Icotrokinra

Icotrokinra is a peptide that selectively binds to the IL-23 receptor (IL-23R) with a dissociation constant of 7 pM and antagonizes the binding of IL-23. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses.

• ICOTYDE is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is an interleukin-23 (IL-23) receptor antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy.ICD-10: L40.9

• None. None.contraindicated

See the full prescribing information for recommended evaluation and immunizations prior to treatment. ( 2.1 ) Recommended dosage is 200 mg orally once daily. ( 2.2 ) Administer ICOTYDE on an empty stomach with water upon waking. ( 2.2 ) Wait at least 30 minutes after taking ICOTYDE before eating food. ( 2.2 ) For patients who have difficulty swallowing tablets, ICOTYDE can be dispersed in water. ( 2.3 ) 2.1 Recommended Evaluation and Immunizations Prior to Treatment Initiation Consider evaluating patients for tuberculosis (TB) infection prior to initiating treatment with ICOTYDE based on clinical judgment [see Warnings and Precautions (5.2) ] . Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions (5.3) ] . 2.2 Recommended Dosage and Administration Instructions The recommended dosage of ICOTYDE is 200 mg administered orally once daily. Administer ICOTYDE upon waking on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food. Swallow ICOTYDE whole. Do not crush, split, or chew tablets [see Clinical Pharmacology (12.3) ] . If a patient misses a dose, instruct patients to take the missed dose as soon as possible with a return to normal dosing schedule the following day. 2.3 Alternative Preparation and Administration Instructions for Patients Who Have Difficulty Swallowing Tablets ICOTYDE 200 mg tablet can also be dispersed in water using the following instructions: Place one ICOTYDE tablet in a cup containing at least 120 mL (4 ounces) of water.

Infections : Avoid treatment with ICOTYDE in patients with any clinically important active infection until the infection resolves or is adequately treated. If such an infection develops, discontinue ICOTYDE until the infection resolves. ( 5.1 ) Tuberculosis (TB) : Consider evaluating for TB prior to initiating treatment with ICOTYDE based on clinical judgment. Monitor patients for signs and symptoms of active TB during and after treatment with ICOTYDE. ( 5.2 ) Immunizations : Avoid use of live vaccines during treatment with ICOTYDE. ( 5.3 ) 5.1 Infections Medicines that interact with the immune system may increase the risk of infection. In the 16-week placebo-controlled trials in subjects with moderate-to-severe plaque psoriasis, the rate of serious infections for ICOTYDE-treated subjects was 0.2% compared to 0.4% of subjects who received placebo. Avoid treatment with ICOTYDE in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing ICOTYDE. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection and/or is not responding to standard therapy, monitor the patient closely and discontinue ICOTYDE until the infection resolves. 5.2 Tuberculosis Consider evaluating patients for tuberculosis (TB) infection prior to initiating treatment with ICOTYDE based on clinical judgment.

Most common adverse reactions (≥1%) are headache, nausea, cough, fungal infection, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ICOTYDE was evaluated in two placebo-controlled trials (Trial PSO-3 and Trial PSO-4) and two placebo- and active-controlled trials (Trial PSO-1 and Trial PSO-2) [see Clinical Studies (14) ] . A total of 2367 adults and pediatric subjects 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis received ICOTYDE 200 mg orally once daily. Of these, 648 subjects were treated with ICOTYDE for at least one year. Data from these four trials were pooled to evaluate the safety of ICOTYDE compared to placebo for 16 weeks. Adverse Reactions Weeks 0 to 16 Table 1: Adverse Reactions that Occurred in ≥1% of Subjects in the ICOTYDE Group and More Frequently than in the Placebo Group in Trials PSO-1, PSO-2, PSO-3, and PSO-4 through Week 16 percentages based on Cochran-Mantel-Haenszel (CMH) adjusted proportions.

Moderate or Severe Renal Impairment: Monitor for potential adverse reactions when ICOTYDE is used in patients with eGFR <60 mL/min. ( 8.6 ) 8.1 Pregnancy Risk Summary The available data on the use of ICOTYDE during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In an animal reproduction study in rabbits, oral administration of icotrokinra to pregnant rabbits during the period of organogenesis at a dose 157 times the maximum recommended human dose (MRHD) based on AUC comparison resulted in maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There is a pregnancy safety study for ICOTYDE. If a patient becomes pregnant while receiving ICOTYDE, healthcare providers can report ICOTYDE exposure by calling 1-800-526-7736 or visiting www.ICOTYDE.com.

Metabolism

Following the administration of icotrokinra 200 mg, the mean (standard deviation) maximum concentration (C max ) is 3.62 (1.48) ng/mL and total systemic exposure (AUC inf ) is 44.8 (11.4) ng*h/mL. Icotrokinra C max and AUC increase in a dose-proportional manner between 0.05 to 5 times the recommended dosage in healthy subjects.

• Mar 17, 2026NDANDA220149Janssen Biotech

The 4 most recently updated of 4 ClinicalTrials.gov registrations naming Icotrokinra as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
  Recruiting · Phase 2 · Phase 3 · Interventional · 1,092 enrolled · Janssen Research & Development, LLC
  NCT07196722updated 2026-06-05
• A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis
  Recruiting · Phase 3 · Interventional · 750 enrolled · Janssen Research & Development, LLC
  NCT06807424updated 2026-06-05
• A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
  Recruiting · Phase 3 · Interventional · 882 enrolled · Janssen Research & Development, LLC
  NCT07196748updated 2026-06-05
• A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis
  Active not recruiting · Phase 3 · Interventional · 552 enrolled · Janssen Research & Development, LLC
  NCT06878404updated 2026-06-05

Frequently asked questions

How does Icotrokinra work?

Icotrokinra is a peptide that selectively binds to the IL-23 receptor (IL-23R) with a dissociation constant of 7 pM and antagonizes the binding of IL-23. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses.

What is Icotrokinra used for?

According to FDA labeling, Icotrokinra carries indications including: ICOTYDE is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is an interleukin-23 (IL-23) receptor antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Icotrokinra?

Icotrokinra is classified as Interleukin-23 Antagonists, Decreased Cytokine Activity.

What are the brand names for Icotrokinra?

Icotrokinra is marketed under brand names including Icotyde.

What are the contraindications for Icotrokinra?

Icotrokinra labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.