MedPath

Gadoteric acid

Generic Name
Gadoteric acid
Brand Names
Dotarem
Drug Type
Small Molecule
Chemical Formula
C16H25GdN4O8
CAS Number
72573-82-1
Unique Ingredient Identifier
QVF9Y6955W

Overview

Gadoteric acid is a macrocycle-structured gadolinium-based MRI contrast agent. It is composed of the organic acid DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid) used for its chelating properties, and gadolinium (Gd3+). As a paramagnetic molecule, gadoterate develops a magnetic moment when placed in a magnetic field. This magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues. More specifically, it reduces the T1 relaxation time (and to some extent the T2 and T2* relaxation times) in NMR, which is the source of its clinical utility. Increased signal brightness allows it to be used in imaging of blood vessels and of inflamed or diseased tissue where the blood vessels become 'leaky'. Gadoteric acid, as the FDA approved product Dotarem, is indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Indication

Gadoteric acid is indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/12/12
Phase 2
Recruiting
2024/09/19
Phase 1
Not yet recruiting
2024/08/01
Phase 2
Recruiting
Peter Caravan
2023/09/28
Phase 3
Completed
2023/06/23
Phase 3
Completed
2023/06/23
Phase 3
Completed
2022/06/14
Phase 2
Recruiting
2020/05/04
Phase 4
Recruiting
2019/04/10
N/A
Completed
2018/11/05
Phase 4
Recruiting
University of Massachusetts, Worcester

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Fresenius Kabi USA, LLC
65219-084
INTRAVENOUS
376.9 mg in 1 mL
8/31/2023
Fresenius Kabi USA, LLC
65219-080
INTRAVENOUS
376.9 mg in 1 mL
8/31/2023
Guerbet LLC
67684-2000
INTRAVENOUS
376.9 mg in 1 mL
1/10/2023
Guerbet LLC
67684-2000
Intravenous
376.9 mg in 1 mL
4/27/2022
Fresenius Kabi USA, LLC
65219-082
INTRAVENOUS
376.9 mg in 1 mL
8/31/2023
Slate Run Pharmaceuticals, LLC
70436-123
INTRAVENOUS
376.9 mg in 1 mL
4/16/2025
Fresenius Kabi USA, LLC
65219-088
INTRAVENOUS
376.9 mg in 1 mL
8/31/2023
Slate Run Pharmaceuticals, LLC
70436-123
INTRAVENOUS
376.9 mg in 1 mL
4/16/2025
GE Healthcare
0407-2943
INTRAVENOUS
376.9 mg in 1 mL
12/30/2022
GE Healthcare
0407-2943
INTRAVENOUS
376.9 mg in 1 mL
12/30/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
DOTAGRAF SOLUTION FOR INJECTION 0.5 MMOL/ML
SIN15973P
INJECTION, SOLUTION
279.32mg/ml (equivalent to 0.5 mmol/ml)
7/6/2020
DOTAREM INJECTION 27.932 g/ 100 ml
SIN09008P
INJECTION
27.932 g/ 100 ml
11/18/1996
CLARISCAN SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 MMOL/ML
SIN15694P
INJECTION, SOLUTION
279.3mg/ml
5/24/2019
CLARISCAN SOLUTION FOR INJECTION IN VIAL 0.5 MMOL/ML
SIN15693P
INJECTION, SOLUTION
279.3mg/ml
5/24/2019

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Gadoteric Acid Meglumine Salt Injection
国药准字H20253629
化学药品
注射剂
3/18/2025
Gadoteric Acid Meglumine Salt Injection
国药准字H20244099
化学药品
注射剂
6/18/2024
Gadoteric Acid Meglumine Salt Injection
国药准字H20243900
化学药品
注射剂
6/4/2024
Gadoteric Acid Meglumine Salt Injection
国药准字H20244100
化学药品
注射剂
6/18/2024
Gadoteric Acid Meglumine Salt Injection
国药准字H20244098
化学药品
注射剂
6/18/2024
Gadoteric Acid Meglumine Salt Injection
国药准字HJ20160127
化学药品
注射剂
2/10/2021
Gadoteric Acid Meglumine Salt Injection
国药准字H20249641
化学药品
注射剂
12/1/2024
Gadoteric Acid Meglumine Salt Injection
国药准字HJ20160129
化学药品
注射剂
2/10/2021
Gadoteric Acid Meglumine Salt Injection
国药准字H20249642
化学药品
注射剂
12/1/2024
Gadoteric Acid Meglumine Salt Injection
国药准字H20249640
化学药品
注射剂
12/1/2024

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