Drugs / Definity
Definity
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | DEFINITY | — | 2011-10-24 – 2024-03-01 | fda.gov ↗ |
| Approved | US (FDA) | DEFINITY | — | 2001-07-31 | fda.gov ↗ |
| Approved | EU (EMA) | Optison | — | 1998-05-17 | europa.eu ↗ |
Trials 44 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT07436364 | Mar 2026 → May 2027 expected | soft tissue sarcoma | Thomas Jefferson University | Recruiting | No outcome recorded |
| Phase 0 | NCT07050836 | Dec 2025 → Jan 2026 | brain glioma | University of Colorado, Denver | Terminated | No outcome recorded |
| Phase 0 | NCT01751529 | May 2013 → Nov 2015 | kidney cancer | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT05613946 | Dec 2022 → Jun 2024 | lymphedema | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT05620290 | Jun 2022 → Jul 2025 overdue | melanoma | Sunnybrook Health Sciences Centre | Recruiting | No outcome recorded |
| Phase 1 | NCT04431674 | Jul 2020 → Jun 2023 | breast cancer | Sunnybrook Health Sciences Centre | Completed | No outcome recorded |
| Phase 1 | NCT04431648 | May 2020 → May 2024 | head and neck cancer | Sunnybrook Health Sciences Centre | Unknown | No outcome recorded |
| Phase 1 | NCT00955097 | May 2008 → Jun 2009 | liver cancer | University of Louisville | Terminated | No outcome recorded |
| Phase 1 | NCT00626873 | Jan 2007 → Feb 2012 | ovarian cancer | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00507806 | Mar 2005 → May 2006 | ischemic stroke | ImaRx Therapeutics | Terminated | No outcome recorded |
| Phase 211 trials | ||||||
| Phase 2 | NCT07599865 | Jun 2026 → Jun 2028 expected | periprosthetic joint infection | Thomas Jefferson University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06571786 | Dec 2024 → Jul 2025 | — | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 2 | NCT06185972 | Jul 2024 → Feb 2026 overdue | breast cancer | Sunnybrook Health Sciences Centre | Recruiting | No outcome recorded |
| Phase 2 | NCT05090800 | Dec 2021 → Sep 2025 | obstructive nephropathy | University of Michigan | Completed | No outcome recorded |
| Phase 2 | NCT04021238 | Oct 2020 → Aug 2022 | kidney cancer | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03907657 | Sep 2019 → Mar 2023 | chronic kidney disease, von Hippel-Lindau disease | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03196076 | Aug 2017 → Mar 2021 | chronic kidney disease, cystic kidney disease | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT03092089 | Aug 2017 → Oct 2019 | ST-elevation myocardial infarction | Harald Becher | Completed | No outcome recorded |
| Phase 2 | NCT02967458 | Feb 2017 → Feb 2018 | prostate neoplasm | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 2 | NCT02684435 | Feb 2016 → Jul 2018 | chronic kidney disease, cystic kidney disease | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT01062178 | Oct 2009 → Oct 2012 | renal cell carcinoma | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT06024772 | Jul → Aug 2026 overdue | prostate carcinoma | Thomas Jefferson University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05470205 | Nov 2022 → Feb 2026 overdue | portal hypertension | Thomas Jefferson University | Recruiting | No outcome recorded |
| Phase 3 | NCT05336786 | Jun 2022 → May 2025 overdue | prostate carcinoma | Thomas Jefferson University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03719612 | Dec 2018 → Jan 2020 | heart disorder | Lantheus Medical Imaging | Completed | No outcome recorded |
| Phase 3 | NCT03571672 | Oct 2018 → Aug 2019 | heart disorder | Lantheus Medical Imaging | Completed | No outcome recorded |
| Phase 3 | NCT00000140 | Sep 1985 → ? | proliferative vitreoretinopathy, retinal detachment | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT06654804 | Sep 2023 → Sep 2027 expected | spinal cord injury | University of Washington | Recruiting | No outcome recorded |
| Phase 4 | NCT02880137 | Sep 2016 → Jun 2018 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT01490892 | Nov 2011 → Apr 2019 | breast cancer | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 4 | NCT00918866 | Jul → Dec 2009 | chronic pulmonary heart disease | Lantheus Medical Imaging | Completed | No outcome recorded |
| Phase 4 | NCT00625365 | Feb 2008 → May 2009 | cardiovascular disorder | Lantheus Medical Imaging | Completed | No outcome recorded |
