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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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Target
Variants
Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
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
FibrosisD005355—————1—1
Endomyocardial fibrosisD004719EFO_1000921————1—1
Prostatic neoplasmsD011471—C61———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brain neoplasmsD001932EFO_0003833C71——1——1
Congenital heart defectsD006330—Q24.9——1——1
Heart diseasesD006331EFO_0003777I51.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———31———3
Hepatocellular carcinomaD006528—C22.0—1——12
Liver neoplasmsD008113EFO_1001513C22.0—1——12
Liver diseasesD008107EFO_0001421K70-K77—1——12
Multiple sclerosisD009103EFO_0003885G35—1———1
SclerosisD012598———1———1
Central nervous system diseasesD002493—G96.9—1———1
Nervous system diseasesD009422—G00-G99—1———1
Breast neoplasmsD001943EFO_0003869C50—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437—N191————1
PharmacokineticsD010599——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver cirrhosisD008103EFO_0001422K74.0————11
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 73 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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