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Drug

Gadopiclenol

Approved · EMA
Emerging researchLate-stage development

Also known as (.alpha.3,.alpha.6,.alpha.9-tris(3-((2,3-dihydroxypropyl)amino)-3-oxopropyl)-3,6,9,15-tetraazabicyclo(9.3.1)pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-.kappa.n3,.kappa.n6,.kappa.n9,.kappa.n15,.kappa.o3,.kappa.o6,.kappa.o9)gadolinium.

RxNorm2618720UNIIS276568KOY
2
Research papers
4
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI: A Pilot Study

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age

Clinical trial2025-10-28Results posted · ClinicalTrials.gov

Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

Clinical trial2025-10-27Results posted · ClinicalTrials.gov

Approval: Elucirem (EMA)

Regulatory2023-12-07EMA

Approval: Vueway (EMA)

Regulatory2023-12-07EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Gadopiclenol
Aliases & brands
(.alpha.3,.alpha.6,.alpha.9-tris(3-((2,3-dihydroxypropyl)amino)-3-oxopropyl)-3,6,9,15-tetraazabicyclo(9.3.1)pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-.kappa.n3,.kappa.n6,.kappa.n9,.kappa.n15,.kappa.o3,.kappa.o6,.kappa.o9)gadolinium
RxNorm CUI
2618720
UNII
S276568KOY
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-12-07
Latest approval
2023-12-07
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2023-12-07Approval
Approval: Elucirem (EMA)
Indication: This medicinal product is for diagnostic use only.Elucirem is indicated in adults and children from birth for contrast-enhanced magnetic resonance imaging (MRI) to improveShow full indication

This medicinal product is for diagnostic use only.Elucirem is indicated in adults and children from birth for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:- the brain, spine, and associated tissues of the central nervous system (CNS);- the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.It should be used only when diagnostic information is essential and not available with unenhanced MRI.

Evidence ↗
2023-12-07Approval
Approval: Vueway (EMA)
Indication: This medicinal product is for diagnostic use only.Vueway is indicated in adults and children from birth for contrast-enhanced magnetic resonance imaging (MRI) to improve detectionShow full indication

This medicinal product is for diagnostic use only.Vueway is indicated in adults and children from birth for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:- the brain, spine, and associated tissues of the central nervous system (CNS);- the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.It should be used only when diagnostic information is essential and not available with unenhanced MRI.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

10 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
10
registered trials across all phases
LATEST COMPLETION 2025
4
Active studies
4
Recruiting
8
Late-stage (III+)
5
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 10
Phase 11Phase 21Phase 35Phase 43

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes2
Brain Neoplasms2Organometallic Compounds2
Journals, researchers & institutions
Top journals
  • Investigative radiology1
  • Radiology1
Leading researchers
  • Bago A1
  • Bereczki D1
  • Csőszi T1
  • Dziadziuszko K1
  • Hutóczki G1
  • Kolumban B1
  • Kuhl C1
  • Lee JM1
Leading institutions
free-text, unnormalised
  • Aachen University Hospital1
  • National Institute of Clinical Neurosciences1
  • Semmelweis University.1
  • University of Debrecen1
  • University of Pécs1
  • University of Pennsylvania1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.