MEDISEARCHER NEWS
United Kingdom · Psoriasis · 26 October 2026
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Icotyde (icotrokinra hydrochloride), a once-daily tablet for adults and adolescents with moderate-to-severe plaque psoriasis who are candidates for systemic treatment.
The approval is particularly notable because icotrokinra selectively blocks the interleukin-23 (IL-23) receptor. Injectable medicines targeting the IL-23 pathway are already important psoriasis treatments, but Icotyde brings targeted IL-23 therapy into an oral medicine.
For patients who would prefer a tablet to injections, that could make Icotyde an important new option. However, regulatory approval does not mean that the medicine is automatically available through the NHS. Pricing, reimbursement and NHS access are separate decisions.
In brief
- The MHRA authorised Icotyde (icotrokinra hydrochloride) in the UK on 23 October 2026.
- It is approved for adults and adolescents aged 12 years and older who weigh at least 40 kg and have moderate-to-severe plaque psoriasis requiring systemic treatment.
- Icotyde is a 200 mg tablet taken once daily.
- It selectively blocks the IL-23 receptor, a pathway involved in the inflammation that drives psoriasis.
- The approval was supported by four Phase III trials involving around 2,500 patients.
- In the published ICONIC-LEAD Phase III trial, 65% of patients taking icotrokinra achieved clear or almost-clear skin at week 16, compared with 8% receiving placebo.
- UK regulatory approval does not by itself guarantee routine NHS access.
What has the UK approved?
The MHRA has authorised Icotyde for moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older who weigh at least 40 kg and are candidates for systemic therapy.
Systemic treatments are medicines that work throughout the body rather than treatments such as creams and ointments applied directly to affected skin.
They are generally considered when psoriasis is sufficiently extensive or severe, significantly affects quality of life, involves difficult areas of the body, or has not been adequately controlled with topical treatments and other approaches.
Icotyde contains icotrokinra hydrochloride and is taken as a 200 mg tablet once daily.
Why is Icotyde different from existing psoriasis treatments?
The important difference is the combination of its targeted mechanism and oral administration.
Interleukin-23 is a signalling protein involved in immune and inflammatory responses. The IL-23 pathway plays an important role in the persistent inflammation associated with plaque psoriasis.
Several highly effective psoriasis biologics already target IL-23 or related inflammatory pathways, but these medicines are administered by injection.
Icotrokinra is a targeted oral peptide that selectively binds to and blocks the IL-23 receptor.
That gives patients an oral treatment aimed directly at a pathway already established as an important therapeutic target in psoriasis.
How effective is icotrokinra?
The MHRA said its decision was supported by four Phase III clinical trials involving approximately 2,500 people with moderate-to-severe plaque psoriasis, including adolescents.
One of the pivotal studies, ICONIC-LEAD, was a randomized, double-blind Phase III trial involving 684 adults and adolescents.
Participants received either icotrokinra 200 mg once daily or placebo.
At week 16:
- 65% of patients receiving icotrokinra achieved an Investigator’s Global Assessment (IGA) score indicating clear or almost-clear skin, compared with 8% receiving placebo;
- 50% achieved PASI 90 — at least a 90% improvement in the Psoriasis Area and Severity Index — compared with 4% receiving placebo;
- 33% had completely clear skin according to the IGA measure, compared with 1% receiving placebo; and
- 27% achieved PASI 100, representing complete clearance according to that measure, compared with less than 1% receiving placebo.
The differences between icotrokinra and placebo were statistically significant.
What about psoriasis affecting the scalp, hands, feet or genitals?
These areas can be particularly difficult to treat and can have a disproportionate effect on everyday life even when the total area of affected skin is relatively limited.
The Phase III development programme therefore included a dedicated study of people with psoriasis affecting high-impact sites including the scalp, genital area, hands and feet.
This is relevant because treatment success in plaque psoriasis is not determined only by how much skin is affected. The location of plaques can substantially affect pain, mobility, work, relationships and quality of life.
What are the side effects of Icotyde?
In the published ICONIC-LEAD Phase III trial, 49% of patients receiving icotrokinra and 49% receiving placebo experienced at least one adverse event through week 16.
The most frequently reported adverse events in both groups were nasopharyngitis and upper respiratory tract infections.
The European Medicines Agency’s assessment of the broader clinical programme concluded that Icotyde was generally well tolerated. Fungal infections were among the identified side effects.
As with any newly authorised medicine, safety monitoring continues after approval. The MHRA encourages patients and healthcare professionals to report suspected adverse reactions through the UK’s Yellow Card system.
Is Icotyde a biologic?
Icotyde is described as a targeted oral peptide rather than an injectable monoclonal-antibody biologic.
That distinction is important for patients because many of the highly targeted treatments that transformed moderate-to-severe psoriasis care over the past two decades require injections.
Icotyde provides targeted inhibition of the IL-23 pathway in tablet form.
It is not, however, the first oral systemic medicine available for psoriasis. Other oral treatments use different mechanisms. The innovation is specifically its oral targeting of the IL-23 receptor.
Who could be prescribed Icotyde in the UK?
The marketing authorisation covers adults and adolescents aged 12 years and older weighing at least 40 kg who have moderate-to-severe plaque psoriasis and are candidates for systemic therapy.
That does not mean every patient meeting the wording of the licence will automatically receive Icotyde.
Individual treatment decisions depend on factors including psoriasis severity, previous treatments, other medical conditions, contraindications, patient preference and national or local prescribing policies.
For NHS patients, recommendations from the National Institute for Health and Care Excellence (NICE) and subsequent commissioning arrangements can also determine how a newly licensed medicine is used in practice.
Is Icotyde available on the NHS?
MHRA approval and NHS availability are not the same thing.
The MHRA decides whether a medicine meets the required standards of quality, safety and efficacy and can be marketed in the UK.
NICE separately evaluates whether treatments should be routinely funded by the NHS, taking into account clinical effectiveness and cost effectiveness.
Patients should therefore not assume that the 23 October authorisation means Icotyde can immediately be obtained through routine NHS prescribing.
The practical access position will become clearer as health-technology assessment, pricing and reimbursement decisions progress.
Icotyde is already authorised in the European Union
The UK decision follows an EU-wide marketing authorisation for Icotyde issued by the European Commission on 18 September 2026.
The European indication similarly covers adults and adolescents aged 12 years and older weighing at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
The European Medicines Agency highlighted Icotyde as the first authorised oral medicine targeting the IL-23 pathway.
However, EU marketing authorisation does not mean access is identical across Europe. Decisions about price and reimbursement are generally made within individual member states and can therefore vary considerably between countries.
Why the approval matters for patients
Moderate-to-severe plaque psoriasis is a chronic immune-mediated condition, and patients may require systemic treatment for many years.
Modern injectable biologics can achieve very high levels of skin clearance, but injections are not every patient’s preferred way of taking long-term treatment.
Existing oral systemic medicines provide alternatives, but they work through different biological mechanisms and have differing efficacy and safety profiles.
Icotyde therefore occupies an interesting position: an oral medicine targeting the IL-23 pathway while producing substantial levels of skin clearance in Phase III trials.
The UK approval establishes that option from a regulatory perspective. The next important question for UK patients is how the medicine will be assessed for NHS use and where it will ultimately sit within the existing psoriasis treatment pathway.
Reviewed by: Dr Mattias Hagman, PhD
Editorial review: This article was reviewed for regulatory accuracy, clinical-trial evidence and the distinction between UK marketing authorisation and NHS access.
Last reviewed: 26 October 2026
Sources and verification
MediSearcher reviewed the following primary and authoritative sources when preparing this article:
- Medicines and Healthcare products Regulatory Agency — MHRA approves new oral treatment for moderate to severe plaque psoriasis
- European Medicines Agency — Icotyde European Public Assessment Report
- European Medicines Agency — First oral medicine targeting interleukin-23 receptor recommended for plaque psoriasis
- New England Journal of Medicine — Oral Icotrokinra for Plaque Psoriasis in Adults and Adolescents
This article is for general informational purposes only and is not medical advice. Psoriasis treatment depends on disease severity, previous treatment, other medical conditions and individual circumstances. Patients should discuss treatment options with their doctor or specialist.