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dobutamine

Trade name: dobutrex

Small moleculeapproved

Approved

Jul 18, 1978

Dobutamine is a sympathomimetic drug used in the treatment of heart failure and cardiogenic shock. Dobutamine hydrochloride is a direct-acting inotropic agent whose primary activity results from stimulation of the ß-receptors of the heart while producing comparatively mild chronotropic, hypertensive, arrhythmogenic, and vasodilative effects. It does not cause the release of endogenous norepinephrine, as does dopamine. Dobutamine directly stimulates beta-1 receptors of the heart to increase myocardial contractility and stroke volume, resulting in increased cardiac output. Dobutamine Injection, USP is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. — NCATS

Clinical trial activity

67 trials · 124 clinical orgs · 14 marketing orgs

Phase 1
10
Phase 2
23
Phase 3
9
Phase 4
18

Earliest trial started Oct 1, 1999 (NCT00100412)

Timeline

1970s

  1. Jul 18, 1978

    Eli Lilly — Earliest FDA Approval

  2. Jul 18, 1978

    Eli Lilly — NDA Organization

1990s

  1. Sep 27, 1993

    Hospira — NDA Secondary Org

  2. Sep 27, 1993

    Baxalta — NDA Secondary Org

  3. Sep 27, 1993

    Baxter — NDA Secondary Org

  4. Oct 19, 1993

    Teva — Marketing Organization

  5. Nov 29, 1993

    Hospira — Marketing Organization

  6. Nov 30, 1993

    Watson Pharmaceuticals — Marketing Organization

  7. Oct 31, 1994

    West-Ward Pharmaceutical — Marketing Organization

  8. Oct 31, 1994

    Hikma — Marketing Organization

  9. Feb 21, 1995

    Teligent Pharmaceuticals — Marketing Organization

  10. Sep 26, 1996

    Baxter — Marketing Organization

  11. Mar 31, 1998

    Dr. Reddy's Laboratories — Marketing Organization

  12. Jun 25, 1998

    Lutipold — Marketing Organization

  13. Jun 25, 1998

    Sankyo — Marketing Organization

  14. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Dec 21, 2022

    Hainan Poly Pharm — Marketing Organization

  2. Dec 21, 2022

    SLATE RUN PHARMA — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJul 18, 1978

Chemistry & pharmacology

Loading structure…

SMILES

CC(CCc1ccc(O)cc1)NCCc1ccc(O)c(O)c1
Mol. weight
301.39 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 3,4-dihydroxy-n-[3-(4-hydroxyphenyl)-1-methylpropyl]-beta-phenylethylamine
  • 3,4-dihydroxy-n-[3-(4-hydroxyphenyl)-1-methylpropyl]-beta-phenylethylamine
  • 4-{2-[3-(4-hydroxy-phenyl)-1-methyl-propylamino]-ethyl}-benzene-1,2-diol
  • 4-{2-[3-(4-hydroxy-phenyl)-1-methyl-propylamino]-ethyl}-benzene-1,2-diol
  • (+-)-4-(2-((3-(p-hydroxyphenyl)-1-methylpropyl)amino)ethyl)pyrocatechol
  • (+-)-4-(2-((3-(p-hydroxyphenyl)-1-methylpropyl)amino)ethyl)pyrocatechol
  • 46236
  • compound 81929
  • compound 81929
  • dl-dobutamine
  • dl-dobutamine
  • dobutamin
  • dobutamin
  • dobutamina
  • dobutamina
  • dobutamine
  • dobutamine
  • dobutamine
  • dobutamine
  • dobutamine
  • dobutamine
  • dobutamine
  • dobutamine
  • dobutamine
  • dobutamine
  • dobutamine hcl
  • dobutamine hcl
  • dobutamine hcl
  • dobutamine hydrochloride
  • dobutamine hydrochloride
  • dobutamine hydrochloride
  • dobutamine hydrochloride
  • dobutamine hydrochloride
  • dobutaminum
  • dobutaminum
  • dobutrex
  • dobutrex
  • dobutrex
  • doubtamine
  • posiject
  • posiject
  • rac-dobutamine
  • rac-dobutamine
  • racemic-dobutamine
  • racemic-dobutamine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07230106Phase 2Nov 30, 2025Hengrui Therapeutics, Inc.
NCT07000994N/AJun 16, 2025University of Hamburg
NCT06462313N/AJul 22, 2024Anhui Medical University, Chinese Academy of Medical Sciences, Fujian Medical University, Fujian Provincial Hospital, Guangdong Medical University, Guizhou Medical University, Henan Provincal People's Hospital, Huazhong University of Science and Technology, Lishui Country People's Hospital, Nanchang University, Ningbo No. 1 Hospital, Ningbo No. 2 Hospital, People's Liberation Army of China, Red Cross Hospital, Hangzhou, China, Shihezi University Medical College, Soochow University, Southern Medical University, The Central Hospital of Lishui City, The First People’s Hospital of Zunyi, Tianjin Medical University, University of South China, Weifang People's Hospital, Weihai Municipal Hospital, Wenzhou Medical University, Wuhan University, Xinjiang Medical University, Zhejiang University, Zhengzhou University, Zunyi Medical College
NCT06878742Phase 1/Phase 2 (Phase 2)Jun 24, 2024Universidad Autonoma de Madrid
NCT06478667Phase 3Jun 20, 2024Ain Shams University
NCT06318260Phase 1/Phase 2 (Phase 2)Apr 8, 2024Aarhus University
NCT06210217Early Phase 1 (Phase 1)Feb 1, 2024Sichuan University
NCT05999487N/AOct 31, 2023Cairo University
NCT05953142Phase 2Aug 1, 2023Federal University of Sao Paulo
NCT05700617Early Phase 1 (Phase 1)Jul 31, 2023University of Chicago
NCT05944146N/AMay 31, 2023Fudan University
NCT05594342Phase 3Jul 1, 2022The Young Investigator Group of Cardiovascular Research
NCT05196815N/AJul 1, 2022The Royal Wolverhampton NHS Trust
NCT05350592Phase 2Mar 7, 2022Novo Nordisk, University of Copenhagen
NCT05267886Phase 4Mar 5, 2022University of Ottawa
NCT05241912Early Phase 1 (Phase 1)Feb 28, 2022Guangzhou Red Cross Hospital
NCT05025644Phase 4Aug 31, 2021University of Toronto
NCT04893655Phase 4May 3, 2021Ghent University, Universitair Ziekenhuis Gent
NCT06784570Phase 2Jan 1, 2021Zagazig University
NCT04369573Phase 4May 4, 2020University of Milan
Showing 20 of 67 trials
Page 1 / 4