| Phase 4 | NCT00401687 | Jul 2006 → Jun 2007 | — | Lantheus Medical Imaging | Completed | No outcome recorded |
| Phase not applicable11 trials | ||||||
| — | NCT06797193 | Mar 2025 → Mar 2027 expected | portal hypertension | Mayo Clinic | Recruiting | No outcome recorded |
| — | NCT02170103 | Sep 2018 → Mar 2023 | ST-elevation myocardial infarction, intermediate coronary syndrome | University of Nebraska | Completed | No outcome recorded |
| — | NCT03203239 | Jan 2018 → Dec 2028 expected | intermittent vascular claudication, isoproterenol-mediated vasodilatation, peripheral arterial disease | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| — | NCT03300401 | Nov 2017 → Nov 2019 | hepatocellular carcinoma | University of Southern California | Withdrawn | No outcome recorded |
| — | NCT01894607 | Oct 2013 → Dec 2014 | kidney cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| — | NCT03212326 | Mar 2013 → Sep 2018 | cardiomyopathy, ventricular tachycardia | Weill Medical College of Cornell University | Completed | No outcome recorded |
| — | NCT01526590 | Jul 2012 → Jul 2013 | pancreatic neoplasm | University of Vermont | Withdrawn | No outcome recorded |
| — | NCT01544036 | Feb 2012 → Feb 2014 | acute kidney injury | University of Virginia | Unknown | No outcome recorded |
| — | NCT01391039 | Sep 2011 → Jul 2015 | ductal breast carcinoma in situ | Sunnybrook Health Sciences Centre | Terminated | No outcome recorded |
| — | NCT00584402 | Apr 2007 → Mar 2009 | liver and intrahepatic bile duct neoplasm | University of California, Davis | Completed | No outcome recorded |
| — | NCT00631553 | Jun 2006 → Dec 2009 | kidney disorder | University of Virginia | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 30 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT04721886 Background | Nov 2020 → Jul 2023 | breast carcinoma | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 0 | NCT03297112 Background | Aug 2017 → Sep 2018 | reproductive system neoplasm | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Completed | No outcome recorded |
| Phase 0 | NCT02384473 Background | Dec 2014 → Jan 2024 | bone sarcoma, retroperitoneal sarcoma | University of Southern California | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT07501650 Background | Mar 2026 → Mar 2027 expected | head and neck cancer, small cell carcinoma | Thomas Jefferson University | Recruiting | No outcome recorded |
| Phase 1 | NCT07179328 Background | Jun 2025 → Jul 2027 expected | brain glioblastoma, primary brain neoplasm | Sunnybrook Health Sciences Centre | Recruiting | No outcome recorded |
| Phase 1 | NCT06171607 Background | Nov 2020 → Nov 2026 expected | breast carcinoma | University of Southern California | Recruiting | No outcome recorded |
| Phase 1 | NCT02067884 Background | Dec 2013 → Sep 2016 | breast cancer | University of Southern California | Terminated | No outcome recorded |
| Phase 1 | NCT03045497 Background | Dec 2012 → Dec 2013 | hepatocellular carcinoma | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03882359 Comparator | Apr 2019 → Sep 2024 | heart disorder | Microvascular Therapeutics, LLC | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07225114 Background | Nov 2025 → Dec 2028 expected | breast cancer, kidney neoplasm, liver and intrahepatic bile duct neoplasm | UNC Lineberger Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05764642 Background | Aug 2023 → Apr 2028 expected | chronic kidney disease | Mayo Clinic | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT04136912 Background | May 2022 → Aug 2024 | breast cancer, thyroid cancer | UNC Lineberger Comprehensive Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT04217304 Background | Feb 2021 → Jan 2026 | ST-elevation myocardial infarction | University of Alberta | Terminated | No outcome recorded |
| Phase 2 | NCT03243942 Background | Jun 2017 → Jun 2019 | heart failure | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 2 | NCT02740868 Comparator | Aug 2015 → Dec 2026 expected | asthma, cystic fibrosis | The Hospital for Sick Children | Recruiting | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04715958 Background | Dec 2020 → Oct 2026 expected | breast carcinoma | Kibo Nam | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05247541 Background | Jul 2020 → Mar 2023 | compartment syndrome | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02764801 Background | Apr 2016 → Dec 2021 | hepatocellular carcinoma | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT03544268 Background | Mar 2019 → May 2021 | — | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 4 | NCT04056988 Background | Jul 2018 → Nov 2023 | spinal cord injury | University of Washington | Completed | No outcome recorded |
