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Kawasaki Disease

3
Pipeline Programs
7
Companies
10
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
1
1
0
1
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
267%
Monoclonal Antibody
133%
+ 7 programs with unclassified modality

Competitive Landscape

7 companies ranked by most advanced pipeline stage

UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
1
IVIGPhase 31 trial
Active Trials
NCT04078568Completed3,208Est. Nov 2025
Sandoz
SandozAustria - Kundl
1 program
1
CanakinumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT02980263Withdrawn0Est. Nov 2017
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
1 program
1
AtorvastatinPhase 1/2Small Molecule1 trial
Active Trials
NCT01431105Completed34Est. Jul 2018
Lantheus Medical Imaging
2 programs
Technetium Tc99m SestamibiPHASE_1_21 trial
SestamibiPHASE_31 trial
Active Trials
NCT00162045Completed79Est. Jun 2007
NCT00162032Completed445Est. Dec 2010
Swedish Orphan Biovitrum
2 programs
AnakinraPHASE_21 trial
ANAKINRAPHASE_31 trial
Active Trials
NCT02390596Completed16Est. Feb 2019
NCT04656184Recruiting84Est. Mar 2027
GC Biopharma
GC BiopharmaKorea - Yongin
2 programs
Immunoglobulin GPHASE_41 trial
immunoglobulin GPHASE_41 trial
Active Trials
NCT04003844Completed45Est. Nov 2019
NCT01524939Completed45Est. Sep 2012
Bristol Myers Squibb
1 program
pravastatinPHASE_2Small Molecule1 trial
Active Trials
NCT00305201Withdrawn0Est. May 2007

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
GC BiopharmaImmunoglobulin G
GC Biopharmaimmunoglobulin G
Swedish Orphan BiovitrumANAKINRA
UNION therapeuticsIVIG
Lantheus Medical ImagingSestamibi
SandozCanakinumab
Swedish Orphan BiovitrumAnakinra
Bristol Myers Squibbpravastatin
Colorado TherapeuticsAtorvastatin
Lantheus Medical ImagingTechnetium Tc99m Sestamibi

Clinical Trials (10)

Total enrollment: 3,956 patients across 10 trials

NCT04003844GC BiopharmaImmunoglobulin G

Study of Combined Therapy IVIG-SN 10% and Acetylsalicylic Acid in Kawasaki Disease

Start: Feb 2019Est. completion: Nov 201945 patients
Phase 4Completed
NCT01524939GC Biopharmaimmunoglobulin G

Study of Combined Therapy of Aspirin and "IVIG-SN" in Kawasaki Disease

Start: Jan 2012Est. completion: Sep 201245 patients
Phase 4Completed
NCT04656184Swedish Orphan BiovitrumANAKINRA

A Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin (IVIG) Retreatment, in Patients With Kawasaki Disease Who Failed to Respond to Initial Standard IVIG Treatment

Start: Oct 2023Est. completion: Mar 202784 patients
Phase 3Recruiting
NCT04078568UNION therapeuticsIVIG

Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease

Start: Jan 2020Est. completion: Nov 20253,208 patients
Phase 3Completed
NCT00162032Lantheus Medical ImagingSestamibi

A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease

Start: Aug 2005Est. completion: Dec 2010445 patients
Phase 3Completed
NCT02980263SandozCanakinumab

Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease

Start: Nov 2016Est. completion: Nov 20170
Phase 2Withdrawn
NCT02390596Swedish Orphan BiovitrumAnakinra

Anakinra and Kawasaki Disease

Start: Feb 2016Est. completion: Feb 201916 patients
Phase 2Completed
NCT00305201Bristol Myers Squibbpravastatin

Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease

Start: Apr 2006Est. completion: May 20070
Phase 2Withdrawn
NCT01431105Colorado TherapeuticsAtorvastatin

Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities

Start: Jul 2012Est. completion: Jul 201834 patients
Phase 1/2Completed
NCT00162045Lantheus Medical ImagingTechnetium Tc99m Sestamibi

A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects

Start: Jan 2005Est. completion: Jun 200779 patients
Phase 1/2Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 3,956 patients
7 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.