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Dobutrex
Dobutrex is a Small molecule drug developed by Steen Hvitfeldt Poulsen. It is currently in Phase 1 development. Also known as: Dobutamine.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Dobutrex |
|---|---|
| Also known as | Dobutamine |
| Sponsor | Steen Hvitfeldt Poulsen |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Effect of Vitamin D Supplementation on Myocardial Regional Function by Dobutamine Stress Echocardiography in Diabetic Patients. (NA)
- Comparison of Dobutamine Stress Echocardiography and Fractional Flow Reserve in Patients With Moderate Coronary Artery Disease: Stable and Non-culprit Lesions Investigation (N/A)
- Can Dobutamine and Goal-Directed Fluid Therapy Improve Tissue Oxygenation in Deep Inferior Epigastric Perforator (DIEP) Flap Breast Reconstruction Surgery? Randomized Controlled Trial (Phase 1)
- Diagnostic Accuracy in Left Ventricular Systolic Dysfunction for Identifying Coronary Artery Disease With Dobutamine Versus Adenosine Non-invasive Stress Cardiac Magnetic Resonance Evaluation (NA)
- Study of the Performance of VCO2 Variation as an Indicator of Fluid Responsiveness in Intensive Care Unit (N/A)
- Efficacy of Levosimendan in the Critically Ill Patients With Unstable Hemodynamics (the LICI Study) - A Double Blind Randomized Pilot Study (Phase 2)
- The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients (NA)
- Randomized Study of Endovascular Versus Epicardial Lead Placement for Resynchronization Therapy (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dobutrex CI brief — competitive landscape report
- Dobutrex updates RSS · CI watch RSS
- Steen Hvitfeldt Poulsen portfolio CI
Frequently asked questions about Dobutrex
What is Dobutrex?
Who makes Dobutrex?
Is Dobutrex also known as anything else?
What development phase is Dobutrex in?
Related
- Manufacturer: Steen Hvitfeldt Poulsen — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Dobutamine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing