Icotrokinra

FDA-approved context Immune Support 2 sources

Icotrokinra (also known as JNJ-2113) is a first-in-class, orally bioavailable macrocyclic peptide that selectively targets and blocks the interleukin-23 (IL-23) receptor. Research and clinical trials have demonstrated its high efficacy in treating moderate-to-severe plaque psoriasis, offering a targeted oral alternative to traditional injectable biologics.

01Dosing reference

Amount

200 mg

Frequency

Once daily

Cycle

Continuous daily use as prescribed

Reference figures, not a recommendationThese values reflect amounts described in the literature and vendor documentation this database indexes. Use the reconstitution calculator to convert them into syringe units.

02Mechanism of action

IL-23 Receptor Binding

Icotrokinra selectively binds to the IL-23 receptor with high affinity, acting as an antagonist.

Pathway Inhibition

It blocks the intracellular signaling of IL-23, preventing the downstream activation of the Th17 inflammatory pathway.

Inflammation Reduction

This leads to a significant decrease in the production of pro-inflammatory cytokines like IL-17A, reducing skin inflammation and plaque formation.

03Human evidence

Demonstrated high rates of durable skin clearance in patients with moderate-to-severe plaque psoriasis.

Large-scale Phase 3 human clinical trials evaluating oral administration, showing significant improvement in PASI scores compared to placebo.

Showed positive results and durable skin clearance in difficult-to-treat areas like the scalp and genitals.

Phase 2b and Phase 3 clinical studies assessing long-term efficacy and safety in specific psoriasis manifestations.

04Preclinical evidence

Dose-dependent inhibition of IL-23-induced IL-17A production in blood.

In vivo rat models demonstrating robust systemic IL-23 pathway inhibition upon oral dosing.

Attenuated signs of disease in inflammatory bowel disease models.

Preclinical rat colitis models showing potential efficacy for other IL-23 mediated conditions beyond psoriasis.

05What is known vs. unknown

Reasonably established

It is the first targeted oral peptide designed to precisely block the IL-23 receptor.
FDA-approved under the brand name ICOTYDE for moderate-to-severe plaque psoriasis in adults and adolescents.
Offers an oral alternative to traditional injectable monoclonal antibodies targeting the IL-23 pathway.
Demonstrates high selectivity and potency, with single-digit picomolar affinity for the IL-23 receptor.

Unknowns & limits

Long-term safety data beyond the clinical trial periods is still being collected in post-marketing surveillance.
Its efficacy in other IL-23 mediated conditions, such as inflammatory bowel disease or psoriatic arthritis, is still under active clinical investigation.

06Safety & regulatory context

Regulatory statusIcotrokinra is FDA-approved (under the brand name ICOTYDE) for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older. It has demonstrated a favorable safety profile in clinical trials, with common adverse events being generally mild to moderate. As an immunosuppressive agent targeting the IL-23 pathway, there may be an increased risk of infections. It is a prescription medication and must be used under medical supervision.

07Compared with Guselkumab (Tremfya)

Icotrokinra vs. Guselkumab (Tremfya)

Key difference

Guselkumab is an injectable monoclonal antibody that binds to the IL-23 cytokine itself, whereas icotrokinra is an oral macrocyclic peptide that blocks the IL-23 receptor.

When researchers discuss each

Researchers discuss guselkumab when evaluating established injectable biologics for psoriasis, and icotrokinra when exploring novel, patient-friendly oral peptide therapies with similar targeted mechanisms.

08Glossary

Interleukin-23 (IL-23)

A protein that plays a key role in the immune system's inflammatory response, particularly in autoimmune diseases like psoriasis.

Macrocyclic peptide

A type of protein molecule with a ring-like structure that makes it more stable and capable of being absorbed orally.

Plaque psoriasis

A chronic autoimmune condition characterized by raised, red, scaly patches on the skin.

09Knowledge check

Q1What is the primary mechanism of action of icotrokinra?

Q2What is a major advantage of icotrokinra compared to traditional IL-23 inhibitors?

Q3Based on the dossier's preclinical findings and stated limitations, which conclusion about icotrokinra's potential in inflammatory bowel disease (IBD) is best supported?

Q4Which statement best reflects the dossier's stated comparison between icotrokinra and guselkumab?

Q5Which regulatory and safety statement about icotrokinra is accurate according to the dossier?

10Sources

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Research and educational use onlyNothing on this site is medical advice, a prescription, or a recommendation for human use. Compounds documented here are research chemicals. Consult a qualified clinician before making any health decision.