KarXT

Phase 3Small molecule

Bristol-Myers Squibb

KarXT is one of 82 small molecule programs targeting Schizophrenia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

SchizophreniaRecruiting

ManiaRecruiting

Irritability Associated With Autism Spectrum DisorderNot yet recruiting

Alzheimer DiseaseRecruiting

Psychosis Associated With Alzheimer's DiseaseRecruiting

Bipolar Disorder Type I With Mania or Mania With Mixed FeaturesRecruiting

SchizophreniaPhase 3

Recruiting

ManiaPhase 3

Recruiting

Irritability Associated With Autism Spectrum DisorderPhase 3

Not yet recruiting

Alzheimer DiseasePhase 3

Recruiting

Psychosis Associated With Alzheimer's DiseasePhase 3

Recruiting

Bipolar Disorder Type I With Mania or Mania With Mixed FeaturesPhase 3

Recruiting

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

KarXT

Bristol-Myers Squibb

Phase 3

5 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Inapsine

Jazz Pharmaceuticals

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Catapres

Boehringer Ingelheim

Preclinical

1 9

Luvox

SSolvay Pharmaceuticals

Preclinical

1 10

Persantine

Boehringer Ingelheim

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Psychosis Associated With Alzheimer's Disease

NCT05511363

Phase 3Recruiting

Mania

NCT06951698

Phase 3Recruiting

Bipolar Disorder Type I With Mania or Mania With Mixed Features

NCT06951711

ApprovedRecruiting

Study completion

NCT07681076

Phase 3Recruiting

Psychosis Associated With Alzheimer's Disease

NCT06126224

Phase 3Recruiting

Alzheimer Disease

NCT06585787

Clinical

Trials by Indication[1]

Schizophrenia5 trials

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 Years of Age)

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT07288567·166 enrolled

An Open-label, Phase 1, Dose-Finding Study to Characterize the Safety, Tolerability, and Pharmacokinetics of a Long-Acting Injectable KarXT Formulation in Participants With Schizophrenia

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT07061288·131 enrolled

A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder

Recruiting·KKaruna Therapeutics·Phase 3·NCT07424404·400 enrolled

Show 2 more trials

A Phase 3, Randomized, Two-part Study With a 5-week Double-blind Part (Randomized, Parallelgroup, Placebo-controlled) Followed by a 52-week Open-label Extension Part to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Patients With Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) Schizophrenia

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06882785·250 enrolled

A Phase 3b, Open-label, Multicenter, Two-Period, Slow-titration and Food Effect Study to Assess the Safety and Efficacy of KarXT in Participants With DSM-5 Schizophrenia

Completed·KKaruna Therapeutics·Phase 3·NCT06572449·173 enrolled

Alzheimer disease3 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 for the Treatment of Psychosis Associated With Alzheimer's Disease

Recruiting·KKaruna Therapeutics·Phase 3·NCT06585787·406 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

Psychosis Associated With Alzheimer's Disease3 trials

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

Recruiting·KKaruna Therapeutics·Phase 3·NCT06126224·500 enrolled

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease

Recruiting·KKaruna Therapeutics·Phase 3·NCT05511363·410 enrolled

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

Recruiting·KKaruna Therapeutics·Phase 3·NCT05980949·1,000 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

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

6 more indications

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

Bipolar Disorder1 trial

A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06929273·450 enrolled

Bipolar Disorder Type I With Mania or Mania With Mixed Features1 trial

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06951711·274 enrolled

Mania1 trial

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06951698·274 enrolled

Unspecified2 trials

A Phase 4, Randomized, Open Label Study to Evaluate the Safety and Tolerability of Twice Daily Xanomeline/Trospium Chloride (KarXT) With Prophylactic and PRN Antiemetic Use in Healthy Volunteers

Recruiting·KKaruna Therapeutics, Inc., a Bristol Myers Squibb company·Approved·NCT07681076·225 enrolled

A Phase 1, 3-part, Open-label Study to Evaluate the Effects of KarXT Administration on the Pharmacokinetics of Midazolam, Fexofenadine, and Digoxin in Healthy Adult Participants

Completed·KKaruna Therapeutics·Phase 1·NCT07118215·62 enrolled

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for KarXT. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — KarXT compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for KarXT. 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

KarXT

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Schizophrenia5 trials

Alzheimer disease3 trials

Psychosis Associated With Alzheimer's Disease3 trials

Alzheimer's Disease2 trials

Irritability Associated With Autism Spectrum Disorder2 trials

Psychiatric Disorder1 trial

Elderly Participants1 trial

Bipolar Disorder1 trial

Bipolar Disorder Type I With Mania or Mania With Mixed Features1 trial

Mania1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

Related News