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AXS-05

5 trials in this asset. Source: ClinicalTrials.gov, as of July 21, 2026.

Trials

5

Ongoing

0

Recruiting

0

Completed

4

Sites

174

Countries

4

Endpoints

10

Composite endpoints

0

Distinct sites and countries across this asset's trials. A site running several of its trials counts once, matching the map. All 10 linked ClinicalTrials.gov endpoints are classified into the categories below. Trial and endpoint linkage does not by itself establish treatment attribution for every endpoint.

Development

Where the program stands

Trials by phase

Phase 2/3
1
Phase 3
4

Trials by status

Completed
4
Terminated
1

Evidence coverage

What this asset has been measured on

Endpoints grouped into outcome categories, ranked by how often they are measured across this asset's trials.

Behavior / neuropsychiatric
6
Safety / tolerability / PK
4

Most-measured metrics

Top 20 metrics across this asset's endpoints

Normalized metric codes are available for 0 of 10 classified ClinicalTrials.gov endpoints for this asset; the ranking below covers that coded subset.

No normalized metric codes are available for this asset.

Trials

Trials for this asset

Every trial for this asset, with the same search, filters, and sort as the Trials tab.

5 of 5

Alzheimer’s disease and related dementias trials
Asset / Disease areaKey I/E criterionEvidence
ADVANCEAddressing Dementia Via Agitation-Centered Evaluation

AXS-05, Bupropion

Alzheimer’s disease

Alzheimer's diseasePh 2/3Completed78Apr 2020-results
ACCORDAssessing Clinical Outcomes in Alzheimer's Disease Agitation

AXS-05

Alzheimer’s disease

Alzheimer's diseasePh 3Completed63Nov 2022-
ADVANCE-2A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation

AXS-05

Alzheimer’s disease

Alzheimer's diseasePh 3Completed55Nov 2024-
ACCORD-2A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation

AXS-05

Alzheimer’s disease

Study partner/caregiver requiredPh 3Completed47Dec 2024-
NCT06736509An 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

AXS-05

Alzheimer’s disease

Study partner/caregiver requiredPh 3Terminated22Feb 2025-results

Showing 1-5 of 5 trials