Icotyde

(Icotrokinra)

Phase 3Small molecule

Johnson & Johnson

Icotyde is one of 95 small molecule programs targeting Ulcerative Colitis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Ulcerative ColitisActive, not recruiting

Psoriatic ArthritisActive, not recruiting

Crohn DiseaseRecruiting

Colitis, UlcerativeRecruiting

Arthritis, PsoriaticRecruiting

Ulcerative ColitisPhase 3

Active, not recruiting

Psoriatic ArthritisPhase 3

Active, not recruiting

Crohn DiseasePreclinical

Recruiting

Colitis, UlcerativePhase 3

Recruiting

Arthritis, PsoriaticPhase 3

Recruiting

Competition

Competitive Landscape

460 competitors in Ulcerative Colitis

#DrugCompanyPhaseTrials

Omvoh

Eli Lilly

Phase 3

14 2

Stelara

Johnson & Johnson

Phase 3

12 3

Velsipity

Pfizer

Phase 3

11 4

Orencia

Bristol-Myers Squibb

Phase 3

1 5

Icotyde

Johnson & Johnson

Phase 3

4 6

Diosmin

TTanta University

Phase 3

1 7

JNJ-42756493

ABX464

8 9

Duvakitug

Sanofi

Phase 3

2 10

Asacol

TTillotts Pharma AG

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Phase 3Recruiting

Arthritis, Psoriatic

NCT06807424

Phase 3Active, not recruiting

Psoriatic Arthritis

NCT06878404

Q1 2032

Phase 3Recruiting

Colitis, Ulcerative

NCT07196748

Q4 2032

PreclinicalRecruiting

Crohn Disease

NCT07196722

Clinical

Trials by Indication[1]

Psoriatic Arthritis1 trial

A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06878404·552 enrolled

Arthritis, Psoriatic1 trial

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06807424·750 enrolled

Crohn Disease1 trial

A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT07196722·1,092 enrolled

Colitis, Ulcerative1 trial

A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults With an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT07196748·882 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 17, 2026

ICOTYDE

NDA NDA220149

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Icotrokinra. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Icotrokinra compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Icotrokinra. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA220149). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Icotyde. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Johnson & Johnson

Patent Landscape[5]

Patent Cliff

Jul 12, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12552836Jul 12, 2039

11845808Jan 14, 2041

11939361Nov 19, 2041

Icotyde

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Q1 2032

Q4 2032

Trials by Indication[1]

Psoriatic Arthritis1 trial

Arthritis, Psoriatic1 trial

Crohn Disease1 trial

Colitis, Ulcerative1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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