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perflutren lipid microspheres
perflutren lipid microspheres is a Ultrasound contrast agent Small molecule drug developed by University of Virginia. It is currently in Phase 3 development for Contrast enhancement for echocardiography. Also known as: Definity.
Perflutren lipid microspheres are ultrasound contrast agents that enhance the visibility of blood flow and cardiac function during echocardiography.
Perflutren lipid microspheres are a small molecule diagnostic agent used in ultrasound imaging. They have been studied in various clinical trials for conditions such as stress echocardiography, kidney obstruction, and liver neoplasms.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | perflutren lipid microspheres |
|---|---|
| Also known as | Definity |
| Sponsor | University of Virginia |
| Drug class | Ultrasound contrast agent |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
They work by encapsulating perflutren, a gas that is highly reflective of ultrasound waves, within lipid microspheres. When injected into the bloodstream, these microspheres accumulate in the left ventricle and are then cleared by the liver, allowing for improved visualization of cardiac structures and function.
Approved indications
- Contrast enhancement for echocardiography
Common side effects
- Hypersensitivity reactions
Key clinical trials
- Application of Contrast-enhanced Ultrasound in Monitoring Soft Tissue Sarcoma Response to Neoadjuvant Radiotherapy (EARLY_PHASE1)
- Prediction of Neoadjuvant Chemotherapy Response Using Contrast-Enhanced Ultrasound in Patients With Locally Advanced Breast Cancer (PHASE2, PHASE3)
- Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses (PHASE1)
- Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors
- NH002-mediated Sonoporation With Chemotherapy in Advanced Pancreatic Cancer (PHASE1)
- Ultrasound With Subharmonic Imaging and Subharmonic Aided Pressure Estimation (SHAPE) to Identify Portal Hypertension (NA)
- Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer (PHASE3)
- A Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography (PHASE1, PHASE2)
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:
- perflutren lipid microspheres CI brief — competitive landscape report
- perflutren lipid microspheres updates RSS · CI watch RSS
- University of Virginia portfolio CI
Frequently asked questions about perflutren lipid microspheres
What is perflutren lipid microspheres?
How does perflutren lipid microspheres work?
What is perflutren lipid microspheres used for?
Who makes perflutren lipid microspheres?
Is perflutren lipid microspheres also known as anything else?
What drug class is perflutren lipid microspheres in?
What development phase is perflutren lipid microspheres in?
What are the side effects of perflutren lipid microspheres?
Related
- Drug class: All Ultrasound contrast agent drugs
- Manufacturer: University of Virginia — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Contrast enhancement for echocardiography
- Also known as: Definity
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing