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Drug ReportsGadopiclenol
Gadopiclenol
Elucirem (gadopiclenol) is a small molecule pharmaceutical. Gadopiclenol was first approved as Elucirem on 2022-09-21.
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Elucirem
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gadopiclenol
Tradename
Company
Number
Date
Products
ELUCIREMGuerbetN-216986 RX2022-09-21
7 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
eluciremNew Drug Application2024-05-26
vuewayNew Drug Application2024-08-09
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
GADOPICLENOL, ELUCIREM, GUERBET
2027-09-21NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Gadopiclenol, Elucirem, Guerbet
115902462040-01-17DP
109739342039-08-06DP
81148632028-09-19DP
ATC Codes
V: Various drug classes in atc
V08: Contrast media
V08C: Magnetic resonance imaging contrast media
V08CA: Paramagnetic contrast media
V08CA12: Gadopiclenol
HCPCS
No data
Clinical
Clinical Trials
21 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FibrosisD00535511
Endomyocardial fibrosisD004719EFO_100092111
Prostatic neoplasmsD011471C6111
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brain neoplasmsD001932EFO_0003833C7111
Congenital heart defectsD006330HP_0001627Q24.911
Heart diseasesD006331EFO_0003777I51.911
Indications Phases 2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N1911
PharmacokineticsD01059911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver cirrhosisD008103EFO_0001422K74.011
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGadopiclenol
INNgadopiclenol
Description
Gadopiclenol, sold under the brand name Elucirem among others, is a contrast agent used with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system and in the body. Gadopiclenol is a paramagnetic macrocyclic non-ionic complex of gadolinium.
Classification
Small molecule
Drug classgadolinium derivatives (principally for diagnostic use)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID933983-75-6
RxCUI
ChEMBL IDCHEMBL4297634
ChEBI ID
PubChem CID16223405
DrugBank
UNII IDS276568KOY (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 68 documents
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Safety
Black-box Warning
Black-box warning for: Elucirem, Vueway
Adverse Events
Top Adverse Reactions
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46 adverse events reported
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