Dobutrex

(Dobutamine)

ApprovedSmall molecule

Dobutamine is used to help strengthen the heart's contractions and improve blood flow in patients with heart failure or after heart surgery. It's typically given as an injection in a hospital setting to support the heart when it's not pumping effectively on its own.[2] Dobutrex is currently approved and in use across 14 indications[4].[1]

Dobutrex is one of 342 small molecule programs targeting Metabolic Syndrome. It is currently in Approved.

Indications

Total Trials

Active Trials

341

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Metabolic SyndromeActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Aortic StenosisActive, not recruiting

ShockApproved

Brain InjuryApproved

Abnormality of the Cardiovascular SystemActive, not recruiting

SepsisNot yet recruiting

EncephalopathyActive, not recruiting

BurnApproved

Heart FailureUnknown status

Metabolic SyndromePreclinical

Active, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Aortic StenosisPreclinical

Active, not recruiting

ShockApproved

Approved

Brain InjuryApproved

Approved

Abnormality of the Cardiovascular SystemPreclinical

Active, not recruiting

SepsisPhase 2

Not yet recruiting

EncephalopathyPreclinical

Active, not recruiting

BurnApproved

Approved

Heart FailureApproved

Unknown status

Showing 10 of 14 indications

Competition

Competitive Landscape

198 competitors in Heart Failure

#DrugCompanyPhaseTrials

Dobutrex

Pfizer

Approved

5 2

Activase

Zemplar

Xylocaine

1 5

Potassium Iodide

MMeda Pharmaceuticals

Preclinical

1 6

Oraverse

LLife Extension Foundation Inc.

Preclinical

1 7

Optimal Medical Therapy

HHelios Health Institute GmbH

Preclinical

2 8

Jardiance

Boehringer Ingelheim

Preclinical

2 9

Sulfonylureas

Eli Lilly

Preclinical

1 10

SGLT2 Inhibitors

PPharmaceuticals and Medical Devices Agency, Japan

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Cardiogenic Shock

NCT05267886

N/ARecruiting

CAR

NCT05944146

Q2 2029

Phase 2Recruiting

Hypoxic-Ischemic Encephalopathy (HIE)

NCT07406477

Clinical

Trials by Indication[1]

Heart Failure5 trials

Reduced Contractile Reserve: a Therapeutic Target in Heart Failure With Preserved Ejection Fraction(HFpEF)

Completed·UUniversity of Wisconsin, Madison·N/A·NCT01354613·14 enrolled

Levosimendan Versus Dobutamine for Renal Function in Heart Failure

Completed·GGöteborg University·Phase 3·NCT02133105·33 enrolled

Intravenous Vasodilator vs. Inotropic Therapy in Patients With Heart Failure

Withdrawn·MMontefiore Medical Center·Phase 4·NCT02767024

Show 2 more trials

Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.

Completed·AAbbott·Phase 3·NCT00348504·1,300 enrolled

Outcome and Safety of Intermittent Dobutamine Infusion at a Day-Care Center in Advanced Heart Failure Patients

Unknown status·SSheba Medical Center·Phase 4·NCT01930734·60 enrolled

Septic Shock4 trials

Effects of Dobutamine on Microcirculation, Regional and Peripheral Perfusion in Septic Shock Patients

Completed·PPontificia Universidad Catolica de Chile·N/A·NCT01271153·20 enrolled

Dobutamine for Management of Surgical Patients With Septic Shock

Completed·FFirst Affiliated Hospital of Zhejiang University·N/A·NCT06462313·584 enrolled

Effects of Levosimendan on Microcirculation in Septic Shock

Completed·UUniversity of Roma La Sapienza·Phase 2·NCT00800306·40 enrolled

Show 1 more trial

Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock

Unknown status·MMilitary Hospital of Tunis·N/A·NCT02963454·50 enrolled

Cardiogenic Shock2 trials

CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

Recruiting·OOttawa Heart Institute Research Corporation·Phase 4·NCT05267886·346 enrolled

Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support

Unknown status·TThe Young Investigator Group of Cardiovascular Research·Phase 3·NCT05594342·200 enrolled

Sepsis2 trials

Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis

Unknown status·OOnze Lieve Vrouwe Gasthuis·Phase 4·NCT00484133·80 enrolled

Use of Dobutamine in Patients With Sepsis and Maintained Hypoperfusion After Initial Volemic Resuscitation.

