Icotrokinra

  Product Detail  

1. Basic Naming & CAS Registry Number

• Generic Name: Icotrokinra (Hydrochloride salt for oral tablet)
• Brand Name: ICOTYDE™
• Research Code: JNJ-77242113 / JNJ-2113
• CAS Number: 2763602-16-8
• Co-developer: Protagonist Therapeutics + Janssen (Johnson & Johnson)
• U.S. FDA Approval Date: March 18, 2026

2. Chemical Classification

3. Mechanism of Action

• Suppresses IL‑23‑driven STAT3 phosphorylation (IC₅₀ = 5.6 pM in human PBMCs)
• Inhibits downstream secretion of key pro-inflammatory cytokines: IL‑17A, IL‑17F, IL‑22, IL‑19
• Specifically targets the IL‑23/Th17 inflammatory axis central to psoriasis and inflammatory bowel disease; no meaningful activity against IL‑12Rβ1, retaining normal IL‑12 immune functionFDA Access...

4. Approved Indication (FDA Label)

1. Adult patients ≥18 years old
2. Adolescents ≥12 years old with body weight ≥40 kg
   
   
   Who qualify for systemic therapy or phototherapy

• Psoriatic arthritis
• Moderately to severely active ulcerative colitis
• Crohn’s disease

5. Approved Dosage & Administration

Standard Strength

Dosing Regimen

• Recommended dose: 200 mg once daily, taken orally with or without food
• Swallow whole tablet; do not split, crush or chew
• No initial dose titration; fixed daily dose for all eligible patients
• No routine laboratory monitoring required before or during treatment

6. Core Clinical Efficacy (Phase 3 ICONIC Trials)

1. Short-term clearance (Week 16): ~70% of patients achieved PASI 90 (90% skin lesion clearance)
2. Long-term durability (Week 52): Sustained high clearance rates for hard-to-treat areas (scalp, genital, palmoplantar psoriasis)
   • 72% scalp psoriasis patients reached clear/almost clear skin
   • 85% genital psoriasis patients achieved complete or near-complete resolutionJohnson & ...
3. Head-to-head data vs injectable IL‑23 mAb (ustekinumab): Superior skin clearance at matched treatment duration
4. Adolescent cohort demonstrated consistent efficacy matching adult populations

7. Pharmacokinetics Highlights

• Linear exposure within therapeutic dose window
• Steady-state plasma concentration reached within 7 days of daily dosing
• Oral bioavailability optimized via proprietary cyclic peptide scaffold from Protagonist’s oral peptide platform
• Minimal systemic immunogenic risk compared to injectable antibody biologics

8. Safety Profile

Most Common Adverse Reactions (≥3%)

Key Safety Advantages

• Overall adverse event rate comparable to placebo (49.1% vs 51.9%)
• No elevated risk of serious infections, malignancy or major cardiovascular events observed in Phase 3 programs
• No injection-site reactions (unique oral route benefit vs IL‑23 injectables)

Contraindications

9. Commercial & Competitive Differentiation

1. First and only oral IL‑23 pathway targeted therapy globally; all prior IL‑23 inhibitors are injectable mAbs
2. Once-daily oral administration greatly improves patient adherence vs subcutaneous injections
3. Selective IL‑23R-only inhibition without disrupting IL‑12-mediated host defense
4. Broad pipeline expansion across dermatology and gastroenterology inflammatory diseases
5. Oral peptide manufacturing delivers simplified supply chain vs complex biologic production

10. Regulatory Global Progress

• U.S. FDA approved March 2026, launched in U.S. pharmacies Q2 2026
• NMPA (China) NDA submitted, accepted for priority review
• Marketing authorization applications planned for EU, UK, South Korea and Southeast Asian markets in 2026–2027