Drugs / Regadenoson
Regadenoson
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LEXISCAN | — | 2017-01-17 | fda.gov ↗ |
| Approved | EU (EMA) | Rapiscan | — | 2010-09-06 | europa.eu ↗ |
| Approved | US (FDA) | LEXISCAN | — | 2008-04-10 | fda.gov ↗ |
Trials 31 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT04521569 | Jun 2020 → Jun 2024 | — | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 0 | NCT02389738 | Feb 2015 → Feb 2016 | — | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 0 | NCT00881218 | Jun 2009 → Dec 2011 | myocardial ischemia | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT03971734 | Dec 2019 → Apr 2022 | anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded |
| Phase 1 | NCT03072589 | Nov 2017 → Aug 2021 | — | Christine Lau, MD | Unknown | No outcome recorded |
| Phase 1 | NCT01918995 | May → Aug 2013 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01161121 | Jul 2010 → Apr 2013 | coronary artery disorder | St. Louis University | Completed | No outcome recorded |
| Phase 1 | NCT01085201 | Apr 2010 → Feb 2013 | sickle cell disease | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04604782 | May 2021 → Dec 2026 expected | coronary artery disorder, myocardial ischemia | GE Healthcare | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04606069 | May 2021 → Apr 2023 | COVID-19, pneumonitis | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03090087 | Mar → Nov 2017 | retinal artery occlusion | University of Aarhus | Unknown | No outcome recorded |
| Phase 2 | NCT01710254 | Jan 2013 → Oct 2016 | atrial fibrillation, coronary artery disorder | University of Utah | Completed | No outcome recorded |
| Phase 2 | NCT00907764 | Apr 2009 → Apr 2010 | coronary artery disorder | Gilead Sciences | Terminated | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT01489176 | Jul 2012 → Apr 2014 | coronary artery disorder, myocardial disorder | University of Nebraska | Completed | No outcome recorded |
| Phase 3 | NCT01618669 | Jun 2012 → Dec 2014 | coronary artery disorder | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00208312 | Apr 2004 → Jun 2005 | coronary artery disorder | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00208299 | Oct 2003 → Aug 2006 | coronary artery disorder | Gilead Sciences | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT02589977 | Nov 2015 → Jan 2020 | diastolic heart failure, hypertensive disorder | Marvin W. Kronenberg, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT02115308 | Sep 2014 → Jan 2018 | coronary artery disorder | Timothy M. Bateman | Completed | No outcome recorded |
| Phase 4 | NCT01446094 | Aug 2011 → Jun 2018 | coronary artery disorder | Dipan Shah | Unknown | No outcome recorded |
| Phase 4 | NCT01019486 | Nov 2009 → Dec 2011 | coronary artery disorder, type 1 diabetes mellitus | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 4 | NCT00863707 | Apr → Dec 2009 | chronic kidney disease, coronary artery disorder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00862641 | Apr → Oct 2009 | asthma, chronic obstructive pulmonary disease, coronary artery disorder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00871260 | Apr 2009 → Jun 2014 | coronary artery disorder | University of Chicago | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT02220634 | Aug 2014 → May 2017 | pulmonary hypertension | National Jewish Health | Terminated | No outcome recorded |
| — | NCT01842035 | Feb 2013 → Apr 2020 | sudden arrhythmia death syndrome, systolic heart failure | University of Alabama at Birmingham | Completed | No outcome recorded |
| — | NCT01566890 | Jul 2012 → Jul 2019 | sickle cell disease | Versiti Blood Health | Completed | No outcome recorded |
| — | NCT01482169 | Mar 2012 → May 2014 | coronary artery disorder | Ochsner Health System | Completed | No outcome recorded |
| — | NCT01021618 | Jan 2010 → Mar 2012 | coronary artery disorder, myocardial ischemia | Hartford Hospital | Completed | No outcome recorded |
| — | NCT01026012 | Dec 2009 → Sep 2010 | — | University of Maryland, Baltimore | Completed | No outcome recorded |
| — | NCT00859833 | Feb 2009 → Jul 2010 | obesity disorder | University of Utah | Completed | No outcome recorded |
Also used as a comparator or background therapy in 28 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04600115 Background | Mar 2017 → Mar 2027 expected | MRI defined brain infarct | University of Utah | Recruiting | No outcome recorded |
| Phase 0 | NCT00763035 Comparator | Jan 2009 → Dec 2010 | asthma, chronic obstructive pulmonary disease, intermediate coronary syndrome | Wake Forest University Health Sciences | Terminated | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT01433705 Background | Nov 2011 → Jan 2018 | heart disorder | University of Michigan | Completed | No outcome recorded |
