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 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 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 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 Stop: Business |
| Phase 1 | NCT00626873 | Jan 2007 → Feb 2012 | ovarian cancer | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07599865 | Aug 2026 → Jun 2029 expected | periprosthetic joint infection | Thomas Jefferson University | Recruiting | 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 | NCT03092089 | Aug 2017 → Oct 2019 | ST-elevation myocardial infarction | Harald Becher | Completed | No outcome recorded |
| Phase 2 | NCT01062178 | Oct 2009 → Oct 2012 | renal cell carcinoma | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 34 trials · 2 missed | ||||||
| Phase 3 | NCT05470205 | Nov 2022 → Feb 2028 expected | portal hypertension | Thomas Jefferson University | Recruiting | No outcome recorded |
| Phase 3 | NCT03719612 | Dec 2018 → Jan 2020 | heart disorder | Lantheus Medical Imaging | Completed | Missed primary |
| Phase 3 | NCT03571672 | Oct 2018 → Aug 2019 | heart disorder | Lantheus Medical Imaging | Completed | Missed primary |
| Phase 3 | NCT00000140 | Sep 1985 → ? | proliferative vitreoretinopathy, retinal detachment | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| 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 applicable6 trials | ||||||
| — | 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 |
| — | 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 |
| Comparator or background therapy22 trials | ||||||
| Phase 0 | NCT02384473 Background | Dec 2014 → Jan 2024 | bone sarcoma, retroperitoneal sarcoma | University of Southern California | Completed | No outcome recorded |
| 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 | NCT02067884 Background | Dec 2013 → Sep 2016 | breast cancer | University of Southern California | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03882359 Comparator | Apr 2019 → Sep 2024 | heart disorder | Microvascular Therapeutics, LLC | Completed | 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 2/3 | NCT05247541 Background | Jul 2020 → Mar 2023 | compartment syndrome | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 3 | NCT02764801 Background | Apr 2016 → Dec 2021 | hepatocellular carcinoma | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Completed | No outcome recorded |
| Phase 4 | NCT03544268 Background | Mar 2019 → May 2021 | — | UNC Lineberger Comprehensive Cancer Center | 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 |
| — | 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 |
| — | NCT01225016 Background | Oct 2010 → Dec 2011 | thyroid gland disorder | University of Alabama at Birmingham | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-03-04 | Lantheus Medical Imaging | Regulatory Lantheus Announces the FDA Approval of DEFINITY® (Perflutren Lipid Microsphere) for Pediatric Patients lantheus.com ↗
This approval represents a significant step forward in pediatric medicine, providing healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border. |
| 2022-11-28 | Lantheus Medical Imaging | Regulatory Lantheus Announces the Approval of DEFINITY® (Perflutren Lipid Microsphere) by China’s NMPA lantheus.com ↗
With this approval, DEFINITY is indicated in China for use in patients with suboptimal conventional echocardiography and to better identify the left ventricular endocardial border. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-03-04 | Lantheus Medical Imaging | Lantheus Announces the FDA Approval of DEFINITY® (Perflutren Lipid Microsphere) for Pediatric Patients lantheus.com ↗ |
| 2022-11-28 | Lantheus Medical Imaging | Lantheus Announces the Approval of DEFINITY® (Perflutren Lipid Microsphere) by China’s NMPA lantheus.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 50 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DEFINITY | “Myocardial contrast echocardiography will be performed by intravenous administration of ultrasound contrast agent (Definity or Lumason) using FDA-approved dose limits.” NCT02560467 ↗39“A combination of Definity microbubbles and clinically-relevant antibiotics will in injected into the intraarticular space of the knee the day after revision surgery.” 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 NCT02740868 ↗ |
| 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 Microsphere | “Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension” NCT00401687 ↗1“Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension” NCT07179328 ↗ |
| 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 ↗1“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 ↗ |