Regadenoson

also known as Lexiscan · Rapiscan · Regadenoson (Lexiscan)

Developed for: sickle cell disease · asthma · chronic obstructive pulmonary disease · COVID-19 · pneumonitis
Investigated by: Astellas Pharma US, Inc. · Astellas Pharma Inc · Astellas Pharma Global Development, Inc. · Gilead Sciences · National Heart, Lung, and Blood Institute (NHLBI) · University of Maryland, Baltimore
+32 more
· Dana-Farber Cancer Institute · GE Healthcare · La Jolla Institute for Allergy & Immunology · Medical College of Wisconsin · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · University of Utah · Washington University School of Medicine · Astellas Scientific & Medical Affairs, Inc. · Boston Children's Hospital · Brigham and Women's Hospital · Christine Lau, MD · Covance · Dipan Shah · Hartford Hospital · Johns Hopkins University · Marvin W. Kronenberg, M.D. · National Cancer Institute (NCI) · National Jewish Health · Ochsner Health System · Oregon Health and Science University · Saint Luke's Cardiovascular Consultants · Saint Luke's Health System · St. Louis University · Timothy M. Bateman · University of Aarhus · University of Alabama at Birmingham · University of Chicago · University of Colorado, Denver · University of Florida · University of Illinois at Chicago · University of Nebraska · Versiti Blood Health

Regulatory milestones approvals, filings & regulatory actions · 4 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 ↗
Filed	EU (EMA)	—	—	2009-05-28	“Marketing Authorisation Application (MAA) for regadenoson, an investigational pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI), was validated by...” gilead.com ↗
Approved	US (FDA)	LEXISCAN	—	2008-04-10	fda.gov ↗

Trials 31

today

US approved 2008

EU approved 2010

NCT04604782 · Ph 1/2 NCT04606069 · Ph 1/2 NCT04521569 · Ph 0 NCT03971734 · Ph 1 NCT03072589 · Ph 1 NCT03090087 · Ph 2 NCT02589977 · Ph 4 NCT02389738 · Ph 0 NCT02115308 · Ph 4 NCT02220634 · not/applicable NCT01918995 · Ph 1 NCT01842035 · not/applicable NCT01710254 · Ph 2 NCT01489176 · Ph 3 NCT01566890 · not/applicable NCT01618669 · Ph 3 NCT01482169 · not/applicable NCT01446094 · Ph 4 NCT01161121 · Ph 1 NCT01085201 · Ph 1 NCT01021618 · not/applicable NCT01026012 · not/applicable NCT01019486 · Ph 4 NCT00881218 · Ph 0 NCT00907764 · Ph 2 NCT00871260 · Ph 4 NCT00862641 · Ph 4 NCT00863707 · Ph 4 NCT00859833 · not/applicable NCT00208312 · Ph 3 NCT00208299 · Ph 3

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

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 · 1 missed
Phase 1	NCT03971734	Dec 2019 → Apr 2022	anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Terminated	Missed primary
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 Stop: Enrollment
Phase 34 trials · 2 met primary
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	Met primary
Phase 3	NCT00208312	Apr 2004 → Jun 2005	coronary artery disorder	Gilead Sciences	Completed	Met primary
Phase 3	NCT00208299	Oct 2003 → Aug 2006	coronary artery disorder	Gilead Sciences	Completed	No outcome recorded
Phase 47 trials · 1 missed
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	NCT00871260	Apr 2009 → Jun 2014	coronary artery disorder	University of Chicago	Completed	No outcome recorded
Phase 4	NCT00862641	Apr → Oct 2009	asthma, chronic obstructive pulmonary disease, coronary artery disorder	Astellas Pharma Inc	Completed	Missed primary
Phase 4	NCT00863707	Apr → Dec 2009	chronic kidney disease, coronary artery disorder	Astellas Pharma Inc	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
Comparator or background therapy28 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 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 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 3	NCT03354273 Background	Jun 2018 → May 2022	coronary artery disorder	GE Healthcare	Completed	Met primary
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	Met primary
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 Stop: Business
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
—	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

News releases announcing trial results or a regulatory action · 2

Date	Issuer	Release
2022-05-24	Amphastar Pharmaceuticals, Inc.	Regulatory Amphastar Receives FDA Approval for Regadenoson amphastar.com ↗ Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for Regadenoson injection, 0.08 mg/mL, 5mL Single Dose Pre-Filled Syringe.
2009-05-28	Gilead Sciences	Regulatory Gilead Sciences' Marketing Authorisation Application for Regadenoson Validated by European Medicines Agency gilead.com ↗ Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Marketing Authorisation Application (MAA) for regadenoson, an investigational pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI), was validated by the European Medicines Agency (EMEA).

All press releases naming this drug 6 releases

Date	Issuer	Release
2023-05-11	Astellas Pharma Inc	Astellas Confirms Final Federal Circuit Decision in LEXISCAN ® 0.4 mg/mL U.S. Patent Appeal astellas.com ↗
2023-01-04	Astellas Pharma Inc	Astellas Confirms Unfavorable Federal Circuit Decision in LEXISCAN ® 0.4 mg/mL U.S. Patent Trial astellas.com ↗
2022-09-26	Astellas Pharma Inc	Astellas Confirms District Court Decision for an Interim Injunction Against Hospira for LEXISCAN® 0.4mg/mL astellas.com ↗
2022-05-24	Amphastar Pharmaceuticals, Inc.	Amphastar Receives FDA Approval for Regadenoson amphastar.com ↗
2022-05-20	Astellas Pharma Inc	Astellas Confirms Unfavorable District Court Decision in LEXISCAN® 0.4mg/mL U.S. Patent Trial astellas.com ↗
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 ↗ NCT01026012 ↗ NCT01370265 ↗ NCT01919450 ↗ NCT01618669 ↗ NCT01788631 ↗ NCT01334918 ↗ NCT01446094 ↗ NCT04521569 ↗ Show 45 more sources
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 ↗ NCT01085201 ↗ NCT03103061 ↗ NCT05583721 ↗
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 ↗