Organizations

Research & Development (124)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Heart, Lung, and Blood Institute (NHLBI)Government3022003
Universidad Autonoma de MadridAcademic/Hospital3212010
Aarhus UniversityAcademic/Hospital2222011
AbbottFor profit2112003
Department of Veteran AffairsGovernment2111999
Ghent UniversityAcademic/Hospital2212019
University of GrenobleAcademic/Hospital2222014
University of OttawaAcademic/Hospital2212017
University of Roma La SapienzaAcademic/Hospital2222007
Ain Shams UniversityAcademic/Hospital1112024
American Heart AssociationAcademic/Hospital1012013
Anhui Medical UniversityAcademic/Hospital1012024
AstellasFor profit1012009
AstraZenecaFor profit1012017
Autonomous University of MadridAcademic/Hospital1012014
Basque Country UniversityAcademic/Hospital1012014
Bristol-Myers SquibbFor profit101—
Cairo UniversityAcademic/Hospital1112023
Chinese Academy of Medical SciencesAcademic/Hospital1012024
Competence Network for Congenital Heart DefectsAcademic/Hospital1112007
124 organizations
Page 1 / 7

Marketing (18)

OrganizationOrg typeRelationshipDate
BaxaltaFor profitNDA2Sep 27, 1993
BaxterFor profitNDA2Sep 27, 1993
BaxterFor profitMKTGSep 26, 1996
Dr. Reddy's LaboratoriesFor profitMKTGMar 31, 1998
Eli LillyFor profitNDAJul 18, 1978
Hainan Poly PharmFor profitMKTGDec 21, 2022
HikmaFor profitMKTGOct 31, 1994
HospiraFor profitNDA2Sep 27, 1993
HospiraFor profitMKTGNov 29, 1993
LutipoldFor profitMKTGJun 25, 1998
SLATE RUN PHARMAFor profitMKTGDec 21, 2022
SankyoFor profitMKTGJun 25, 1998
Teligent PharmaceuticalsFor profitMKTGFeb 21, 1995
Teligent PharmaceuticalsFor profitSYNFeb 21, 1995
TevaFor profitMKTGOct 19, 1993
Watson PharmaceuticalsFor profitMKTGNov 30, 1993
Watson PharmaceuticalsFor profitSYNFeb 18, 1998
West-Ward PharmaceuticalFor profitMKTGOct 31, 1994