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Regadenoson

Phase 3

Coronary Artery Disease | Small molecule | Cardiovascular |Gilead Sciences, Inc.|Last Updated: Nov 26, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment2,018
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00208312ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)PHASE3 COMPLETED 787 — — Apr 1, 2004Jun 1, 2005Nov 26, 20091 United States
NCT00208299ADVANCE MPI 1: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)PHASE3 COMPLETED 1,231 — — Oct 1, 2003Aug 1, 2006Nov 26, 20091 United States
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Study Endpoints
Primary Endpoints
Non-inferiority of regadenoson to Adenoscan for use in SPECT myocardial perfusion imaging in assessing reversible perfusion defects
After radiopharmaceutical administration
Non-inferiority of regadenoson to Adenoscan for use in single photon emission computed tomography (SPECT) myocardial perfusion imaging in assessing reversible perfusion defects
After radiopharmaceutical administration
Secondary Endpoints
Safety and tolerability comparison of regadenoson to Adenoscan
Up to two weeks
Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan
After radiopharmaceutical administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
1EXPERIMENTALRegadenoson
2ACTIVE_COMPARATORAdenoscan
Interventions
NameTypeDescription
RegadenosonDRUG0.4 mg, bolus intravenous injection
AdenosineDRUG0.14 mg/kg/min for 6 minutes, intravenous infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Referred for a clinically indicated pharmacological stress SPECT myocardial perfusion imaging study Exclusion Criteria: * Any condition precluding the safe administration of Adenoscan for a SPECT myocardial perfusion imaging study * Pregnant or breast-feeding, or (if pre-men...

Countries:United States
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Competitive Landscape -Coronary Artery Disease 99 trials
CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO5PHASE3Ziltivekimab, Tocilizumab, Dobutamine, NaCl 0.9%
Boston Scientific CorporationBSX9PHASE3Undisclosed
Novartis AG Sponsored ADRNVS4PHASE3Inclisiran
Alnylam Pharmaceuticals, IncALNY1PHASE3Zilebesiran
Viatris, Inc.VTRS1PHASE3Selatogrel
NewAmsterdam Pharma Company N.V.NAMS1PHASE3obicetrapib + ezetimibe daily
GE Healthcare Technologies Inc.GEHC3PHASE1Regadenoson
Abbott LaboratoriesABT12 — Undisclosed
HeartFlow, Inc.HTFL5 — Rosuvastatin
Medtronic PlcMDT3NAUndisclosed
Teleflex IncorporatedTFX2NAUndisclosed
AstraZeneca PLCAZN1 — Tezepelumab
BioCardia, Inc.BCDA1NAUndisclosed
Sanofi SA Sponsored ADRSNY1 — alirocumab /2week, statin ± ezetimibe
Johnson & JohnsonJNJ1NAUndisclosed
Orchestra BioMed Holdings, Inc.OBIO1NAUndisclosed
Rhythm Pharmaceuticals, Inc.RYTM2NAUndisclosed
Azienda Ospedaliera Universitaria Integrata VeronaVRNA2 — Undisclosed
Healthcare Services Group, Inc.HCSG1 — Undisclosed
Collegium Pharmaceutical, Inc.COLL1 — Flozin
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