xanomeline enteric capsule (KarX-EC) / BMS - LARVOL DELTA

A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company | Not yet recruiting ➔ Recruiting

Enrollment open • Autism Spectrum Disorder • CNS Disorders • Genetic Disorders • Psychiatry • Schizophrenia

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1) (clinicaltrials.gov) - P3 | N=352 | Recruiting | Sponsor: Bristol-Myers Squibb

Trial initiation date • Alzheimer's Disease • CNS Disorders • Aβ42 • CSF Aβ42 • p-tau181

CN012-0024: A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for thenTreatment of Agitation Associated with Alzheimers Disease. (clinicaltrialsregister.eu) - P2/3 | N=90 | Recruiting | Sponsor: Bristol-Myers Squibb Services Unlimited Company

New P2/3 trial • Alzheimer's Disease • CNS Disorders • Aβ42 • CSF Aβ42 • p-tau181

A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: Karuna Therapeutics

New P3 trial • Autism Spectrum Disorder • CNS Disorders • Genetic Disorders • Psychiatry • Schizophrenia

A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism (clinicaltrials.gov) - P3 | N=176 | Not yet recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Jul 2026 ➔ Jul 2029 | Trial primary completion date: Jul 2026 ➔ Jul 2029

Trial completion date • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Bristol-Myers Squibb | N=48 ➔ 72 | Trial completion date: Feb 2026 ➔ Aug 2026 | Trial primary completion date: Feb 2026 ➔ Aug 2026

Enrollment change • Trial completion date • Trial primary completion date

A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism (clinicaltrials.gov) - P3 | N=176 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P3 trial • Autism Spectrum Disorder • Genetic Disorders

A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder (clinicaltrials.gov) - P3 | N=176 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P3 trial • Autism Spectrum Disorder • Genetic Disorders

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT and KarXT + KarX-EC in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) (clinicaltrials.gov) - P3 | N=800 | Recruiting | Sponsor: Karuna Therapeutics | N=600 ➔ 800

Enrollment change • Alzheimer's Disease • CNS Disorders • Psychiatry

A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed | N=36 ➔ 24 | Trial completion date: Jan 2026 ➔ Jul 2025 | Trial primary completion date: Jan 2026 ➔ Jul 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Mental Retardation • Psychiatry

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1) (clinicaltrials.gov) - P3 | N=352 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

MINDSET 1: A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (clinicaltrials.gov) - P3 | N=586 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2) (clinicaltrials.gov) - P3 | N=352 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2) (clinicaltrials.gov) - P3 | N=586 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

CN012-0030: 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 (clinicaltrials.gov) - P1 | N=78 | Completed | Sponsor: Karuna Therapeutics | Recruiting ➔ Completed

Trial completion

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1) (clinicaltrials.gov) - P3 | N=352 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P3 trial • Alzheimer's Disease • CNS Disorders

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2) (clinicaltrials.gov) - P3 | N=352 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P3 trial • Alzheimer's Disease • CNS Disorders

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Nov 2028 ➔ Jul 2029 | Trial primary completion date: Nov 2028 ➔ Jun 2029

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2) (clinicaltrials.gov) - P3 | N=586 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P3 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

MINDSET 1: A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (clinicaltrials.gov) - P3 | N=586 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P3 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Mental Retardation • Psychiatry