Drugs / Optison
Optison
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | OPTISON | — | 2012-08-17 – 2025-05-09 | fda.gov ↗ |
| Approved | EU (EMA) | Optison | — | 1998-05-17 | europa.eu ↗ |
| Approved | US (FDA) | OPTISON | — | 1997-12-31 | fda.gov ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05613946 | Dec 2022 → Jun 2024 | lymphedema | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT01763840 | Apr 2013 → Oct 2015 | — | David Mooney | Completed | No outcome recorded |
| Phase 1 | NCT00186953 | Jun 2002 → Aug 2004 | digestive system neoplasm | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT02204917 | Jul 2014 → Mar 2016 | vesicoureteral reflux | Kassa Darge | Completed | No outcome recorded |
| Phase 1/2 | NCT00286559 | Aug 2006 → Dec 2008 | coronary artery disorder | University Hospital, Basel, Switzerland | Withdrawn | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01489176 | Jul 2012 → Apr 2014 | coronary artery disorder, myocardial disorder | University of Nebraska | Completed | No outcome recorded |
| Phase 42 trials · 1 met primary | ||||||
| Phase 4 | NCT03740997 | Dec 2020 → Mar 2023 | cardiovascular disorder | GE Healthcare | Completed | Met primary |
| Phase 4 | NCT00878878 | Mar 2009 → Jul 2010 | pulmonary hypertension | GE Healthcare | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02170103 | Sep 2018 → Mar 2023 | ST-elevation myocardial infarction, intermediate coronary syndrome | University of Nebraska | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT02061163 Background | Feb 2015 → Jan 2017 | Crohn disease | University of Michigan | Withdrawn | No outcome recorded |
| — | NCT00580580 Comparator | Feb 2012 → Mar 2013 | carotid stenosis, coronary stenosis | University of Nebraska | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-05-13 | GE Healthcare | Regulatory GE HealthCare Announces FDA Approval of Pediatric Indication for Optison Ultrasound Enhancing Agent gehealthcare.com ↗
GE HealthCare (Nasdaq: GEHC) today announced the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for the company’s Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) ultrasound enhancing agent (UEA). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2025-05-13 | GE Healthcare | GE HealthCare Announces FDA Approval of Pediatric Indication for Optison Ultrasound Enhancing Agent gehealthcare.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Optison | “The contrast being used for the study is Optison (GE Healthcare Inc, Princeton, NJ), which is an injectable suspension of Perflutren Protein-Type A Microspheres.” NCT01763840 ↗10“OPTISON™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) manufactured by General Electric Global Research” NCT02170103 ↗ |
| Known as | OPTISON (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) manufactured by General Electric Global Research | “OPTISON™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) manufactured by General Electric Global Research” NCT02170103 ↗ |
| Modality | Diagnostic / imaging agent | “Optison Ultrasound Contrast Agent” NCT00186953 ↗ |
| Route | Intravenous | “The microspheres are injected into a peripheral or central vein.” NCT00286559 ↗ |