What is it prescribed for?
ICOTYDE is prescribed for adults and children 12 years of age and older who weigh at least 40 kg and have moderate-to-severe plaque psoriasis that may require systemic therapy or phototherapy. Plaque psoriasis is a long-term immune-related skin disease that causes thick, red, scaly patches that can itch, crack, or become painful. Many patients struggle with symptoms for years and may cycle through creams, injections, or other medicines without achieving clear skin. ICOTYDE is important because it introduces a completely new oral treatment approach that targets one of the main immune pathways involved in psoriasis. The FDA approved ICOTYDE on March 17, 2026.
What is the name of the drug and what does it do?
The medication is ICOTYDE™ (icotrokinra), a once-daily oral tablet. It is the first FDA-approved targeted oral peptide designed to block the interleukin-23 (IL-23) receptor, an important driver of inflammation in psoriasis. Unlike many psoriasis biologics that require injections, ICOTYDE is taken by mouth, which may make treatment easier for some patients. The medicine is designed to reduce skin inflammation, improve skin clearance, and help control symptoms over time.
How does it work?
ICOTYDE works by selectively blocking the IL-23 receptor on immune cells. IL-23 is a protein that plays a major role in the inflammation that causes psoriasis plaques to form.
By blocking this pathway, ICOTYDE helps:
- Reduce inflammation in the skin
- Slow the overproduction of skin cells
- Improve redness, scaling, and itching
This targeted approach helps calm the immune system without broadly suppressing it. ICOTYDE is also notable because it is a peptide medicine taken orally rather than by injection.
What did the research discover?
ICOTYDE was studied in several large Phase 3 clinical trials involving about 2,500 patients with plaque psoriasis. In these studies, many patients achieved major skin improvement after 16 weeks of treatment.
Researchers found:
- About 70% of some patients achieved clear or almost clear skin
- More than half achieved at least 90% improvement in psoriasis severity scores
- Benefits continued with longer treatment
In some head-to-head studies, ICOTYDE outperformed another oral psoriasis medication called deucravacitinib. These findings supported FDA approval and highlighted the drug’s potential as a first-line systemic therapy.
What are some of the side effects?
The most common side effects included:
- Headache
- Nausea
- Cough
- Fungal infections
- Fatigue
Because ICOTYDE affects the immune system, infections are an important safety concern. Patients should avoid starting treatment during serious active infections. Tuberculosis evaluation and routine vaccinations may also be recommended before treatment begins.
What are the dosage recommendations and how is it prescribed?
The recommended dose of ICOTYDE is 200 mg taken by mouth once daily. It should be taken:
- Upon waking
- On an empty stomach
- With water
- At least 30 minutes before eating food
The tablet should be swallowed whole, although special instructions are available for patients who have trouble swallowing tablets. If a dose is missed, patients should take it as soon as possible and then return to the regular schedule the next day.
Source:
ICOTYDE™ (icotrokinra) tablets, for oral use [prescribing information]. Horsham (PA): Janssen Biotech, Inc.; 2026. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220149Orig1s000lbl.pdf. Accessed by: June 6, 2026.
