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bupropion

Trade name: wellbutrin

Small moleculeapproved

Approved

Dec 30, 1985

Bupropion, an antidepressant of the aminoketone class and a non-nicotine aid to smoking cessation, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Compared to classical tricyclic antidepressants, Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine, serotonin, and dopamine. In addition, Bupropion does not inhibit monoamine oxidase. Bupropion produces dose-related central nervous system (CNS) stimulant effects in animals, as evidenced by increased locomotor activity, increased rates of responding in various schedule-controlled operant behavior tasks, and, at high doses, induction of mild stereotyped behavior. Bupropion is marketed as Wellbutrin, Zyban, and generics. Bupropion is indicated for the treatment of major depressive disorder (MDD). WELLBUTRIN, WELLBUTRIN SR, and WELLBUTRIN XL are not approved for smoking cessation treatment, but bupropion under the name ZYBAN is approved for this use. — NCATS

Clinical trial activity

385 trials · 269 clinical orgs · 50 marketing orgs

Phase 1
79
Phase 2
131
Phase 3
84
Phase 4
114

Earliest trial started Sep 1, 1994 (NCT00000276)

Timeline

1980s

  1. Dec 30, 1985

    GlaxoSmithKline — Earliest FDA Approval

  2. Dec 30, 1985

    GlaxoSmithKline — NDA Organization

  3. Dec 30, 1985

    GlaxoSmithKline — NDA Secondary Org

1990s

  1. Jan 1, 1994

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

  3. Nov 29, 1999

    Teva — Marketing Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

  2. Feb 7, 2000

    Sandoz — Marketing Organization

  3. Feb 7, 2000

    Apnar Pharma — Marketing Organization

  4. Apr 17, 2000

    Mylan — Marketing Organization

  5. Apr 17, 2000

    Aurobindo Pharma — Marketing Organization

  6. Oct 10, 2000

    Invatech — Marketing Organization

  7. Aug 28, 2003

    Bausch Health Companies — Marketing Organization

  8. Nov 25, 2003

    Epic Pharma Llc — Marketing Organization

  9. Jan 28, 2004

    Impax Laboratories — Marketing Organization

  10. Jul 14, 2005

    Novartis — Marketing Organization

  11. Jul 14, 2005

    Chartwell Pharmaceuticals — Marketing Organization

  12. Jan 17, 2006

    Apotex — Marketing Organization

  13. Dec 14, 2006

    Anchen Pharmaceuticals, Inc — Marketing Organization

  14. Dec 14, 2006

    Endo Pharmaceuticals — Marketing Organization

  15. Dec 14, 2006

    PH HEALTH — Marketing Organization

  16. Jun 13, 2007

    Actavis — Marketing Organization

  17. Apr 23, 2008

    Bausch Health Companies — NDA Secondary Org

2010s

  1. Apr 6, 2010

    Sun Pharmaceuticals — Marketing Organization

  2. May 3, 2010

    Rising Pharmaceuticals — Marketing Organization

  3. Nov 10, 2011

    Alvogen — Marketing Organization

  4. Nov 10, 2011

    Alvogen — NDA Secondary Org

  5. Aug 30, 2012

    Wockhardt — Marketing Organization

  6. Aug 13, 2013

    Watson Pharmaceuticals — Marketing Organization

  7. Oct 11, 2013

    Jubilant Innovation Ltd. — Marketing Organization

  8. Jan 17, 2014

    Zydus Discovery DMCC — Marketing Organization

  9. Sep 10, 2014

    Nalpropion — Marketing Organization

  10. Sep 10, 2014

    Nalpropion — NDA Secondary Org

  11. Oct 31, 2014

    Torrent Pharmaceuticals Limited — Marketing Organization

  12. May 26, 2015

    Prinston Inc — Marketing Organization

  13. Feb 9, 2016

    Invagen Pharms — Marketing Organization

  14. Feb 9, 2016

    Cipla — Marketing Organization

  15. Mar 1, 2016

    Sciegen Pharmaceticals — Marketing Organization

  16. Aug 19, 2016

    Heritage Pharma — Marketing Organization

