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Regadenoson

Phase 1

Myocardial Ischemia | Small molecule | Cardiovascular |GE HealthCare Technologies Inc.|Last Updated: May 6, 2026

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04604782A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric PatientsPHASE1 RECRUITING 54May 20, 2021Dec 1, 2026May 6, 20265 France, Greece +2
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Study Endpoints
Primary Endpoints
Occurrence of Adverse Events (AEs) following administration of Regadenoson
70 hours after Regadenoson administration

An overall summary of AEs, SAEs, and Regadenoson-emergent AEs will be presented, coded using the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class and preferred term.

Changes in physical examinations following administration of Regadenoson
Baseline and 2 hours after Regadenoson administration

The number of patients with changes in physical examination status from normal at baseline to abnormal at each post-administration time point will be summarized.

Changes in oxygen saturation following administration of Regadenoson
Baseline, 15 and 5 minutes before Regadenoson administration and 1, 3, 6, 10, 15, 30 minutes and 1, 2 hours after Regadenoson administration

The occurrence of post-administration vital sign values outside the normal limits will be summarized.

Changes in blood pressure in mmHg following administration of Regadenoson
Baseline, 15 and 5 minutes before Regadenoson administration and 1, 3, 6, 10, 15, 30 minutes and 1, 2 hours after Regadenoson administration

The occurrence of post-administration vital sign values outside the normal limits will be summarized.

Changes in heart rate as bpm following administration of Regadenoson
Baseline, 15 and 5 minutes before Regadenoson administration and 1, 3, 6, 10, 15, 30 minutes and 1, 2 hours after Regadenoson administration

The occurrence of post-administration vital sign values outside the normal limits will be summarized.

Changes in body temperature (as degree C) following administration of Regadenoson
Baseline and 2 hours after Regadenoson administration

The occurrence of post-administration body temperature values outside the normal limits will be summarized by counts and percentages by age group and actual dose.

Change from baseline in the results of 12-lead electrocardiograms (ECGs) following administration of Regadenoson
Baseline, 1 and 2 hours after Regadenoson administration

Descriptive statistics will be used to describe the observed values and change from baseline for ECG intervals (RR, QT, QTcF\[Fridericia\])

Changes in serum chemistry following administration of regadenoson
Baseline and 2 hours after Regadenoson administration

The occurrence of post-administration clinical laboratory values outside the normal limits will be summarized.

Time changes of regadenoson blood concentrations (ng/mL) with a single, body-weight adjusted i.v. dose in 3 paediatric populations: adolescents 12 to <18 years,children 2 to <12 years, and infants 1 to <24 months, and who weigh at least 3kg.
1, 3, 5, 10, and 20 minutes and 1 and 2 hours post Regadenoson administration

Blood samples for PK assessment will be collected and processed for measurement of Regadenoson blood concentrations. Concentration-time profiles will be evaluated using compartmental methods and a population approach with mixed-effect modelling. A summary will be listed by patient and summarized by age group and actual dose at each time point.

Secondary Endpoints
Determine the correlation between regadenoson PK concentration (ng/mL) and changes in HR (bpm), including impact of patient factors.
1, 3, 5, 10, and 20 minutes and 1 and 2 hours post Regadenoson administration
Determine the associated myocardial hyperaemic response after administration of regadenoson using dynamic first-pass perfusion magnetic resonance imaging (MRI).
1 hour post Regadenoson administration.
Determine the associated myocardial hyperaemic response after administration of regadenoson using dynamic first-pass quantitative myocardial perfusion reserve (MPR) analysis.
1 hour post Regadenoson administration.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
adolescents aged 12 to <18 yearsEXPERIMENTAL -
children aged 2 to <12 yearsEXPERIMENTAL -
infants aged 1 to <24 months and who weigh at least 3 kgEXPERIMENTAL -
Interventions
NameTypeDescription
RegadenosonDRUGRegadenoson (Rapiscan®): Single i.v. bolus dose in stress rest CMR
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Eligibility Criteria
Age Range4 Weeks — 18 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * \* Male or female adolescent aged from 12 to \<18 years (Cohort A) or child aged from 2 to \<12 years (Cohort B) or infant aged from 1 to \<24 months (Cohort C). * Patient weighs at least 3 kg. * Patients who need to undergo a clinically indicated pharmacologic stress per...

Countries:FranceGreeceItalyUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT04604782Phase: PHASE1/PHASE2 → PHASE1
LOWMay 24, 2026NCT04604782studyFirstPostDate: changed