| Phase 1 | NCT00837369 Background | Apr 2009 → Mar 2011 | coronary artery disorder | University of Nebraska | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT05583721 Background | Oct 2023 → Sep 2027 expected | sickle cell disease | St. Jude Children's Research Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT03103061 Background | Feb 2016 → Jun 2018 | coronary artery disorder | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 2 | NCT01840696 Background | Oct 2013 → May 2014 | coronary artery disorder | Emory University | Withdrawn | No outcome recorded |
| Phase 2 | NCT01788631 Comparator | Jul 2013 → Nov 2016 | sickle cell disease | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT01655043 Background | Sep 2012 → Feb 2014 | myocardial ischemia | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT01334918 Background | Apr 2011 → Jul 2012 | coronary artery disorder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT03354273 Background | Jun 2018 → May 2022 | coronary artery disorder | GE Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT01809743 Comparator | Jan → Oct 2013 | coronary artery disorder | Lokien van Nunen | Completed | No outcome recorded |
| Phase 3 | NCT00826280 Background | Mar 2009 → Jul 2010 | coronary artery disorder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT03102125 Background | Oct 2019 → Jan 2027 expected | transplant rejection | Paul Kim | Recruiting | No outcome recorded |
| Phase 4 | NCT03249272 Comparator | Sep 2017 → Mar 2019 | coronary microvascular disorder, dilated cardiomyopathy, hypertrophic cardiomyopathy | Duke University | Terminated | No outcome recorded |
| Phase 4 | NCT02597543 Background | Nov 2015 → Jun 2016 | acute transplant rejection, chronic transplant rejection | Paul Kim | Completed | No outcome recorded |
| Phase 4 | NCT02130453 Background | Sep 2014 → Jun 2024 | ischemic disease | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 4 | NCT01919450 Comparator | Jul 2013 → Apr 2016 | — | Timothy M. Bateman, MD | Completed | No outcome recorded |
| Phase 4 | NCT01779869 Background | Jan 2013 → Jun 2015 | myocardial ischemia | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT01109992 Comparator | Feb 2011 → Jun 2017 | coronary artery disorder | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT06854458 Background | Jun 2025 → Jan 2029 expected | ischemic disease | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| — | NCT04316676 Background | Jun 2021 → Sep 2024 | coronary artery disorder | Emory University | Completed | No outcome recorded |
| — | NCT02560467 Background | Dec 2015 → Sep 2019 | hypertrophic cardiomyopathy | Oregon Health and Science University | Unknown | No outcome recorded |
| — | NCT01969916 Background | Jun 2014 → Jun 2018 | coronary artery disorder | University of Chicago | Completed | No outcome recorded |
| — | NCT01949844 Background | May 2014 → Jan 2017 | coronary artery disorder | Daniel S. Berman | Completed | No outcome recorded |
| — | NCT02608944 Background | Sep 2012 → Jun 2019 | — | University of Utah | Withdrawn | No outcome recorded |
| — | NCT01370265 Comparator | Feb 2011 → Feb 2012 | coronary artery disorder | Mayo Clinic | Completed | No outcome recorded |
| — | NCT00857792 Background | Mar 2009 → Jan 2013 | coronary artery disorder | University of Chicago | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2009-05-28 | Gilead Sciences | Gilead Sciences' Marketing Authorisation Application for Regadenoson Validated by European Medicines Agency gilead.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 60 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | regadenoson | “Pharmacologic stress agents were restricted to the following 3 agents, as permitted by local marketing authorisations and availability: adenosine, dipyridamole, and regadenoson.” NCT03354273 ↗55“All participants will receive vasodilator (regadenoson or adenosine depending on local site practice).” NCT06854458 ↗ “Vasodilator stress during MCE imaging will be performed using regadenoson at FDA-approved doses.” NCT02560467 ↗ |
| Known as | Lexiscan | “This study will evaluate the maximum safe dose and duration of regadenoson (Lexiscan) that can be given to people who are having a lung transplant.” NCT03072589 ↗8“Regadenoson is approved in the US under the brand name Lexiscan for myocardial perfusion imaging.” NCT00907764 ↗ “Regadenoson (Lexiscan, Astellas), a recently FDA approved A2A receptor agonist” NCT00881218 ↗ “Patients will be given a single dose of Lexiscan (0.4 mg, iv bolus)” NCT01969916 ↗ “Astellas Pharma, Tokyo, Japan (Lexiscan [regadenoson])” PMID 36117179 ↗ Sep 2022 “Regadenoson (Lexiscan)” NCT01109992 ↗ |
| Known as | Rapiscan | “Regadenoson (Rapiscan)” NCT01809743 ↗ |
| Known as | Regadenoson (Lexiscan) | “Regadenoson (Lexiscan)” NCT01019486 ↗ |
| Action | Activate | “regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist” NCT00208299 ↗ |
| Modality | Diagnostic / imaging agent | “as an imaging agent” NCT00763035 ↗ |
| Route | Intravenous | “0.4 mg, bolus intravenous injection” NCT00208299 ↗ |