NDAINJECTIONINJECTABLE
Approved
Dec 1997
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
6
Data completeness
4/8 — Partial
OPTISON (human albumin microspheres and perflutren) by GE HealthCare is ultrasound contrast activity [moa]. Approved for contrast agent for ultrasound imaging [epc]. First approved in 1997.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPTISON is an injectable ultrasound contrast agent composed of human albumin microspheres and perflutren gas, used to enhance echocardiographic imaging and left ventricular opacification. It works by creating acoustic backscatter during ultrasound examinations, improving visualization of cardiac structures and blood flow. The product enables clinicians to better assess cardiac function and detect abnormalities in patients undergoing echocardiography.
LOE Approaching2.0 years to LOE
With LOE approaching in 2028, the OPTISON brand team is likely contracting and shifting focus toward retention and lifecycle management strategies.
Mechanism of Action
Ultrasound Contrast Activity
Pharmacologic Class:
Contrast Agent for Ultrasound Imaging
Indications (1)
Clinical Trials (6)
Study to Determine Safety and Dosage of OPTISON in Pediatric Participants
Started Dec 2020
39 enrolled
Transthoracic EchocardiographySuspected or Known Structural or Functional Cardiac Abnormality
The Role of Echocardiographic Contrast (Optison) in Enhancing Tricuspid Regurgitation Spectral Doppler Signals
Started Jun 2015
0Hypertension, Pulmonary
Regadenoson Real Time Perfusion Imaging Trial-Optison
Started Jul 2012
50 enrolled
Coronary Artery DiseaseMyocardial Perfusion Abnormalities
Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease
Started Jun 2011
21 enrolled
Carotid Artery Disease
Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).
Started Mar 2009
30 enrolled
Pulmonary Hypertension
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.