Overview
Perflutren, a diagnostic drug that is intended to be used for contrast enhancement during the indicated echocardiographic procedures, is comprised of lipid-coated microspheres filled with octafluoropropane(OFP) gas. When exposed to ultrasound waves, the microspheres resonate and "echo" strong signals back to the ultrasound machine. The difference in density between the gas-filled bubbles and the blood around them creates an increased level of contrast visible in the resulting ultrasound image. During echocardiography, activated Perflutren enhances images of the inner edges or borders of the heart, producing an improved image that may enable physicians to better diagnose patients.
Indication
Used as an ultrasound contrast imaging in cardiology and radiology.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/28 | Not Applicable | Recruiting | |||
2024/10/23 | Phase 4 | Recruiting | |||
2024/10/09 | Phase 1 | Recruiting | |||
2024/08/26 | Phase 2 | Recruiting | |||
2023/12/29 | Phase 2 | Not yet recruiting | |||
2023/12/14 | Phase 1 | Recruiting | |||
2023/09/06 | Phase 3 | Not yet recruiting | |||
2023/03/10 | Phase 2 | ENROLLING_BY_INVITATION | |||
2022/11/17 | Phase 1 | Recruiting | |||
2022/11/14 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Lantheus Medical Imaging, Inc. | 11994-017 | INTRAVENOUS | 6.52 mg in 1 mL | 3/13/2024 | |
| Lantheus Medical Imaging, Inc. | 11994-011 | INTRAVENOUS | 6.52 mg in 1 mL | 3/13/2024 | |
| GE Healthcare Inc. | 0407-2707 | INTRAVENOUS | 0.22 mg in 1 mL | 12/30/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/20/2006 | ||
Authorised | 5/17/1998 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Perflutren Lipid Microsphere Injection | 国药准字HJ20220082 | 化学药品 | 注射剂 | 11/15/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| OPTISON perflutren 660 microgram/3mL injection vial | 75247 | Medicine | A | 11/15/2000 | |
| DEFINITY perflutren lipid microsphere injection vial | 124808 | Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific | Medicine | A | 1/30/2007 |
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