  17. Aug 19, 2016

    Emcure — Marketing Organization

  18. Apr 6, 2017

    Lupin — Marketing Organization

  19. Jun 30, 2017

    Anbison Lab — Marketing Organization

  20. Aug 21, 2017

    Sinotherapeutics — Marketing Organization

  21. Nov 3, 2017

    TWi Biotechnology, Inc. — Marketing Organization

  22. Nov 3, 2017

    ScinoPharm Taiwan — Marketing Organization

  23. Jun 8, 2018

    Alembic — Marketing Organization

  24. Jun 14, 2018

    Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization

  25. Oct 31, 2018

    Accord Research — Marketing Organization

  26. Jan 28, 2019

    Adaptis Pharma — Marketing Organization

  27. Jan 28, 2019

    Graviti Pharmaceuticals — Marketing Organization

  28. Sep 5, 2019

    Zhejiang Jutai Pharm — Marketing Organization

2020s

  1. Jan 16, 2020

    Cadila Healthcare — Marketing Organization

  2. Apr 20, 2020

    Micro Labs Ltd India — Marketing Organization

  3. Feb 2, 2022

    Granules India — Marketing Organization

  4. Aug 18, 2022

    Axsome Therapeutics, Inc. — NDA Secondary Org

  5. Nov 29, 2022

    AbbVie — Marketing Organization

  6. May 31, 2023

    Annora Pharma — Marketing Organization

  7. May 2, 2025

    IPCA Laboratories Ltd. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewDec 30, 1985

Chemistry & pharmacology

Loading structure…

SMILES

Cl.CC(NC(C)(C)C)C(=O)C1=CC=CC(Cl)=C1
Mol. weight
276.202 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 323u66
  • 323u66
  • amfebutamon
  • amfebutamone
  • amfebutamone
  • amfebutamone
  • amfebutamone hcl
  • amfebutamone hcl
  • aplenzin
  • aplenzin
  • aplenzin
  • bupropion
  • bupropion
  • bupropion
  • bupropion
  • bupropion
  • bupropion
  • bupropion
  • bupropion
  • bupropion
  • bupropion
  • bupropion
  • (+/-)-bupropion
  • bupropion hcl
  • bupropion hcl
  • bupropion hcl
  • bupropion hydrobromide
  • bupropion hydrobromide
  • bupropion hydrobromide
  • bupropion hydrobromide
  • bupropion hydrobromide
  • bupropion hydrochloride
  • bupropion hydrochloride
  • bupropion hydrochloride
  • bupropion hydrochloride
  • bupropion hydrochloride
  • bupropion hydrochloride / naltrexone hydrochloride
  • bw-323
  • bw-323
  • elontril
  • forfivo xl
  • forfivo xl
  • gsk seasonal affective disorder drug
  • lorexys
  • tba-7371
  • wellbutrin
  • wellbutrin
  • wellbutrin
  • wellbutrin
  • wellbutrin
  • wellbutrin 100
  • wellbutrin 75
  • wellbutrin sr
  • wellbutrin sr
  • wellbutrin xl
  • wellbutrin xl
  • zyban
  • zyban
  • zyban

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07269873Phase 1Jan 13, 2026BioCorRx Pharmaceuticals, Inc., National Institute on Drug Abuse (NIDA)
NCT07224087Phase 1Jan 1, 2026Yale University
NCT07266545Phase 4Dec 31, 2025Mayo Clinic
NCT07213466Phase 4Dec 1, 2025Mayo Clinic, University of Toronto
NCT07223671Phase 1Nov 12, 2025Bristol-Myers Squibb
NCT07171112Phase 2Nov 6, 2025Mayo Clinic
NCT07235748Phase 1Oct 7, 2025Servier
NCT06973005Phase 1May 8, 2025AstraZeneca, Parexel
NCT06957223N/AMay 6, 2025CMH Nowshera, Pakistan Army
NCT06845345Phase 4Apr 14, 2025Franciscus Gasthuis
NCT06958692Phase 3Apr 11, 2025Yiling Pharmaceutical Inc.
NCT06854614Phase 4Mar 1, 2025The Cleveland Clinic
NCT06679413Phase 1Dec 6, 2024UCB
NCT06609343Phase 1/Phase 2 (Phase 2)Nov 30, 2024University of Texas, San Antonio
NCT06736509Phase 3Nov 21, 2024Axsome Therapeutics, Inc.
NCT06620562Phase 4Oct 15, 2024Laval University
NCT06516055Phase 2Oct 1, 2024S1 Biopharma, Inc.
NCT06605703Phase 4Sep 18, 2024Weight Watchers International
NCT06564441Phase 1Sep 5, 2024Boehringer Ingelheim
NCT06566794N/AAug 20, 2024University of Helsinki
Showing 20 of 385 trials
Page 1 / 20

Organizations

Research & Development (269)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute on Drug Abuse (NIDA)Government552051994
GlaxoSmithKlineFor profit301741999
Columbia UniversityAcademic/Hospital191551995
Yale UniversityAcademic/Hospital191751994
National Institute of Mental Health (NIMH)Government18441995
Orexigen Therapeutics, IncFor profit171642005
Department of Veteran AffairsGovernment16951994
Duke UniversityAcademic/Hospital161542006
Axsome Therapeutics, Inc.For profit141332016
National Cancer Institute (NCI)Government14142001
Harvard UniversityAcademic/Hospital12841998
University of TorontoAcademic/Hospital11752004
University of California, Los AngelesAcademic/Hospital10632002
University of Texas at HoustonAcademic/Hospital10842001
Mayo ClinicAcademic/Hospital9831998
National Institutes of Health (NIH)Government9241999
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Government8331998
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government7022015
The University of Texas, DallasAcademic/Hospital7522001
Canadian Institutes of Health Research (CIHR)Academic/Hospital6052005
269 organizations
Page 1 / 14

Marketing (60)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGNov 29, 2022
Accord ResearchFor profitMKTGOct 31, 2018
ActavisFor profitMKTGJun 13, 2007
Adaptis PharmaFor profitMKTGJan 28, 2019
AlembicFor profitMKTGJun 8, 2018
AlembicFor profitSYNJun 8, 2018
AlvogenFor profitMKTGNov 10, 2011
AlvogenFor profitNDA2Nov 10, 2011
Anbison LabFor profitMKTGJun 30, 2017
Anchen Pharmaceuticals, IncFor profitMKTGDec 14, 2006
Annora PharmaFor profitMKTGMay 31, 2023
Apnar PharmaFor profitMKTGFeb 7, 2000
ApotexFor profitMKTGJan 17, 2006
ApotexFor profitSYNJan 17, 2006
Aurobindo PharmaFor profitMKTGApr 17, 2000
Axsome Therapeutics, Inc.For profitNDA2Aug 18, 2022
Bausch Health CompaniesFor profitSYNAug 28, 2003
Bausch Health CompaniesFor profitMKTGAug 28, 2003
Bausch Health CompaniesFor profitNDA2Apr 23, 2008
Cadila HealthcareFor profitMKTGJan 16, 2020
Chartwell PharmaceuticalsFor profitMKTGJul 14, 2005
CiplaFor profitMKTGFeb 9, 2016
EmcureFor profitMKTGAug 19, 2016
Endo PharmaceuticalsFor profitMKTGDec 14, 2006
Epic Pharma LlcFor profitMKTGNov 25, 2003
Epic Pharma LlcFor profitSYNNov 25, 2003
GlaxoSmithKlineFor profitNDADec 30, 1985
GlaxoSmithKlineFor profitNDA2Dec 30, 1985
Granules IndiaFor profitMKTGFeb 2, 2022
Graviti PharmaceuticalsFor profitMKTGJan 28, 2019
Heritage PharmaFor profitMKTGAug 19, 2016
IPCA Laboratories Ltd.For profitMKTGMay 2, 2025
Impax LaboratoriesFor profitMKTGJan 28, 2004
Invagen PharmsFor profitMKTGFeb 9, 2016
InvatechFor profitMKTGOct 10, 2000
Jubilant Innovation Ltd.For profitMKTGOct 11, 2013
LupinFor profitMKTGApr 6, 2017
Micro Labs Ltd IndiaFor profitMKTGApr 20, 2020
MylanFor profitMKTGApr 17, 2000
NalpropionFor profitMKTGSep 10, 2014
NalpropionFor profitNDA2Sep 10, 2014
NovartisFor profitMKTGJul 14, 2005
PH HEALTHFor profitMKTGDec 14, 2006
Prinston IncFor profitMKTGMay 26, 2015
Rising PharmaceuticalsFor profitMKTGMay 3, 2010
SandozFor profitMKTGFeb 7, 2000
SandozFor profitSYNMar 12, 2008
Sciegen PharmaceticalsFor profitMKTGMar 1, 2016
ScinoPharm TaiwanFor profitMKTGNov 3, 2017
SinotherapeuticsFor profitMKTGAug 21, 2017
Sun PharmaceuticalsFor profitSYNApr 6, 2010
Sun PharmaceuticalsFor profitMKTGApr 6, 2010
TWi Biotechnology, Inc.For profitMKTGNov 3, 2017
TevaFor profitMKTGNov 29, 1999
Torrent Pharmaceuticals LimitedFor profitMKTGOct 31, 2014
Watson PharmaceuticalsFor profitMKTGAug 13, 2013
WockhardtFor profitMKTGAug 30, 2012
Yichang Humanwell Pharmaceutical Co.,LtdFor profitMKTGJun 14, 2018
Zhejiang Jutai PharmFor profitMKTGSep 5, 2019
Zydus Discovery DMCCFor profitMKTGJan 17, 2014