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1. 3,6,9,15-tetraazabicyclo(9.3.1)pentadeca-1(15),11,13-triene-3,6,9-triacetic Acid, Alpha, Alpha', Alpha''-tris(3-((2,3-dihydroxypropyl)amino)-3-oxopropyl)-, Gadolinium Salt (1:1)
2. Gadolinium 2,2',2''-(3,6,9,15-tetraazabicyclo(9.3.1)pentadeca-1(15),11,13-triene-3,6,9-triyl)tris(5-((2,3-dihydroxypropyl)amino)-5-oxopentanoate)
1. Unii-s276568koy
2. Gadopiclenol [usan]
3. S276568koy
4. Elucirem
5. P03277
6. Who 10744
7. 933983-75-6
8. P-03277
9. (alpha3,alpha6,alpha9-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-)-kappan3,kappan6,kappan9,kappan15,kappao3,kappao6,kappao9)gadolinium
10. 2-[3,9-bis[1-carboxylato-4-(2,3-dihydroxypropylamino)-4-oxobutyl]-3,6,9,15-tetrazabicyclo[9.3.1]pentadeca-1(15),11,13-trien-6-yl]-5-(2,3-dihydroxypropylamino)-5-oxopentanoate;gadolinium(3+)
11. Gadopiclenolum
12. Vueway
13. Gadopiclenol [inn]
14. Schembl21682611
15. Gbca P03277
16. P 03277
17. Gadolinium-based Magnetic Resonance Contrast Agent P03277
18. (.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
19. Gadolinium, (.alpha.3, .alpha.6, .alpha.9-tris(3-((2-hydroxy-1-(hydroxymethyl)ethyl)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)
20. Gadolinium, (alpha3, Alpha6, Alpha9-tris(3-((2-hydroxy-1-(hydroxymethyl)ethyl)amino)-3-oxopropyl)-3,6,9,15-tetraazabicyclo(9.3.1)pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-kappan3, Kappan6, Kappan9, Kappan15, Kappao3, Kappao6, Kappao9)
Molecular Weight | 970.1 g/mol |
---|---|
Molecular Formula | C35H54GdN7O15 |
Hydrogen Bond Donor Count | 9 |
Hydrogen Bond Acceptor Count | 19 |
Rotatable Bond Count | 21 |
Exact Mass | g/mol |
Monoisotopic Mass | g/mol |
Topological Polar Surface Area | 352 |
Heavy Atom Count | 58 |
Formal Charge | 0 |
Complexity | 1200 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 6 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Gadopiclenol is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) 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).
Detection and visualization of disorders or lesions with suspected abnormal vascularity in various body regions for diagnostic purposes
Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes
V - Various
V08 - Contrast media
V08C - Magnetic resonance imaging contrast media
V08CA - Paramagnetic contrast media
V08CA12 - Gadopiclenol
Absorption
At a dose range between 0.025 mmol/kg and 0.3 mmol/kg (0.5 times to 6 times the recommended dosage), the Cmax and AUCinf of gadopiclenol increases in a dose-proportional manner. At the recommended dose, gadopiclenol has a Cmax of 525 g/mL and an AUCinf of 569 gh/mL. A study that evaluated the pharmacokinetic parameters of gadopiclenol in healthy subjects and patients with brain lesions did not detect significant differences between the two groups.
Route of Elimination
Gadopiclenol is mainly excreted in urine by glomerular filtration. Within 48 hours after administration, approximately 98% of the gadopiclenol dose was recovered in urine.
Volume of Distribution
At steady state, the mean volume of distribution of gadopiclenol is 13 L.
Clearance
Gadopiclenol has a total body clearance of 100 mL/min and a renal clearance of 81 mL/min.
Gadopiclenol is not metabolized and is eliminated unchanged.
Gadopiclenol has a mean elimination half-life of is 1.5 hours.
Gadopiclenol is a macrocyclic non-ionic complex of gadolinium and a paramagnetic molecule 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. Its use in magnetic resonance imaging (MRI) allows to selectively increase contrast in tissues where gadopiclenol accumulates.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Details:
Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Contrast Enhanced Imaging.
Lead Product(s): Gadopiclenol,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 26, 2025
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Contrast Enhanced Imaging.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 26, 2025
Details:
Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Heart Defects, Congenital.
Lead Product(s): Gadopiclenol,Inapplicable
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Bracco
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 09, 2024
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Bracco
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Heart Defects, Congenital.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 09, 2024
Details:
Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Prostatic Neoplasms.
Lead Product(s): Gadopiclenol,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: GUERBET
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 26, 2024
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : GUERBET
Deal Size : Inapplicable
Deal Type : Inapplicable
Gadopiclenol in Contrast Enhanced MRI of the Prostate
Details : Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Prostatic Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 26, 2024
Details:
Elucirem (Gadopiclenol) is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Brain Neoplasms.
Lead Product(s): Gadopiclenol,Inapplicable
Therapeutic Area: Oncology Brand Name: Elucirem
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 28, 2023
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas
Details : Elucirem (Gadopiclenol) is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Brain Neoplasms.
Product Name : Elucirem
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 28, 2023
Details:
Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Brain Lesions.
Lead Product(s): Gadopiclenol,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Bracco
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 24, 2023
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Bracco
Deal Size : Inapplicable
Deal Type : Inapplicable
Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children
Details : Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Brain Lesions.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 24, 2023
Details:
Elucirem (Gadopiclenol) is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Myocardial Fibrosis.
