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Microbubble
Microbubble is a Small molecule drug developed by NaviFUS Corporation. It is currently in Phase 3 development. Also known as: SonoVue.
Microbubbles are bubbles smaller than one hundredth of a millimeter in diameter, but larger than one micrometer, with applications in various fields including medicine. They have been studied in clinical trials for conditions such as Type 1 Diabetes, Carotid Atherosclerosis, Patent Foramen Ovale, Gingivitis, and Colorectal Cancer, using interventions like Definity microbubbles and point-of-care ultrasound.
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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 | Microbubble |
|---|---|
| Also known as | SonoVue |
| Sponsor | NaviFUS Corporation |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy (PHASE1, PHASE2)
- Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer (PHASE2)
- Phase 4 Paediatric Study to Evaluate Sonazoid Safety and Efficacy for Contrast-Enhanced Ultrasound Liver Imaging (PHASE4)
- Sonoporation and Tumor Microenvironment Response in Colorectal Liver Metastases (NA)
- Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma (NA)
- Non-Invasive Detection of Right-to-Left Cardiac Shunts
- PlaCEUS: Feasibility Study of Contrast-enhanced Ultrasound to Visualize Maternal Uterine Spiral Arteries Postpartum. (NA)
- Can Tiny Bubbles Offer an Alternative to Catheters for Assessing Pressures Inside the Heart? Investigating Ultrasound Contrast Agents as Pressure Sensors Against Gold Standard Catheter Pressures in Cardiac Catheterisation Patients. (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:
- Microbubble CI brief — competitive landscape report
- Microbubble updates RSS · CI watch RSS
- NaviFUS Corporation portfolio CI
Frequently asked questions about Microbubble
What is Microbubble?
Who makes Microbubble?
Is Microbubble also known as anything else?
What development phase is Microbubble in?
Related
- Manufacturer: NaviFUS Corporation — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: SonoVue
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing