Last reviewed · How we verify
Contrast agent: SonoVue®.
Contrast agent: SonoVue®. is a Ultrasound contrast agent Small molecule drug developed by Centre Hospitalier Régional Metz-Thionville. It is currently in Phase 3 development for Contrast-enhanced ultrasound imaging of the heart (left ventricular opacification), Contrast-enhanced ultrasound imaging of abdominal organs and vasculature. Also known as: hexafluoride.
SonoVue is a microbubble contrast agent that enhances ultrasound imaging by reflecting ultrasound waves, improving visualization of blood flow and tissue perfusion.
SonoVue is a microbubble contrast agent that enhances ultrasound imaging by reflecting ultrasound waves, improving visualization of blood flow and tissue perfusion. Used for Contrast-enhanced ultrasound imaging of the heart (left ventricular opacification), Contrast-enhanced ultrasound imaging of abdominal organs and vasculature.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Contrast agent: SonoVue®. |
|---|---|
| Also known as | hexafluoride |
| Sponsor | Centre Hospitalier Régional Metz-Thionville |
| Drug class | Ultrasound contrast agent |
| Modality | Small molecule |
| Therapeutic area | Diagnostic Imaging |
| Phase | Phase 3 |
Mechanism of action
SonoVue consists of sulfur hexafluoride microbubbles stabilized by a phospholipid shell. When injected intravenously, these microbubbles circulate through the vasculature and strongly reflect ultrasound waves due to their gas-liquid interface, creating enhanced contrast in ultrasound images. This allows improved visualization of perfusion in organs and tissues, particularly useful for cardiac, abdominal, and vascular imaging.
Approved indications
- Contrast-enhanced ultrasound imaging of the heart (left ventricular opacification)
- Contrast-enhanced ultrasound imaging of abdominal organs and vasculature
Common side effects
- Headache
- Nausea
- Chest discomfort
- Flushing
- Hypersensitivity reactions
Key clinical trials
- Interest of a Post-operative Ultrasound With Systematic Use of Ultrasonic Contrast in the Follow-up of Aortic Endoprosthesis: Prospective Study at the University Hospital of Nice (NA)
- Evaluation of Acute and Chronic Nephrotoxicity in Acute Lymphatic Leukemia Patients Using Ultrasound Localization Microscopy (NA)
- Placenta Accreta : Contrast-enhanced Ultrasound Analysis in High Risk Population (NA)
- 3D Contrast Enhanced Microvascular Ultrasound of Carotid Atherosclerosis for the Detection of Carotid Plaque Neo-Revascularisation. (NA)
- Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China
- Kidney Disease and Ultrasound Imaging (NA)
- Microflow3D - Non-invasive Mapping of Coronary Arteries and the Cerebral Vascular Network Using 3D Ultrasound Localization Microscopy in Patients With Atherosclerosis Prior to Carotid Endarterectomy Surgery (NA)
- Ultrasound Liver Intraoperative Imaging With SonoVue® (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:
- Contrast agent: SonoVue®. CI brief — competitive landscape report
- Contrast agent: SonoVue®. updates RSS · CI watch RSS
- Centre Hospitalier Régional Metz-Thionville portfolio CI
Frequently asked questions about Contrast agent: SonoVue®.
What is Contrast agent: SonoVue®.?
How does Contrast agent: SonoVue®. work?
What is Contrast agent: SonoVue®. used for?
Who makes Contrast agent: SonoVue®.?
Is Contrast agent: SonoVue®. also known as anything else?
What drug class is Contrast agent: SonoVue®. in?
What development phase is Contrast agent: SonoVue®. in?
What are the side effects of Contrast agent: SonoVue®.?
Related
- Drug class: All Ultrasound contrast agent drugs
- Manufacturer: Centre Hospitalier Régional Metz-Thionville — full pipeline
- Therapeutic area: All drugs in Diagnostic Imaging
- Indication: Drugs for Contrast-enhanced ultrasound imaging of the heart (left ventricular opacification)
- Indication: Drugs for Contrast-enhanced ultrasound imaging of abdominal organs and vasculature
- Also known as: hexafluoride
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing