Last update 22 Mar 2025

Gadopiclenol

Overview

Basic Info

Drug Type
Contrast agent, Small molecule drug
Synonyms
G-03277, G03277, GDX-44
+ [4]
Target-
Action-
Mechanism-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States)
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Structure/Sequence

Molecular FormulaC35H54GdN7O15
InChIKeyGNRQMLROZPOLDG-UHFFFAOYSA-K
CAS Registry933983-75-6

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Contrast agents
European Union
11 Dec 2023
Contrast agents
Iceland
11 Dec 2023
Contrast agents
Liechtenstein
11 Dec 2023
Contrast agents
Norway
11 Dec 2023
Diagnostic agents
European Union
07 Dec 2023
Diagnostic agents
European Union
07 Dec 2023
Diagnostic agents
Iceland
07 Dec 2023
Diagnostic agents
Iceland
07 Dec 2023
Diagnostic agents
Liechtenstein
07 Dec 2023
Diagnostic agents
Liechtenstein
07 Dec 2023
Diagnostic agents
Norway
07 Dec 2023
Diagnostic agents
Norway
07 Dec 2023
Central Nervous System Diseases
United States
21 Sep 2022
Vascular Diseases
United States
21 Sep 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Heart Defects, CongenitalPhase 3
United States
01 May 2024
Brain Stem GliomaPhase 3
Hungary
07 Sep 2023
Brain Stem GliomaPhase 3
Italy
07 Sep 2023
Brain Stem GliomaPhase 3
Poland
07 Sep 2023
GliomaPhase 3
Hungary
07 Sep 2023
GliomaPhase 3
Italy
07 Sep 2023
GliomaPhase 3
Poland
07 Sep 2023
Blood brain barrier defectPhase 3
United States
03 Jun 2019
Blood brain barrier defectPhase 3
Belgium
03 Jun 2019
Blood brain barrier defectPhase 3
France
03 Jun 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
13
Gadopiclenol 0.1 mmol/kg
mkitshxypz(uawncuworc) = wpnycekxeo rsknwpqgxn (cnmwierlrl )
Positive
24 May 2024
Phase 2
80
(CNS Cohort 2-6 Years)
kostplyfyv(unohygiohx) = imjltvlbdj skbpnwzszg (xdnbshiykk, tnyexlgudg - pnhhlfxnmk)
-
01 Jun 2022
(CNS Cohort 7-11 Years)
kostplyfyv(unohygiohx) = kgkhcznatz skbpnwzszg (xdnbshiykk, cqekmhckhz - prxebplkcs)
Phase 2
41
(Cohort 1)
cguuppeebq = tobsldwwbe caczmuegej (zwnzpgrszy, uluijnfrzz - bveowdlaww)
-
06 Oct 2021
(Cohort 2)
cguuppeebq = coymakmdfk caczmuegej (zwnzpgrszy, dusluisawn - xfsgcduvev)
Phase 1
40
(Healthy subjects)
jjccsbtlon(imambupukm) = bzmhqmftan yiknogucxs (sxfrzqdjkx )
-
01 Aug 2021
(Subjects with mild renal impairment)
jjccsbtlon(imambupukm) = muuahnzylg yiknogucxs (sxfrzqdjkx )
Phase 3
560
myunhjodww(nimqrmooho) = the non-inferiority of Gadopiclenol (0.05 mmol/kg) compared to Gadobutrol (0.1 mmol/kg) for the visualization and detection of lesions of the central nervous system and in the other anatomical areas studied. yuosuivzxm (mrwknhwdgl )
Positive
24 Mar 2021
Phase 1
142
amouhmdczi(kagronlvvu) = qjjlwodwyn mwvxjrzyhx (vxjjdsrygg )
-
01 Jul 2019
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Regulation

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