Icotrokinra (JNJ2113)

China [CN]

Icotrokinra (JNJ-2113) Key Information

Generic Name: Icotrokinra  Chinese Name: 伊曲白滞素 (Icotrokinra Hydrochloride)  Development Code: JNJ-2113, JNJ-77242113, PN-21235  CAS Number: 2763602-16-8  Drug Type: First-in-class oral macrocyclic peptide IL-23 receptor antagonist  Originator/Collaboration: Protagonist Therapeutics (discovery), Johnson & Johnson (development)

Mechanism of Action

Precise Target: Selectively binds to and blocks the IL-23 receptor (IL-23R), inhibiting the IL-23/IL-17 inflammatory axis

Signal Blockade: Inhibits IL-23-induced STAT3 phosphorylation (IC₅₀=5.6 pM), blocking the expression of downstream pro-inflammatory factors (IL-17A/F, IL-22, IFN-γ)

Oral Advantage: Optimized macrocyclic peptide structure, no injection required, no absorption enhancers needed, achieving systemic exposure and tissue targeting

Core Clinical Applications (2026)

1. Submitted/Priority Review Indications

Moderate to severe plaque psoriasis (PsO): Adults and adolescents ≥12 years old, suitable for systemic treatment/phototherapy

Dosing Regimen: Once daily, oral (Phase III core dose: 400 mg)

Key Phase III (ICONIC-LEAD) Data:

Week 24: 65% of patients achieved IGA 0/1 (clear/almost clear skin), 50% achieved PASI 90, 86.4% achieved IGA 0/1

Adolescent subgroup: 75% achieved IGA 0 (complete clearance)

Safety: Comparable to placebo, mainly mild to moderate gastrointestinal reactions

2. Investigational Indications (Phase II)

Ulcerative colitis (UC): Phase IIb (ANTHEM-UC), 28 weeks, 31.7% clinical remission, 38.1% Endoscopic improvement

Crohn's disease (CD): Phase II clinical trials ongoing