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 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
CYCLOLUX SOLUTION FOR INJECTION 5.65G/15ML | N/A | N/A | N/A | 8/15/2024 | |
CYCLOLUX SOLUTION FOR INJECTION 22.62G/60ML | N/A | N/A | N/A | 8/15/2024 | |
CYCLOLUX SOLUTION FOR INJECTION 3.77G/10ML | N/A | N/A | N/A | 8/15/2024 | |
CYCLOLUX SOLUTION FOR INJECTION 37.69G/100ML | N/A | N/A | N/A | 8/15/2024 | |
CYCLOLUX SOLUTION FOR INJECTION 7.54G/20ML | N/A | N/A | N/A | 8/15/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
DOTAGRAF gadoteric acid 5.59 g/20 mL solution for injection vial | 371171 | Medicine | A | 10/19/2022 | |
CLARISCAN gadoteric acid 2.793g/10mL solution for injection vial | 290160 | Medicine | A | 1/11/2018 | |
CLARISCAN gadoteric acid 1.397g/5mL solution for injection vial | 284859 | Medicine | A | 1/11/2018 | |
DOTAREM gadoteric acid 279.32mg/mL injection 10 mL pre-filled syringe | 160798 | Medicine | A | 8/26/2010 | |
DOTAGRAF gadoteric acid 2.79 g/10 mL solution for injection vial | 351770 | Medicine | A | 10/19/2022 | |
DOTAGRAF gadoteric acid 27.93 g/100 mL solution for injection bottle | 371173 | Medicine | A | 10/19/2022 | |
CLARISCAN gadoteric acid 4.190g/15mL solution for injection pre-filled syringe | 290159 | Medicine | A | 1/11/2018 | |
DOTAREM gadoteric acid 279.32mg/mL injection 10mL vial | 76925 | Medicine | A | 12/11/2000 | |
CLARISCAN gadoteric acid 2.793g/10mL solution for injection pre-filled syringe | 284860 | Medicine | A | 1/11/2018 | |
DOTAREM gadoteric acid 279.32mg/mL injection 20mL vial | 76923 | Medicine | A | 12/11/2000 |
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