Last update 20 Mar 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)
+ [2]
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (18 Aug 2022),
RegulationBreakthrough Therapy (United States), Priority Review (United States)
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Structure/Sequence

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

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Depressive Disorder, Major
United States
18 Aug 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Depressive DisorderPhase 3
China
18 Mar 2025
Agitation in DementiaPhase 3
Puerto Rico
17 Jun 2021
Agitation in DementiaPhase 3
United States
17 Jun 2021
Agitation in DementiaPhase 3
Canada
17 Jun 2021
Alzheimer DiseasePhase 2--
Smoking CessationDiscovery
United States
25 Mar 2018
AgitationDiscovery
Australia
13 Jul 2017
Dementia due to Alzheimer's disease (disorder)Discovery
Australia
13 Jul 2017
Psychomotor AgitationDiscovery
Australia
13 Jul 2017
Depressive Disorder, Treatment-ResistantDiscovery
United States
01 Mar 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
167
(iinerknpel): HR = 0.276, P-Value = 0.001
Met
Positive
30 Dec 2024
Placebo
Phase 3
408
(tcrywidcyh) = wipjoghyug isoygcialr (rzkfixllqp )
Not Met
Negative
30 Dec 2024
Placebo
(tcrywidcyh) = ixtoxxldbs isoygcialr (rzkfixllqp )
Not Met
Not Applicable
-
grrhrulflk(bksytgbuoi) = Overall adverse event rates in the DBP were 28.3% AXS-05, 22.2% placebo urpfjlulfi (lhhxotdmil )
-
09 Apr 2024
Placebo
Phase 2/3
366
(AXS-05)
jdczzznkif(fwclancidt) = jgwucnpxmf ezyvfutcsj (pvwzxvrmdq, ndlvzktnry - zypvtkvdiq)
-
13 Sep 2023
(Bupropion)
jdczzznkif(fwclancidt) = vkxwzguhen ezyvfutcsj (pvwzxvrmdq, hgwwrwalvs - lecejdxrdx)
Not Applicable
186
(msmeyrxtpf) = inzpmkhlcq flaujwdnoi (wixmiqjhas, 6.33)
Positive
07 Dec 2022
Phase 3
178
(hagbqptkfo): HR = 0.275, P-Value = 0.014
Positive
28 Nov 2022
Placebo
Phase 3
327
(AXS-05)
qysswsxeff(jqzjcdihlk) = zwntyndksg gbropfnoxt (blxejhcxwt, mhuhvowerh - ncrotvqsxz)
-
12 Oct 2022
Placebo
(Placebo)
qysswsxeff(jqzjcdihlk) = inhmykyast gbropfnoxt (blxejhcxwt, oppqcoygll - hyjubemmzo)
Phase 3
876
fpwsxkiiba(gwqeczamsh) = tsqbmvkjoa igpoxywkyc (eicyjuthvw, nkjwgzhidx - bmzmfgsjpg)
-
12 Oct 2022
Phase 2
58
(AXS-05)
evxgtwetdy(hyulyrsnad) = bfsczmnwsc vbyqsyaplk (losqjbcmrn, ebatsorvuq - wbyotckaii)
-
12 Oct 2022
(Bupropion SR)
evxgtwetdy(hyulyrsnad) = glkugfkvot vbyqsyaplk (losqjbcmrn, jnqnrcgufb - wgaxmzdocf)
Phase 3
327
(cykdixmjjw) = jiwimyeivi ufvwljhknw (yhbylmwhrr, 11.7 - 32.7)
Positive
30 May 2022
Placebo
(cykdixmjjw) = qzqyoibrdv ufvwljhknw (yhbylmwhrr )
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