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 13 · a red edge is where a trial was stopped
| 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| Phase 1/2 | NCT00286559 | Aug 2006 → Dec 2008 | coronary artery disorder | University Hospital, Basel, Switzerland | Withdrawn | No outcome recorded |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 22 trials | ||||||
| Phase 2 | NCT05328167 | Dec 2021 → Jul 2025 | intrahepatic cholangiocarcinoma | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 2 | NCT03199274 | Jul 2017 → Feb 2024 | hepatocellular carcinoma | Thomas Jefferson University | Completed | 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 43 trials | ||||||
| Phase 4 | NCT03740997 | Dec 2020 → Mar 2023 | cardiovascular disorder | GE Healthcare | Completed | No outcome recorded |
| Phase 4 | NCT00878878 | Mar 2009 → Jul 2010 | pulmonary hypertension | GE Healthcare | Completed | No outcome recorded |
| Phase 4 | NCT00730964 | May 2008 → Oct 2009 | — | GE Healthcare | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02170103 | Sep 2018 → Mar 2023 | ST-elevation myocardial infarction, intermediate coronary syndrome | University of Nebraska | Completed | No outcome recorded |
| — | NCT00239525 | May 2006 → Apr 2007 | intracranial hypertension, stroke disorder | Duke University | Completed | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02671552 Background | Jan 2013 → Dec 2014 | renal cell carcinoma | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Withdrawn | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02061163 Background | Feb 2015 → Jan 2017 | Crohn disease | University of Michigan | Withdrawn | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00580580 Comparator | Feb 2012 → Mar 2013 | carotid stenosis, coronary stenosis | University of Nebraska | Withdrawn | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 16 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 ↗ |
| Known as | Perflutren Protein-Type A Microspheres | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05328167 ↗ |
| Modality | Diagnostic / imaging agent | “Optison Ultrasound Contrast Agent” NCT00186953 ↗ |
| Route | Intravenous | “by intravenous bolus injection” NCT00239525 ↗ |