse events at week 16 were similar: 49.3% on icotrokinra and 49.1% on placebo.

ICONIC-TOTAL also met its primary endpoint of IGA 0/1 at week 16 against placebo, according to the company.

Results against another pill

The head-to-head data matter most for prescribers. Deucravacitinib is a once-daily TYK2 inhibitor already used for psoriasis.

According to Johnson & Johnson's medical information summary of ICONIC-ADVANCE 1 and 2, at week 16:

Measure Icotyde against deucravacitinib
IGA 0/1 68% against 50% in ADVANCE 1, and 71% against 55% in ADVANCE 2
Completely clear skin (IGA 0) 37% against 16%, and 37% against 18%
PASI 100 31% against 11%, and 32% against 14%

All of these differences were statistically significant. Through week 24, 58% on icotrokinra and 66% on deucravacitinib reported at least one adverse event. Serious adverse events occurred in 3% in each group.

The trials did not compare icotrokinra with injected IL-23 or IL-17 antibodies, so it is not possible to say from these data whether the pill works as well as the strongest injections.

Safety

The MHRA notice does not list specific side effects; it points patients to the leaflet and the Yellow Card scheme. In the trials, overall adverse event rates were similar to placebo and lower than with deucravacitinib. As with any new medicine, the MHRA will keep monitoring safety, and rarer problems may only appear with wider use.

Who it is for

The licence covers people who are candidates for systemic therapy. In UK practice that usually means psoriasis that is extensive, severe or has a large impact on daily life, and that has not responded well enough to creams, ointments and light therapy.

The adolescent indication is notable. Only 72 adolescents took part across the trials, so the evidence base in that group is smaller.

UK and EU access

In England, NICE is running a single technology appraisal (ID6579) of icotrokinra for people aged 12 and over. Its scope lists deucravacitinib among the comparators. No publication date or price has been announced.

In the EU, we found no European Commission decision at the time of writing.

In the US, the FDA approved Icotyde on 17 March 2026.

Until NICE reports, NHS use in England is unlikely to be routine. Private prescribing may be possible once the medicine is launched in the UK.

What happens next

Johnson & Johnson is testing icotrokinra in psoriatic arthritis through the ICONIC-PsA programme, and has reported two-year data in plaque psoriasis. NICE's draft guidance will be the next UK milestone.

People interested should raise it with their dermatologist.

This article explains published research and isn't medical advice. Talk to your own doctor or specialist team before changing any treatment.

Frequently asked questions

What is Icotyde?

Icotyde (icotrokinra) is a once-daily 200 mg tablet that blocks the IL-23 receptor. It is approved in the UK for moderate to severe plaque psoriasis in people aged 12 and over weighing at least 40 kg.

How well does it work?

In ICONIC-LEAD, 64.7% reached clear or almost clear skin at week 16 against 8.3% on placebo. In ICONIC-ADVANCE 1 and 2 it beat deucravacitinib on the same measure.

Is it safer than injections?

There are no head-to-head trials against injected biologics. In trials, adverse event rates were similar to placebo.

Can I get it on the NHS?

Not routinely yet. NICE is appraising it and has not published guidance.

Is it approved elsewhere?

The FDA approved it in March 2026. We found no EU decision at the time of writing.

Sources

  1. MHRA approves new oral treatment for moderate to severe plaque psoriasis. GOV.UK (MHRA), 2026-10-23
  2. Icotrokinra Phase 3 topline results (ICONIC-LEAD). Johnson & Johnson, 2024-11-18
  3. ICOTYDE comparison to deucravacitinib in the treatment of plaque psoriasis. Johnson & Johnson Medical Connect
  4. Icotrokinra for treating moderate to severe plaque psoriasis in people 12 years and over [ID6579]. NICE
  5. Drug Trials Snapshots: ICOTYDE. US Food and Drug Administration
  6. NCT06095115 on ClinicalTrials.gov. ClinicalTrials.gov
  7. NCT06143878 on ClinicalTrials.gov. ClinicalTrials.gov
  8. NCT06220604 on ClinicalTrials.gov. ClinicalTrials.gov

Medical disclaimer: For information only, not medical advice. Speak to a qualified healthcare professional about your care.

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