AXS-05

Phase 3Small molecule

AAxsome Therapeutics, Inc.

AXS-05 is one of 6 small molecule programs targeting Depressive Symptoms. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Depressive SymptomsRecruiting

Depressive SymptomsPhase 3

Recruiting

Competition

Competitive Landscape

5 competitors in Depressive Symptoms

#DrugCompanyPhaseTrials

Olumiant

Eli Lilly

Phase 2

1 2

AXS-05

AAxsome Therapeutics, Inc.

Phase 3

1 3

Psilocybin

COMPASS Pathways

Phase 1

1 4

Ci-581a

NNew York State Psychiatric Institute

Phase 2

1 5

Ci-581b

NNew York State Psychiatric Institute

Phase 2

1 6

Hypoxia

UUniversity of Aarhus

Preclinical

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

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Smoking Cessation

NCT07766655

Clinical

Trials by Indication[1]

Agitation5 trials

Assessing Clinical Outcomes in Alzheimer's Disease Agitation

Completed·AAxsome Therapeutics, Inc.·Phase 3·NCT04797715·178 enrolled

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

Completed·AAxsome Therapeutics, Inc.·Phase 3·NCT04947553·456 enrolled

Addressing Dementia Via Agitation-Centered Evaluation

Completed·AAxsome Therapeutics, Inc.·Phase 2/3·NCT03226522·366 enrolled

Show 2 more trials

ADVANCE-2: Addressing Dementia Via Agitation-Centered Evaluation 2: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Alzheimer's Disease Agitation

Completed·AAxsome Therapeutics, Inc.·Phase 3·NCT05557409·408 enrolled

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

Terminated·AAxsome Therapeutics, Inc.·Phase 3·NCT06736509·139 enrolled

Depression2 trials

Open-Label Safety Study of AXS-05 in Subjects With Depression

Completed·AAxsome Therapeutics, Inc.·Phase 3·NCT04039022·876 enrolled

Assessing Symptomatic Clinical Episodes in Depression

Completed·AAxsome Therapeutics, Inc.·Phase 2·NCT03595579·97 enrolled

Major Depressive Disorder2 trials

A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder

Completed·AAxsome Therapeutics, Inc.·Phase 3·NCT02741791·312 enrolled

A Trial of AXS-05 in Patients With Major Depressive Disorder

Completed·AAxsome Therapeutics, Inc.·Phase 3·NCT04019704·327 enrolled

Smoking Behavior1 trial

AXS-05 Phase II Trial on Smoking Behavior

Completed·JJames Davis·Phase 2·NCT03471767·58 enrolled

Treatment1 trial

An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients

Unknown status·AAxsome Therapeutics, Inc.·Phase 2·NCT04971291·312 enrolled

3 more indications

Depressive Symptoms1 trial

A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms

Recruiting·AAxsome Therapeutics, Inc.·Phase 4·NCT06223880·350 enrolled

Smoking Cessation1 trial

A Randomized, Double-Blind, Placebo and Active-Controlled Trial to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults

Recruiting·AAxsome Therapeutics, Inc.·Phase 3·NCT07766655·705 enrolled

Unspecified2 trials

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

Terminated·AAxsome Therapeutics, Inc.·Phase 2·NCT04634669·181 enrolled

Mechanistic Evaluation of Response in TRD (MERIT)

Completed·AAxsome Therapeutics, Inc.·Phase 2·NCT04608396·44 enrolled

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for AXS-05. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — AXS-05 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for AXS-05. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Axsome Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAxsome Therapeutics, Inc.

AXS-05

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Agitation5 trials

Depression2 trials

Major Depressive Disorder2 trials

Smoking Behavior1 trial

Treatment1 trial

Depressive Symptoms1 trial

Smoking Cessation1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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