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AXS-05

Alternative Names: axs-05, axs05, axs 05
Latest Update: 2024-10-15
Latest Update Note: News Article

Product Description

AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for the treatment of central nervous system (CNS) conditions. AXS-05 consists of a proprietary formulation and dose of dextromethorphan (DM) and bupropion. (Sourced from: https://www.axsome.com/axs-pipeline/about-axs-05)

Mechanisms of Action: NDR Inhibitor,S1R Inhibitor,NMA Inhibitor

Novel Mechanism: Yes

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: Breakthrough Therapy - Alzheimer Disease *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Axsome
Company Location: NEW YORK NY 10007
Company CEO: Herriot Tabuteau
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for AXS-05

Countries in Clinic: Canada, United States

Active Clinical Trial Count: 5

Highest Development Phases

Phase 3: Alzheimer Disease|Psychomotor Agitation

Phase 2: Depressive Disorder, Major|Depressive Disorder, Treatment-Resistant|Smoking Cessation|Tobacco Use Disorder

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

ADVANCE-2

P3

Recruiting

Psychomotor Agitation|Alzheimer Disease

2025-06-01

31%

AXS-05-AD-303

P3

Enrolling by invitation

Psychomotor Agitation|Alzheimer Disease

2024-12-01

31%

ACCORD

P3

Completed

Psychomotor Agitation|Alzheimer Disease

2022-11-21

31%

EVOLVE

P2

Completed

Depressive Disorder, Major|Depressive Disorder, Treatment-Resistant

2022-03-04

32%

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