| Phase 4 | NCT02102243 Background | Nov 2010 → Dec 2025 | hypertensive disorder | Wanpen Vongpatanasin | Withdrawn | No outcome recorded |
| Phase 4 | NCT00162370 Background | Apr 2004 → Sep 2012 | coronary artery disorder | Lantheus Medical Imaging | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT04118764 Background | Aug 2020 → Jul 2022 | Alzheimer disease | Columbia University | Completed | No outcome recorded |
| — | NCT02560467 Background | Dec 2015 → Sep 2019 | hypertrophic cardiomyopathy | Oregon Health and Science University | Unknown | No outcome recorded |
| — | NCT02424955 Background | Nov 2014 → Jun 2022 | hepatocellular carcinoma | Stanford University | Completed | No outcome recorded |
| — | NCT02115607 Background | Mar 2014 → May 2018 | breast cancer | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Completed | No outcome recorded |
| — | NCT01631318 Background | Nov 2012 → Aug 2020 | colon carcinoma, metastasis from malignant tumor of colon | Stanford University | Completed | No outcome recorded |
| — | NCT00580580 Comparator | Feb 2012 → Mar 2013 | carotid stenosis, coronary stenosis | University of Nebraska | Withdrawn | No outcome recorded |
| — | NCT01242020 Background | Jan → May 2011 | obesity disorder | University of Pennsylvania | Terminated | No outcome recorded |
| — | NCT01225016 Background | Oct 2010 → Dec 2011 | thyroid gland disorder | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 75 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Definity | “The purpose of this study is to determine the efficacy of the Definity (perflutren lipid microsphere Injectable Suspension) ultrasound contrast agent in identifying small tumors” NCT00584402 ↗40“Myocardial contrast echocardiography will be performed by intravenous administration of ultrasound contrast agent (Definity or Lumason) using FDA-approved dose limits.” NCT02560467 ↗ “and Definity microbubbles to perform the UTMD therapy using commercially-available flash-replenishment sequences.” NCT07599865 ↗ “DEFINITY® (Perflutren Lipid Microsphere) manufactured by Lantheus Medical Imaging” NCT02170103 ↗ “Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]” NCT03212326 ↗ “a bolus IV injection of up to 0.6 ml of Definity” NCT02764801 ↗ |
| Known as | C3F8 | “silicone oil versus perfluropropane (C3F8) gas tamponades” PMID 32408387 ↗ May 2020 |
| Known as | DEFINITY (Perflutren Lipid Microsphere) manufactured by Lantheus Medical Imaging | “DEFINITY® (Perflutren Lipid Microsphere) manufactured by Lantheus Medical Imaging” NCT02170103 ↗ |
| Known as | Definity ultrasound contrast | “Definity ultrasound contrast” NCT01526590 ↗ |
| Known as | Octafluoropropane | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03203239 ↗ |
| Known as | Perfluoropropane | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00000140 ↗ |
| Known as | Perflutren | “Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)” NCT01490892 ↗6“Perflutren is a diagnostic drug that is intended to be used for contrast enhancement.” NCT03544268 ↗ |
| Known as | Perflutren Injectable Microbubbles | “DEFINITY® Perflutren Injectable Microbubbles is an ultrasound contrast imaging agent” NCT07179328 ↗ |
| Known as | perflutren lipid | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07225114 ↗ |
| Known as | Perflutren Lipid Microcpheres | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04721886 ↗ |
| Known as | Perflutren Lipid Microsphere | “Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension” NCT07179328 ↗13“Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension” NCT00401687 ↗ |
| Known as | perflutren lipid microspheres | “Definity (perflutren lipid microspheres, Lantheus Medical Imaging) is an ultrasound contrast indicated for use in patients with suboptimal echocardiograms to opacify the left...” NCT03882359 ↗10“Drug: perflutren lipid microspheres” NCT02424955 ↗ |
| Modality | Diagnostic / imaging agent | “All patients will receive DEFINITY at rest and stress to enhance wall motion assessment.” NCT00162370 ↗ |
| Route | Other | “intraocular long-acting gas” NCT00000140 ↗ |