Lead Product(s): Gadopiclenol,Inapplicable
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Elucirem
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: GUERBET
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 20, 2023
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : GUERBET
Deal Size : Inapplicable
Deal Type : Inapplicable
High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment
Details : Elucirem (Gadopiclenol) is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Myocardial Fibrosis.
Product Name : Elucirem
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 20, 2023
Details:
Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Central Nervous System Diseases.
Lead Product(s): Gadopiclenol,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 21, 2022
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age
Details : Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Central Nervous System Diseases.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 21, 2022
Details:
Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Gadopiclenol,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 28, 2021
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers
Details : Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 28, 2021
Details:
Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Brain Lesions.
Lead Product(s): Gadopiclenol,Gadobutrol
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 24, 2019
Lead Product(s) : Gadopiclenol,Gadobutrol
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Brain Lesions.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 24, 2019
Details:
Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of undefined medical condition.
Lead Product(s): Gadopiclenol,Gadobutrol
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 14, 2019
Lead Product(s) : Gadopiclenol,Gadobutrol
Therapeutic Area : Undisclosed
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
Details : Gadopiclenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 14, 2019
CAS Number : 99-32-1
End Use API : Gadopiclenol
About The Company : We are one of the well-known manufacturers of key APIs & intermediates in China, with 20 years of experience & presence in 20+ countries. At Boyuan, we are comm...
CAS Number : 138-60-3
End Use API : Gadopiclenol
About The Company : We are one of the well-known manufacturers of key APIs & intermediates in China, with 20 years of experience & presence in 20+ countries. At Boyuan, we are comm...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 48.51G/100ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : Italy
Brand Name : Vueway
Dosage Form : Injection
Dosage Strength : 0.5 MMOL/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Vueway
Dosage Form : Solution for injection
Dosage Strength : 0.5 mmol/ml
Packaging : Vials 7.5ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : RX
Registration Country : USA
Brand Name : ELUCIREM
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 1.4553GM/3ML (485.1MG/ML)
Packaging :
Approval Date : 2022-09-21
Application Number : 216986
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ELUCIREM
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 3.63825GM/7.5ML (485.1MG/ML)
Packaging :
Approval Date : 2022-09-21
Application Number : 216986
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ELUCIREM
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 4.851GM/10ML (485.1MG/ML)
Packaging :
Approval Date : 2022-09-21
Application Number : 216986
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ELUCIREM
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 7.2765GM/15ML (485.1MG/ML)
Packaging :
Approval Date : 2022-09-21
Application Number : 216986
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ELUCIREM
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 14.553GM/30ML (485.1MG/ML)
Packaging :
Approval Date : 2022-09-21
Application Number : 216986
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ELUCIREM
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 24.255GM/50ML (485.1MG/ML)
Packaging :
Approval Date : 2022-09-21
Application Number : 216986
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ELUCIREM
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 48.51GM/100ML (485.1MG/ML)
Packaging :
Approval Date : 2022-09-21
Application Number : 216986
Regulatory Info : RX
Registration Country : USA
Global Sales Information
Patents & EXCLUSIVITIES
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PharmaCompass offers a list of Gadopiclenol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Gadopiclenol manufacturer or Gadopiclenol supplier for your needs.
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A Gadolinium-based Magnetic Resonance Contrast Agent P03277 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadolinium-based Magnetic Resonance Contrast Agent P03277, including repackagers and relabelers. The FDA regulates Gadolinium-based Magnetic Resonance Contrast Agent P03277 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadolinium-based Magnetic Resonance Contrast Agent P03277 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Gadolinium-based Magnetic Resonance Contrast Agent P03277 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gadolinium-based Magnetic Resonance Contrast Agent P03277 supplier is an individual or a company that provides Gadolinium-based Magnetic Resonance Contrast Agent P03277 active pharmaceutical ingredient (API) or Gadolinium-based Magnetic Resonance Contrast Agent P03277 finished formulations upon request. The Gadolinium-based Magnetic Resonance Contrast Agent P03277 suppliers may include Gadolinium-based Magnetic Resonance Contrast Agent P03277 API manufacturers, exporters, distributors and traders.
click here to find a list of Gadolinium-based Magnetic Resonance Contrast Agent P03277 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
Gadolinium-based Magnetic Resonance Contrast Agent P03277 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Gadolinium-based Magnetic Resonance Contrast Agent P03277 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Gadolinium-based Magnetic Resonance Contrast Agent P03277 GMP manufacturer or Gadolinium-based Magnetic Resonance Contrast Agent P03277 GMP API supplier for your needs.
A Gadolinium-based Magnetic Resonance Contrast Agent P03277 CoA (Certificate of Analysis) is a formal document that attests to Gadolinium-based Magnetic Resonance Contrast Agent P03277's compliance with Gadolinium-based Magnetic Resonance Contrast Agent P03277 specifications and serves as a tool for batch-level quality control.
Gadolinium-based Magnetic Resonance Contrast Agent P03277 CoA mostly includes findings from lab analyses of a specific batch. For each Gadolinium-based Magnetic Resonance Contrast Agent P03277 CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Gadolinium-based Magnetic Resonance Contrast Agent P03277 may be tested according to a variety of international standards, such as European Pharmacopoeia (Gadolinium-based Magnetic Resonance Contrast Agent P03277 EP), Gadolinium-based Magnetic Resonance Contrast Agent P03277 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gadolinium-based Magnetic Resonance Contrast Agent P03277 USP).