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

A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, Explore the Effect of Food After Multiple Doses of Selected Prototypes, and Evaluate Alternative Formulations of KarX and KarXT Following Single and Multiple Ascending Doses (clinicaltrials.gov) - P1 | N=236 | Recruiting | Sponsor: Bristol-Myers Squibb | N=72 ➔ 236

Enrollment change

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 | Trial completion date: Aug 2026 ➔ Mar 2027 | Trial primary completion date: Aug 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date

CN0120021: Phase 3 Evaluation of KarXT and KarXT+KarX-EC in Schizophrenia and Autism-Related Irritability in Youth, respectively. (clinicaltrialsregister.eu) - P2/3 | N=40 | Not yet recruiting | Sponsor: Bristol-Myers Squibb Services Unlimited Company

New P2/3 trial • 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 | N=103 ➔ 352

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

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 • p-tau181

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 | N=193 ➔ 600

Enrollment change • Alzheimer's Disease • CNS Disorders

A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5) (clinicaltrials.gov) - P3 | N=325 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting | N=1046 ➔ 325 | Trial completion date: Oct 2027 ➔ Mar 2028 | Initiation date: Jul 2025 ➔ Mar 2026 | Trial primary completion date: Sep 2027 ➔ Mar 2028

Enrollment change • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Psychiatry

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 | Initiation date: Feb 2026 ➔ Sep 2026

Trial initiation date • Autism Spectrum Disorder • Genetic Disorders

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 | Initiation date: Feb 2026 ➔ Sep 2026

Trial initiation date • Autism Spectrum Disorder • Genetic Disorders

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