Icotrokinra
icotrokinra
FILED
Drug Profile
ModalityPeptide
RouteOral
Therapy AreaImmunology
Peak Sales Est$8000M
Formulations[{"id":"icotrokinra-oral","doses":"25mg (expected)","route":"Oral","device":"Tablet","setting":"PATI
Companies
JNJ (LICENSEE)100%
Mechanism: IL-23 receptor antagonist (oral peptide)
Expert: Synthetic constrained peptide targeting IL-23R with picomolar affinity (KD 7.1 pM). Blocks IL-23-induced STAT3 phosphorylation (IC50 5.6 pM). Oral bioavailability via engineered GI stability. Selective for IL-23R; does not inhibit IL-12 signaling via IL-12Rbeta1.
Everyday: A small engineered protein taken as a daily pill that blocks the IL-23 receptor on immune cells. Same target as injectable IL-23 drugs like Skyrizi, but delivered orally. First oral drug to approach injectable-level efficacy in psoriasis.
Targets: []
Programs (1)
| Indication | Stage | Key Study | Regional Status |
|---|
| Mod-sev PsO | FILED | ICONIC-LEAD | [{"stage":"FILED","region":"US","filing_date":"2025-07-01"},{"stage":"FILED","re |
Clinical Studies (2)
Primary EP: [{"id":"iga01-w16","name":"IGA 0/1 at Week 16","type":"PRIMARY","unit":"%","results":[{"value":64.7,"arm_id":"ico-arm","p_value":0.001,"vs_placebo":"vs placebo"},{"value":8.3,"arm_id":"pbo-arm"}],"tim
Primary EP: [{"id":"iga01-w16","name":"IGA 0/1 at Week 16","type":"PRIMARY","unit":"%","results":[{"value":68,"arm_id":"ico-arm","p_value":0.001,"vs_placebo":"vs deucravacitinib"},{"value":50,"arm_id":"deuc-arm"}
Upcoming Catalysts (1)
Icotrokinra - Mod-sev PsO - FDA PDUFA Decision
Q2 2026 (est. April-June 2026)
Notes
First-in-class oral IL-23R antagonist peptide. Discovered by Protagonist Therapeutics (PTGX), licensed to JNJ. Trade name: Icotyde. Codes: JNJ-77242113, JNJ-2113. NDA filed Jul 2025 (PsO, adults+adolescents 12+). PDUFA mid-2026. ICONIC-LEAD: 65% IGA 0/1 Wk16, 84% PASI 90 Wk52. ICONIC-ADVANCE 1&2: beat Sotyktu H2H (~70% vs ~52% IGA 0/1). Also Ph3 PsA, Ph3 UC, Ph2b/3 CD. Placebo-like safety. Could disrupt psoriasis biologic market with IL-23 efficacy in pill form. Est. peak >$8B multi-indication.
Data from Supabase · Updated 2026-03-24