gadopiclenol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
diagnostic agents, gadolinium derivatives 5681 933983-75-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • gadopiclenol
  • P03277
  • elucirem
Gadopiclenol is a paramagnetic molecule (macrocyclic non-ionic complex of gadolinium) that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues.
  • Molecular weight: 970.10
  • Formula: C35H54GdN7O15
  • CLOGP: -13.59
  • LIPINSKI: 3
  • HAC: 22
  • HDO: 9
  • TPSA: 334
  • ALOGS: -2.52
  • ROTB: 24

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,JAK3,MAP2K6,MAP3K21,MAP3K7,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PIK3CB,PIM2,PRKDC,SIK2,STK33,SYK,TEK,TGFBR1,ZAP70 35
kinase-selectivity-class ACVRL1,AXL,BRAF,CDK4,CDK9,CHUK,EPHB4,GRK2,MAP2K6,PIK3CB,PIK3CD,TEK,TGFBR1 13
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Sept. 21, 2022 FDA GUERBET S.A.

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC V08CA12 VARIOUS
CONTRAST MEDIA
MAGNETIC RESONANCE IMAGING CONTRAST MEDIA
Paramagnetic contrast media
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

V08CA Paramagnetic contrast media 10 drugs

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Detect and visualize lesions with abnormal vascularity with MRI indication 767426001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1.4553GM/3ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS 12064487 Jan. 17, 2040 METHOD OF MAGNETIC RESONANCE IMAGING TO DETECT AND VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE CENTRAL NERVOUS SYSTEM (BRAIN, SPINE, AND ASSOCIATED TISSUES) AND THE BODY (HEAD AND NECK, THORAX, ABDOMEN, PELVIS, AND MUSCULOSKELETAL SYSTEM)
14.553GM/30ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS 12064487 Jan. 17, 2040 METHOD OF MAGNETIC RESONANCE IMAGING TO DETECT AND VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE CENTRAL NERVOUS SYSTEM (BRAIN, SPINE, AND ASSOCIATED TISSUES) AND THE BODY (HEAD AND NECK, THORAX, ABDOMEN, PELVIS, AND MUSCULOSKELETAL SYSTEM)
24.255GM/50ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS 12064487 Jan. 17, 2040 METHOD OF MAGNETIC RESONANCE IMAGING TO DETECT AND VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE CENTRAL NERVOUS SYSTEM (BRAIN, SPINE, AND ASSOCIATED TISSUES) AND THE BODY (HEAD AND NECK, THORAX, ABDOMEN, PELVIS, AND MUSCULOSKELETAL SYSTEM)
3.63825GM/7.5ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS 12064487 Jan. 17, 2040 METHOD OF MAGNETIC RESONANCE IMAGING TO DETECT AND VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE CENTRAL NERVOUS SYSTEM (BRAIN, SPINE, AND ASSOCIATED TISSUES) AND THE BODY (HEAD AND NECK, THORAX, ABDOMEN, PELVIS, AND MUSCULOSKELETAL SYSTEM)
4.851GM/10ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS 12064487 Jan. 17, 2040 METHOD OF MAGNETIC RESONANCE IMAGING TO DETECT AND VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE CENTRAL NERVOUS SYSTEM (BRAIN, SPINE, AND ASSOCIATED TISSUES) AND THE BODY (HEAD AND NECK, THORAX, ABDOMEN, PELVIS, AND MUSCULOSKELETAL SYSTEM)
7.2765GM/15ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS 12064487 Jan. 17, 2040 METHOD OF MAGNETIC RESONANCE IMAGING TO DETECT AND VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE CENTRAL NERVOUS SYSTEM (BRAIN, SPINE, AND ASSOCIATED TISSUES) AND THE BODY (HEAD AND NECK, THORAX, ABDOMEN, PELVIS, AND MUSCULOSKELETAL SYSTEM)

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1.4553GM/3ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS Sept. 21, 2027 NEW CHEMICAL ENTITY
14.553GM/30ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS Sept. 21, 2027 NEW CHEMICAL ENTITY
24.255GM/50ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS Sept. 21, 2027 NEW CHEMICAL ENTITY
3.63825GM/7.5ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS Sept. 21, 2027 NEW CHEMICAL ENTITY
4.851GM/10ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS Sept. 21, 2027 NEW CHEMICAL ENTITY
48.51GM/100ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS Sept. 21, 2027 NEW CHEMICAL ENTITY
7.2765GM/15ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS Sept. 21, 2027 NEW CHEMICAL ENTITY
1.4553GM/3ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS Feb. 20, 2029 NEW PATIENT POPULATION
14.553GM/30ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS Feb. 20, 2029 NEW PATIENT POPULATION
24.255GM/50ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS Feb. 20, 2029 NEW PATIENT POPULATION
3.63825GM/7.5ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS Feb. 20, 2029 NEW PATIENT POPULATION
4.851GM/10ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS Feb. 20, 2029 NEW PATIENT POPULATION
48.51GM/100ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS Feb. 20, 2029 NEW PATIENT POPULATION
7.2765GM/15ML (485.1MG/ML) ELUCIREM GUERBET N216986 Sept. 21, 2022 RX SOLUTION INTRAVENOUS Feb. 20, 2029 NEW PATIENT POPULATION

Bioactivity Summary:

None

External reference:

IDSource
CHEBI:757103 CHEBI
CHEMBL4297634 ChEMBL_ID
C000656634 MESH_SUPPLEMENTAL_RECORD_UI
DB17084 DRUGBANK_ID
4041872 VANDF
C5392287 UMLSCUI
10744 INN_ID
D12435 KEGG_DRUG
16223405 PUBCHEM_CID
368327 MMSL
41266 MMSL
d10016 MMSL
019209 NDDF
S276568KOY UNII
2618720 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Vueway HUMAN PRESCRIPTION DRUG LABEL 1 0270-7015 INJECTION 485.10 mg INTRAVENOUS NDA 27 sections
Vueway HUMAN PRESCRIPTION DRUG LABEL 1 0270-7020 INJECTION 485.10 mg INTRAVENOUS NDA 27 sections
Vueway HUMAN PRESCRIPTION DRUG LABEL 1 0270-7025 INJECTION 485.10 mg INTRAVENOUS NDA 27 sections
Vueway HUMAN PRESCRIPTION DRUG LABEL 1 0270-7030 INJECTION 485.10 mg INTRAVENOUS NDA 27 sections
Vueway HUMAN PRESCRIPTION DRUG LABEL 1 0270-7035 INJECTION 485.10 mg INTRAVENOUS NDA 27 sections
ELUCIREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-4230 INJECTION 485.10 mg INTRAVENOUS NDA 29 sections
ELUCIREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-4231 INJECTION 485.10 mg INTRAVENOUS NDA 29 sections
ELUCIREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-4232 INJECTION 485.10 mg INTRAVENOUS NDA 29 sections
ELUCIREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-4233 INJECTION 485.10 mg INTRAVENOUS NDA 29 sections
ELUCIREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-4240 INJECTION 485.10 mg INTRAVENOUS NDA 29 sections
ELUCIREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-4241 INJECTION 485.10 mg INTRAVENOUS NDA 29 sections
ELUCIREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-4242 INJECTION 485.10 mg INTRAVENOUS NDA 29 sections
ELUCIREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-4250 INJECTION 485.10 mg INTRAVENOUS NDA 29 sections
ELUCIREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-4251 INJECTION 485.10 mg INTRAVENOUS NDA 29 sections