Dextromethorphan/Bupropion · Auvelity, AXS-05

What is Dextromethorphan/Bupropion?

Dextromethorphan/Bupropion (AUVELITY) is a fixed-dose combination tablet containing dextromethorphan, an NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion, a norepinephrine and dopamine reuptake inhibitor. Bupropion inhibits CYP450 2D6, increasing dextromethorphan bioavailability.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as

Auvelity, AXS-05, Dextromethorphan-Bupropion

Drug type

Small molecule

Targets

NMDA receptor (GRIN1), sigma-1 receptor (SIGMAR1), norepinephrine transporter (SLC6A2) (secondary target), dopamine transporter (SLC6A3) (secondary target)

Mechanism

Antagonist of NMDA receptor (GRIN1) and sigma-1 receptor (SIGMAR1)

Pathways

monoamine reuptake inhibition

Therapy area

Psychiatry

Developer

Axsome Therapeutics, Inc. (AXSM)

FDA status

Approved as Auvelity, NDA215430 · FDA label

✅ FDA-approved uses

• Major Depressive Disorder
• Agitation Associated with Dementia Due to Alzheimer's Disease

From the indications section of the FDA label (version of Aug 17, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Major Depressive Disorder (MDD)Smoking CessationDepressionMajor Depressive DisorderTreatment Resistant Depression

Other drugs acting on GRIN1 / SIGMAR1

More from Axsome Therapeutics

Sources

• FDA label (DailyMed)
• FDA label Auvelity (2026-08-17), indications
• NCI Thesaurus
• ClinicalTrials.gov NCT04039022
• ClinicalTrials.gov NCT06223880
• ClinicalTrials.gov NCT07523048
• ClinicalTrials.gov NCT07766655

Updated Oct 3, 2026. Something wrong or missing? Report it on the AXSM page.