Drug research

AXS-05 (dextromethorphan-bupropion)

Open a linked trial to see its study details and recorded changes, or check the regulatory events below and follow their sources.

Drug identity checked against registry records

Also recorded as AXS-05; dextromethorphan-bupropion

A drug appearing in a clinical trial does not mean it is FDA-approved. Check the original regulatory source for any approval claim.

Included trials

Trial	Sponsor	Phase	Status	Primary completion
Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)NCT04634669	AXSM	Phase 2	Terminated	2022-02-18Actual
A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease AgitationNCT04947553	AXSM	Phase 3	Completed	2024-12-03Actual
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 StudyNCT06736509	AXSM	Phase 3	Terminated	2025-02-17Actual

AXSMTerminatedPrimary completion: 2022-02-18 · Actual

Trial details

AXSMCompletedPrimary completion: 2024-12-03 · Actual

Trial details

AXSMTerminatedPrimary completion: 2025-02-17 · Actual

Trial details

No regulatory events match this view.Try another date range or view. Events appear after automated source checks. This does not mean no FDA events have occurred. Dates that a source does not disclose stay undisclosed.