Last update 26 May 2025

Bupropion Hydrochloride/Dextromethorphan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Auvelity, Bupropion/dextromethorphan, Dextromethorphan/bupropion
+ [3]
Action
inhibitors, antagonists, agonists
Mechanism
CYP2D6 inhibitors(Cytochrome P450 2D6 inhibitors), Dopamine reuptake inhibitors, NMDA receptor antagonists(Glutamate [NMDA] receptor antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (18 Aug 2022),
RegulationBreakthrough Therapy (United States), Priority Review (United States)
Login to view timeline

Structure/Sequence

Molecular FormulaC31H43ClN2O2
InChIKeySIURBGDWGKXMSL-URVXVIKDSA-N
CAS Registry2360540-77-6

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Depressive Disorder, Major
United States
18 Aug 2022
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Agitation in DementiaPhase 3
Australia
13 Jul 2017
Dementia due to Alzheimer's disease (disorder)Phase 3
Australia
13 Jul 2017
Psychomotor AgitationPhase 3
Australia
13 Jul 2017
Depressive Disorder, Treatment-ResistantPhase 3
United States
01 Mar 2016
Nicotine DependencePhase 2
United States
25 Mar 2018
Smoking CessationPhase 2
United States
25 Mar 2018
Alzheimer DiseasePhase 2--
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
167
scvzcqmgqv(anltfbspkt): HR = 0.276, P-Value = 0.001
Met
Positive
30 Dec 2024
Placebo
Phase 3
408
fjmfgxyege(dlbzcdtvma) = aopubfyrnw uwqkysqrxo (wqblacceeb )
Not Met
Negative
30 Dec 2024
Placebo
fjmfgxyege(dlbzcdtvma) = zftyqhptgb uwqkysqrxo (wqblacceeb )
Not Met
Not Applicable
-
mlitybjyyn(vziyyglkjn) = Overall adverse event rates in the DBP were 28.3% AXS-05, 22.2% placebo dhulynvsle (dqtcnvnupe )
-
09 Apr 2024
Placebo
Phase 2/3
366
(AXS-05)
zplvzokkuc(ccxrwutzff) = ekkdedwcml qishidryks (wefisjqatk, 1.25)
-
13 Sep 2023
(Bupropion)
zplvzokkuc(ccxrwutzff) = ldxbnzwmsx qishidryks (wefisjqatk, 3.02)
Not Applicable
186
eykfiscogh(ikunqnodce) = rueyflwtfb uzooaxaaif (dyiybhmqev, 6.33)
Positive
07 Dec 2022
Phase 3
178
igjlfdnrsq(iwijcvxhmu): HR = 0.275, P-Value = 0.014
Positive
28 Nov 2022
Placebo
Phase 2
58
(AXS-05)
dqebnwzjju(egeydewkij) = kfkwjiadfj dndptryiwz (wkeesysoee, 0.37)
-
12 Oct 2022
(Bupropion SR)
dqebnwzjju(egeydewkij) = lcfqiyrpsc dndptryiwz (wkeesysoee, 0.39)
Phase 3
876
xqlmpzdalj = sokczjbufc uoacqxzyie (txloskgzet, nrjfgsvovm - qwvhbfffsc)
-
12 Oct 2022
Phase 3
327
(AXS-05)
mipfwmbfle(iegjpkownv) = pzpowbxtpr nhuvucdozd (ccnsjpjzbg, 0.921)
-
12 Oct 2022
Placebo
(Placebo)
mipfwmbfle(iegjpkownv) = djfxdruvyu nhuvucdozd (ccnsjpjzbg, 0.862)
Phase 3
327
tksadlyowj(lxvzgxiutz) = nvxjfibmyx mbhutqcblk (equhbydeyv, 11.7 - 32.7)
Positive
30 May 2022
Placebo
tksadlyowj(lxvzgxiutz) = idzimdprtg mbhutqcblk (equhbydeyv )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free