KarX-EC

Phase 3Small molecule

KarX-EC is one of 42 small molecule programs targeting Irritability Associated With Autism Spectrum Disorder. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Irritability Associated With Autism Spectrum DisorderNot yet recruiting

Alzheimer DiseaseRecruiting

Irritability Associated With Autism Spectrum DisorderPhase 3

Not yet recruiting

Alzheimer DiseasePhase 3

Recruiting

Competition

Competitive Landscape

100 competitors in Alzheimer Disease

#DrugCompanyPhaseTrials

Dayvigo

Eisai

Approved

1 2

Leqembi

Eisai

Approved

1 3

Avelox

Victoza

Avandia

Estrace

Rifadin

Aleve

Epidiolex

Cialis

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

Timeline

Expected Milestones

Q1 2028

Phase 3Recruiting

Alzheimer Disease

NCT06947941

Q1 2029

Phase 3Recruiting

Alzheimer's Disease

NCT06976203

Phase 3Recruiting

Alzheimer's Disease

NCT06976216

Q3 2029

Phase 3Recruiting

Alzheimer Disease

NCT06937229

Phase 3Not yet recruiting

Irritability Associated With Autism Spectrum Disorder

NCT07285798

Phase 3Not yet recruiting

Irritability Associated With Autism Spectrum Disorder

NCT07284745

Clinical

Trials by Indication[1]

Alzheimer's Disease2 trials

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated With Mild to Moderate Alzheimer's Disease (MINDSET 2)

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06976203·586 enrolled

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06976216·586 enrolled

Alzheimer disease2 trials

A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06937229·650 enrolled

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Psychosis Associated With Alzheimer's Disease

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06947941·325 enrolled

Irritability Associated With Autism Spectrum Disorder2 trials

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder

Not yet recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT07285798·176 enrolled

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder

Not yet recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT07284745·176 enrolled

Elderly Participants1 trial

A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Xanomeline With Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity and to Assess the Effect of Omeprazole on the PK of Xanomeline With Trospium Chloride in Healthy Adult Participants

Completed·KKaruna Therapeutics·Phase 1·NCT06605950·78 enrolled

Psychiatric Disorder1 trial

Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06853171·24 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for KarX-EC. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — KarX-EC compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for KarX-EC. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Bristol-Myers Squibb

KarX-EC

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Q1 2029

Q3 2029

Trials by Indication[1]

Alzheimer's Disease2 trials

Alzheimer disease2 trials

Irritability Associated With Autism Spectrum Disorder2 trials

Elderly Participants1 trial

Psychiatric Disorder1 trial

References

Drug Info

Quick Facts

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