Not yet recruiting·FFederal University of São Paulo·Phase 2·NCT05953142·120 enrolled

Cardiac2 trials

Comparison of Dobutamine and Regadenoson Stress Cardiac Magnetic Resonance (MR)

Terminated·WWake Forest University Health Sciences·Phase 1·NCT00763035·14 enrolled

Dobutamine on the Cardiac Conduction System

Completed·NNorthwell Health·Phase 1·NCT04249258·37 enrolled

30 more indications

Newborns1 trial

Dobutamine Versus Placebo for Low Superior Vena Cava Flow in Newborns

Completed·AAdelina Pellicer·Phase 2·NCT01605279·127 enrolled

Breast Reconstruction1 trial

Improving Tissue Oxygenation in Breast Reconstruction Surgery

Completed·—·Phase 1/2·NCT04020172·40 enrolled

Colorectal Surgery1 trial

Non-invasive Early Goal Directed Therapy in Colorectal Surgery: a Feasibility Study

Completed·UUniversity Hospital Schleswig-Holstein·N/A·NCT02559141·80 enrolled

Cirrhosis1 trial

DOCICAR: Cardiac Dysfunction in Cirrhosis

Completed·HHvidovre University Hospital··NCT00250315

Encephalopathy1 trial

NeoAdapt 3: Novel Biomarkers in the Evaluation of Neonatal Circulatory Insufficiency in Babies Suffering From Hypoxic Ischemic Encephalopathy

Completed·—··NCT02051894·18 enrolled

Fluid Resuscitation1 trial

Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Free Flaps

Completed·SSzeged University·N/A·NCT03288051·30 enrolled

Acute Myocardial Infarction1 trial

Low-Dose Dobutamine and Single-Dose Tocilizumab in Acute Myocardial Infarction With High Risk of Cardiogenic Shock

Active, not recruiting·RRigshospitalet, Denmark·Phase 2·NCT05350592·100 enrolled

Critically Ill Patients1 trial

Milrinone Versus Dobutamine in Critically Ill Patients

Completed·OOttawa Heart Institute Research Corporation·Phase 4·NCT03207165·192 enrolled

Shock1 trial

Levosimendan Versus Dobutamine in Shock Patients

Unknown status·WWentworth Area Health Services·Phase 2/3·NCT00093301·40 enrolled

Acute Lung Injury1 trial

Hemodynamics and Extravascular Lung Water in Acute Lung Injury

Completed·OOregon Health and Science University·Phase 2·NCT00624650·33 enrolled

Function1 trial

Haemodynamic Effects of Dobutamine and Nitrite in LV Dysfunction

Unknown status·KKing's College London··NCT02888561·45 enrolled

Pediatric Patients1 trial

Dobutamine Versus Milrinone in Management of Critically Ill Low Cardiac Output Pediatric Patients at Cairo University Children's Hospital

Unknown status·—·N/A·NCT05999487·40 enrolled

Hypotension1 trial

Dopamine Versus Dobutamine for Treatment of Arterial Hypotension in Term and Preterm Neonates

Unknown status·UUniversity of Ulm·Phase 4·NCT01427686·20 enrolled

Mitral Valve Surgery1 trial

The Effects of Levosimendan During Mitral Valve Surgery

Completed·KKartal Kosuyolu Yuksek Ihtisas Education and Research Hospital·Phase 4·NCT01969071·140 enrolled

CAR1 trial

Consistency of Carotid Doppler Blood Flow and Thermodilution Technique

Recruiting·SShanghai Zhongshan Hospital·N/A·NCT05944146·200 enrolled

Major Abdominal Surgery1 trial

Dobutamine During Major Abdominal Surgery

Recruiting·UUniversity of Hamburg-Eppendorf·N/A·NCT07000994·100 enrolled

Cardiac Surgery1 trial

Levosimendan Versus Dobutamine in Cardiopatic Patients Undergoing Major Non Cardiac Surgery

Unknown status·AAzienda Policlinico Umberto I·Phase 4·NCT02012946·40 enrolled

Blood Pressure1 trial

Decision Support for Intraoperative Low Blood Pressure

Completed·VVanderbilt University Medical Center·N/A·NCT02726620·22,435 enrolled

Aortic Valve Replacement1 trial

The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement

Suspended·UUniversity of Aarhus·Phase 4·NCT01375335·10 enrolled

Treatment1 trial

Dobutamine in the Treatment of Haemodynamic Insufficiency in the Immediate Postnatal Period

Terminated·FFundacion para la Investigacion Biomedica del Hospital Universitario la Paz·Phase 1/2·NCT03311178·15 enrolled

AIN1 trial

Dobutamaine Versus Milrinone in Cardiorenal Syndrome

Withdrawn·MMaimonides Medical Center·Phase 2·NCT02644057

Aortic Stenosis1 trial

Novel Echocardiographic and Invasive Haemodynamic Measurements in the Assessment of Patients Low Flow Low Gradient Aortic Stenosis Undergoing TAVI

Completed·TThe Royal Wolverhampton Hospitals NHS Trust·N/A·NCT05196815·7 enrolled

Surgery1 trial

Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery

Completed·OOxford University Hospitals NHS Trust·Phase 4·NCT01418118·25 enrolled

Dilated Cardiomyopathy1 trial

Intravenous Allopurinol to Improve Heart Function in Individuals With Dilated Cardiomyopathy

Withdrawn·UUniversity of Pennsylvania·Phase 1/2·NCT00281255

Severe Burns1 trial

Supernormal Oxygen Delivery for Patients With Severe Burns

Unknown status·—·Phase 1·NCT05241912·100 enrolled

Cardiomyopathy1 trial

Adjunctive DobutAmine in sePtic Cardiomyopathy With Tissue Hypoperfusion

Completed·UUniversity Hospital, Limoges·Phase 3·NCT04166331·136 enrolled

Metabolic Syndrome1 trial

Myocardial Regional Function by Dobutamine Stress Echocardiography in the Metabolic Syndrome and Type 2 Diabetes

Completed·—·N/A·NCT02505451·125 enrolled

Hypoxic-ischemic Encephalopathy (HIE)1 trial

The PROTECT-HIE Pilot Trial: Prophylactic Therapy to Enhance Cardiovascular Treatment in Neonatal Hypoxemic Ischemic Encephalopathy

Recruiting·UUniversity of Alberta·Phase 2·NCT07406477·40 enrolled

Acute Decompensated Heart Failure (ADHF)1 trial

Clinical Outcomes of Levosimendan Versus Dobutamine Versus Milrinone in Cases With Acute Decompensated Heart Failure With Impaired Renal Function

Completed·AAin Shams University·Approved·NCT07186062·60 enrolled

Unspecified2 trials

Influence of Continuous Administration of Phenylephrine Versus Dobutamine on Spinal Oxygen Saturation, Measured With Near-infrared Spectroscopy (NIRS).

Completed·UUniversity Hospital, Ghent·Phase 4·NCT03846765·36 enrolled

Right Ventricular Contractile Reserve in HF

Unknown status·IIstituto Auxologico Italiano·N/A·NCT05797584·60 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

DOBUTREX

NDA NDA017820

Oct 19, 1993

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

NDA NDA020269

Oct 19, 1993

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

NDA NDA020255

Oct 19, 1993

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

NDA NDA020201

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for Dobutamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Dobutrex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Dobutamine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Dobutamine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020269). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Beta-2 Adrenergic Receptor Agonist; Beta-1 Adrenergic Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Dobutrex

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2029

Trials by Indication[1]

Heart Failure5 trials

Septic Shock4 trials

Cardiogenic Shock2 trials

Sepsis2 trials

Cardiac2 trials

Newborns1 trial

Breast Reconstruction1 trial

Colorectal Surgery1 trial

Cirrhosis1 trial

Encephalopathy1 trial

Fluid Resuscitation1 trial

Acute Myocardial Infarction1 trial

Critically Ill Patients1 trial

Shock1 trial

Acute Lung Injury1 trial

Function1 trial

Pediatric Patients1 trial

Hypotension1 trial

Mitral Valve Surgery1 trial

CAR1 trial

Major Abdominal Surgery1 trial

Cardiac Surgery1 trial

Blood Pressure1 trial

Aortic Valve Replacement1 trial

Treatment1 trial

AIN1 trial

Aortic Stenosis1 trial

Surgery1 trial

Dilated Cardiomyopathy1 trial

Severe Burns1 trial

Cardiomyopathy1 trial

Metabolic Syndrome1 trial

Hypoxic-ischemic Encephalopathy (HIE)1 trial

Acute Decompensated Heart Failure (ADHF)1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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