KarX-EC

Phase 3Small molecule

Bristol-Myers Squibb

KarX-EC is one of 201 small molecule programs targeting Psychiatric Disorder. It is currently in Phase 3.

Indications

Total Trials

Active Trials

200

Competitors

Pipeline

Status by Indication[3][1]

Indication

Psychiatric DisorderActive, not recruiting

Cognitive ImpairmentActive, not recruiting

Alzheimer DiseaseRecruiting

PsychosisActive, not recruiting

Autism Spectrum DisorderActive, not recruiting

IrritabilityActive, not recruiting

Alzheimer's DiseaseRecruiting

Irritability Associated With Autism Spectrum DisorderNot yet recruiting

Psychiatric DisorderPhase 1

Active, not recruiting

Cognitive ImpairmentPhase 3

Active, not recruiting

Alzheimer DiseasePhase 3

Recruiting

PsychosisPhase 3

Active, not recruiting

Autism Spectrum DisorderPhase 3

Active, not recruiting

IrritabilityPhase 3

Active, not recruiting

Alzheimer's DiseasePhase 3

Recruiting

Irritability Associated With Autism Spectrum DisorderPhase 3

Not yet recruiting

Competition

Competitive Landscape

279 competitors in Cognitive Impairment

#DrugCompanyPhaseTrials

Actos

Takeda

Phase 3

3 2

Farxiga

AstraZeneca

Phase 3

1 3

Provigil

NNuvo Research GmbH

Phase 3

1 4

Xarelto

WWim Janssens

Phase 3

1 5

Aquasol E

NNational Eye Institute (NEI)

Phase 3

1 6

Viagra

VViatris Specialty LLC

Phase 3

1 7

Donepezil Hydrochloride

Eisai

Phase 3

3 8

Statins

Sanofi

Phase 3

1 9

KarX-EC

Bristol-Myers Squibb

Phase 3

8 10

Galantamine Hydrobromide

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Phase 3

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 3Not yet recruiting

Irritability Associated With Autism Spectrum Disorder

NCT07284745

Phase 3Recruiting

Alzheimer Disease

NCT06937229

Phase 3Not yet recruiting

Irritability Associated With Autism Spectrum Disorder

NCT07285798

Clinical

Trials by Indication[1]

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

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

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

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

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 disease2 trials

Irritability Associated With Autism Spectrum Disorder2 trials

Alzheimer's Disease2 trials

Psychiatric Disorder1 trial

Elderly Participants1 trial

References

Drug Info

Quick Facts

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