AXS-05 (dextromethorphan-bupropion)

DRUG4 trials

Sponsors

Axsome Therapeutics, Inc.

Conditions

Agitation in Patients With Dementia of the Alzheimer's TypeAgitation, PsychomotorAlzheimer DiseaseMajor Depressive DisorderSmoking CessationTreatment Resistant Depression

Phase 2

Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)

TerminatedNCT04634669

Axsome Therapeutics, Inc.Major Depressive Disorder, Treatment Resistant Depression

Start: 2020-09-23End: 2022-03-04Updated: 2026-01-28

Phase 3

A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation

CompletedNCT04947553

Axsome Therapeutics, Inc.Agitation in Patients With Dementia of the Alzheimer's Type, Agitation, Psychomotor, Alzheimer Disease

Start: 2021-06-17End: 2024-12-21Updated: 2025-12-08

An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study

TerminatedNCT06736509

Axsome Therapeutics, Inc.Agitation in Patients With Dementia of the Alzheimer's Type, Agitation, Psychomotor, Alzheimer Disease

Start: 2024-11-21End: 2025-04-25Updated: 2026-06-25

Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)

RecruitingNCT07766655

Axsome Therapeutics, Inc.Smoking Cessation

Start: 2026-08-27End: 2027-12-01Target: 705Updated: 2026-09-08